Orange Book CompanionŽ
Company names starting with "A"

Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.

AAA USA INC
LUTATHERA (SOLUTION) (INTRAVENOUS) LUTETIUM DOTATATE LU-177
NDA Applicant: AAA USA INC NDA No.: 208700 Prod. No.: 001 RX (10mCi/ML)

Patents	Expiration	Patented Use
Pat. No. 10596276 DP* Stable, concentrated radionuclide complex solutions Claim Types: Product-by-proces; Process Pat. Sub. Date(s): 001: Apr 13, 2020	Jul 25, 2038
Pat. No. 10596278 DP* Stable, concentrated radionuclide complex solutions Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 13, 2020	Jul 25, 2038
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jan 26, 2023
Exclusivity Code: ODE - Orphan drug exclusivity	Jan 26, 2025	ODE-166: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS) including foregut, midgut, and hindgut neuroendocrine tumors in adults

AAA USA INC
NETSPOT (POWDER) (INTRAVENOUS) GALLIUM DOTATATE GA-68
NDA Applicant: AAA USA INC NDA No.: 208547 Prod. No.: 001 RX (2.1-5.5mCi/ML)

Patents Expiration Patented Use

Pat. No. 9375498 DP* Process for the preparation of complexes of .sup.68Ga
Claim Types: Kit; Product-by-process; Drug in a container; Process
Pat. Sub. Date(s): 001: Jul 9, 2018 Aug 10, 2032

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Jun 1, 2023 ODE-120: For use after radiolabeling with Ga 68, with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

Patents	Expiration	Patented Use
Pat. No. 9375498 DP* Process for the preparation of complexes of .sup.68Ga Claim Types: Kit; Product-by-process; Drug in a container; Process Pat. Sub. Date(s): 001: Jul 9, 2018	Aug 10, 2032
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Jun 1, 2023	ODE-120: For use after radiolabeling with Ga 68, with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

AAA USA NOVARTIS
PLUVICTO (SOLUTION) (INTRAVENOUS) LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
NDA Applicant: AAA USA NOVARTIS NDA No.: 215833 Prod. No.: 001 RX (27mCi/ML)

Patents Expiration Patented Use

Pat. No. 10398791 DS* DP* Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Apr 20, 2022 Oct 17, 2034

Pat. No. 10406240 DS* DP* PSMA binding ligand-linker conjugates and methods for using
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Apr 20, 2022 Aug 15, 2028 U-3345: For treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (MCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Mar 23, 2027

Patents	Expiration	Patented Use
Pat. No. 10398791 DS* DP* Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Apr 20, 2022	Oct 17, 2034
Pat. No. 10406240 DS* DP* PSMA binding ligand-linker conjugates and methods for using Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Apr 20, 2022	Aug 15, 2028	U-3345: For treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (MCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Mar 23, 2027

AADI
FYARRO (POWDER) (INTRAVENOUS) SIROLIMUS
Drug Classes: Immunological Agents:Immunosuppressants == kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: AADI NDA No.: 213312 Prod. No.: 001 RX (100MG/VIAL)

Patents Expiration Patented Use

Pat. No. 8911786 DP* Nanoparticle comprising rapamycin and albumin as anticancer agent
Claim Types: Method of use; Formulation; Kit
Pat. Sub. Date(s): 001: Dec 17, 2021 Feb 14, 2029 U-3259: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA)

Pat. No. 10206887 DP* Prion free nanoparticle compositions and methods of making thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 17, 2021 Apr 15, 2030

Pat. No. 10705070 DP* Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
Claim Types: Process
Pat. Sub. Date(s): 001: Dec 17, 2021 Mar 5, 2036

Pat. No. 10973806 Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2021 Jun 29, 2036 U-3258: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose between about 56 mg/m2 and about 100 mg/m2 administered on days 1 and 8 of a 21-day cycle

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NP - New product Nov 22, 2024

Patents	Expiration	Patented Use
Pat. No. 8911786 DP* Nanoparticle comprising rapamycin and albumin as anticancer agent Claim Types: Method of use; Formulation; Kit Pat. Sub. Date(s): 001: Dec 17, 2021	Feb 14, 2029	U-3259: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA)
Pat. No. 10206887 DP* Prion free nanoparticle compositions and methods of making thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2021	Apr 15, 2030
Pat. No. 10705070 DP* Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Claim Types: Process Pat. Sub. Date(s): 001: Dec 17, 2021	Mar 5, 2036
Pat. No. 10973806 Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2021	Jun 29, 2036	U-3258: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose between about 56 mg/m2 and about 100 mg/m2 administered on days 1 and 8 of a 21-day cycle
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Nov 22, 2024

ABBVIE
ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ABBVIE NDA No.: 022309 Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)) NDA No.: 022309 Prod. No.: 002 DISC (1.62% (20.25MG/1.25GM PACKET)); 003 DISC (1.62% (40.5MG/2.5GM PACKET))

Patents Expiration Patented Use

Pat. No. 8466136 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 24, 2013 Oct 12, 2026

Pat. No. 8466137 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2013 Oct 12, 2026 U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

Pat. No. 8466138 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 24, 2013 Oct 12, 2026 U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

Pat. No. 8486925 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2013 Oct 12, 2026

Pat. No. 8729057 DP* Testosterone gel and method of use
Claim Types: Composition
Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014 Oct 12, 2026

Pat. No. 8741881 Testosterone gel and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2014 Oct 12, 2026 U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

Pat. No. 8754070 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 16, 2014 Oct 12, 2026

Pat. No. 8759329 DP* Testosterone gel and method of use
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 9, 2014 Oct 12, 2026

Patents	Expiration	Patented Use
Pat. No. 8466136 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 24, 2013	Oct 12, 2026
Pat. No. 8466137 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013	Oct 12, 2026	U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8466138 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013	Oct 12, 2026	U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8486925 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2013	Oct 12, 2026
Pat. No. 8729057 DP* Testosterone gel and method of use Claim Types: Composition Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014	Oct 12, 2026
Pat. No. 8741881 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2014	Oct 12, 2026	U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 8754070 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 16, 2014	Oct 12, 2026
Pat. No. 8759329 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 9, 2014	Oct 12, 2026

ABBVIE
TRICOR (TABLET) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Fibric Acid Derivatives == peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: ABBVIE NDA No.: 021656 Prod. No.: 001 RX (48MG); 002 RX (145MG)

Patents Expiration Patented Use

Pat. No. 7276249 DP* Nanoparticulate fibrate formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None Feb 21, 2023

Pat. No. 7320802 Methods of treatment using nanoparticulate fenofibrate compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None Feb 21, 2023 U-847: Adjunctive therapy to diet in adults to reduce LDL-c, triglycerides and Apo b, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V)

Patents	Expiration	Patented Use
Pat. No. 7276249 DP* Nanoparticulate fibrate formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: None	Feb 21, 2023
Pat. No. 7320802 Methods of treatment using nanoparticulate fenofibrate compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: None	Feb 21, 2023	U-847: Adjunctive therapy to diet in adults to reduce LDL-c, triglycerides and Apo b, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V)

ABBVIE
TRILIPIX (CAPSULE, DELAYED RELEASE) (ORAL) CHOLINE FENOFIBRATE [GENERIC AB]
NDA Applicant: ABBVIE NDA No.: 022224 Prod. No.: 001 RX (EQ 45MG FENOFIBRIC ACID); 002 RX (EQ 135MG FENOFIBRIC ACID)

Patents Expiration Patented Use

Pat. No. 7259186 DS* Salts of fenofibric acid and pharmaceutical formulations thereof
Claim Types: Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None Jan 7, 2025

Patents	Expiration	Patented Use
Pat. No. 7259186 DS* Salts of fenofibric acid and pharmaceutical formulations thereof Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None	Jan 7, 2025

ABBVIE
ZEMPLAR (SOLUTION) (INTRAVENOUS) PARICALCITOL [GENERIC AP]
Drug Classes: Metabolic Bone Disease Agents == vitamin D2 analog
NDA Applicant: ABBVIE NDA No.: 020819 Prod. No.: 001 RX (0.005MG/ML (0.005MG/ML)); 002 RX (0.002MG/ML (0.002MG/ML)); 003 RX (0.01MG/2ML (0.005MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) Oct 18, 2023

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Oct 18, 2023

ABBVIE
ZEMPLAR (CAPSULE) (ORAL) PARICALCITOL [GENERIC AB]
Drug Classes: Metabolic Bone Disease Agents == vitamin D2 analog
NDA Applicant: ABBVIE NDA No.: 021606 Prod. No.: 001 RX (1MCG); 002 RX (2MCG) NDA No.: 021606 Prod. No.: 003 DISC (4MCG)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Oct 18, 2023 ODE-125: Indicated in pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4 and ckd stage 5 in patients on hemodialysis or peritoneal dialysis

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Oct 18, 2023	ODE-125: Indicated in pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4 and ckd stage 5 in patients on hemodialysis or peritoneal dialysis

ABBVIE ENDOCRINE INC
LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC NDA No.: 020517 Prod. No.: 003 RX (45MG/VIAL)

Patents Expiration Patented Use

Pat. No. 8815801 DP* Controlled release composition and method of producing the same
Claim Types: Formulation
Pat. Sub. Date(s): 003: Mar 13, 2015 Jun 28, 2022

Pat. No. 8921326 DP* Sustained-release composition and method for producing the same
Claim Types: Formulation
Pat. Sub. Date(s): 003: Mar 13, 2015 Feb 5, 2031 U-1666: Palliative treatment of prostate cancer

Patents	Expiration	Patented Use
Pat. No. 8815801 DP* Controlled release composition and method of producing the same Claim Types: Formulation Pat. Sub. Date(s): 003: Mar 13, 2015	Jun 28, 2022
Pat. No. 8921326 DP* Sustained-release composition and method for producing the same Claim Types: Formulation Pat. Sub. Date(s): 003: Mar 13, 2015	Feb 5, 2031	U-1666: Palliative treatment of prostate cancer

ABBVIE INC
DUOPA (SUSPENSION) (ENTERAL) CARBIDOPA; LEVODOPA
Drug Classes: Antiparkinson Agents:Dopamine Precursors and/or L-Amino Acid Decarboxylase Inhibitors == Antiparkinson Agents:Antiparkinson Agents, Other == aromatic amino acid decarboxylation inhibitor
NDA Applicant: ABBVIE INC NDA No.: 203952 Prod. No.: 001 RX (4.63MG/ML;20MG/ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Jan 9, 2022 ODE-84: Treatment of motor fluctuations in patients with advanced Parkinson's disease

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Jan 9, 2022	ODE-84: Treatment of motor fluctuations in patients with advanced Parkinson's disease

ABBVIE INC
MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus (HCV) NS3/4A protease inhibitor == hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE INC NDA No.: 209394 Prod. No.: 001 RX (100MG;40MG)

Patents Expiration Patented Use

Pat. No. RE48923 DS* Crystal forms
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Mar 8, 2022 Nov 8, 2035 *PED

Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 29, 2017 Jul 19, 2032 *PED U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg

Pat. No. 8937150 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 29, 2017 Nov 18, 2032 *PED

Pat. No. 9321807 DS* Crystal forms
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Aug 29, 2017 Dec 5, 2035 *PED

Pat. No. 9586978 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 29, 2017 May 6, 2031 *PED U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg

Pat. No. 10028937 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 24, 2018 Dec 10, 2030 *PED U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg

Pat. No. 10039754 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018 Dec 10, 2030 *PED U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg

Pat. No. 10286029 Method for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 31, 2019 Sep 14, 2034 *PED U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg

Pat. No. 11246866 DP* Solid pharmaceutical compositions for treating HCV
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Mar 8, 2022 Dec 24, 2036 *PED

Exclusivity Expiration Exclusivity Description

Exclusivity Code: D - New Dosing Schedule Mar 26, 2023 PED D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 study

Exclusivity Code: M - Miscellaneous Aug 6, 2021 M-230: Revisions to the glecaprevir/pibrentasvir combination product prescribing information to include safety and efficacy data from the HCV/HIV-1 coinfection study M14-730 and from the liver and renal transplant study M13-596

Exclusivity Code: M - Miscellaneous Oct 10, 2023 PED M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infection

Exclusivity Code: NCE - New chemical entity Feb 3, 2023 PED

Exclusivity Code: NPP - New patient population Oct 30, 2022 PED

Exclusivity Code: ODE - Orphan drug exclusivity Oct 30, 2026 PED ODE-232: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)

Exclusivity Code: ODE - Orphan drug exclusivity Oct 30, 2026 PED ODE-233: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both

Exclusivity Code: ODE - Orphan drug exclusivity Dec 10, 2028 PED ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both

Patents	Expiration	Patented Use
Pat. No. RE48923 DS* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 8, 2022	Nov 8, 2035 *PED
Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 29, 2017	Jul 19, 2032 *PED	U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 8937150 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 29, 2017	Nov 18, 2032 *PED
Pat. No. 9321807 DS* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Aug 29, 2017	Dec 5, 2035 *PED
Pat. No. 9586978 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 29, 2017	May 6, 2031 *PED	U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 10028937 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 24, 2018	Dec 10, 2030 *PED	U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 10039754 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 6, 2018	Dec 10, 2030 *PED	U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 10286029 Method for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: May 31, 2019	Sep 14, 2034 *PED	U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 11246866 DP* Solid pharmaceutical compositions for treating HCV Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Mar 8, 2022	Dec 24, 2036 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	Mar 26, 2023 PED	D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 study
Exclusivity Code: M - Miscellaneous	Aug 6, 2021	M-230: Revisions to the glecaprevir/pibrentasvir combination product prescribing information to include safety and efficacy data from the HCV/HIV-1 coinfection study M14-730 and from the liver and renal transplant study M13-596
Exclusivity Code: M - Miscellaneous	Oct 10, 2023 PED	M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infection
Exclusivity Code: NCE - New chemical entity	Feb 3, 2023 PED
Exclusivity Code: NPP - New patient population	Oct 30, 2022 PED
Exclusivity Code: ODE - Orphan drug exclusivity	Oct 30, 2026 PED	ODE-232: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Exclusivity Code: ODE - Orphan drug exclusivity	Oct 30, 2026 PED	ODE-233: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both
Exclusivity Code: ODE - Orphan drug exclusivity	Dec 10, 2028 PED	ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both

ABBVIE INC
MAVYRET (PELLETS) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus (HCV) NS3/4A protease inhibitor == hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE INC NDA No.: 215110 Prod. No.: 001 RX (50MG;20MG/PACKET)

Patents Expiration Patented Use

Pat. No. RE48923 DS* Crystal forms
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Mar 8, 2022 Nov 8, 2035 *PED

Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021 Jul 19, 2032 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg

Pat. No. 8937150 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 8, 2021 Nov 18, 2032 *PED

Pat. No. 9321807 DS* DP* Crystal forms
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Jul 8, 2021 Dec 5, 2035 *PED

Pat. No. 9586978 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021 May 6, 2031 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg

Pat. No. 10028937 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021 Dec 10, 2030 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg

Pat. No. 10039754 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021 Dec 10, 2030 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg

Pat. No. 10286029 Method for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021 Sep 14, 2034 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg

Exclusivity Expiration Exclusivity Description

Exclusivity Code: D - New Dosing Schedule Mar 26, 2023 PED D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 study

Exclusivity Code: M - Miscellaneous Oct 10, 2023 PED M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infection

Exclusivity Code: NCE - New chemical entity Feb 3, 2023 PED

Exclusivity Code: ODE - Orphan drug exclusivity Dec 10, 2028 PED ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both

Patents	Expiration	Patented Use
Pat. No. RE48923 DS* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Mar 8, 2022	Nov 8, 2035 *PED
Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 8, 2021	Jul 19, 2032 *PED	U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Pat. No. 8937150 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 8, 2021	Nov 18, 2032 *PED
Pat. No. 9321807 DS* DP* Crystal forms Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Jul 8, 2021	Dec 5, 2035 *PED
Pat. No. 9586978 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021	May 6, 2031 *PED	U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Pat. No. 10028937 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021	Dec 10, 2030 *PED	U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Pat. No. 10039754 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021	Dec 10, 2030 *PED	U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Pat. No. 10286029 Method for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 8, 2021	Sep 14, 2034 *PED	U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	Mar 26, 2023 PED	D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 study
Exclusivity Code: M - Miscellaneous	Oct 10, 2023 PED	M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infection
Exclusivity Code: NCE - New chemical entity	Feb 3, 2023 PED
Exclusivity Code: ODE - Orphan drug exclusivity	Dec 10, 2028 PED	ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both

ABBVIE INC
ORIAHNN (COPACKAGED) (CAPSULE) (ORAL) ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary) == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE INC NDA No.: 213388 Prod. No.: 001 RX (EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE)

Patents Expiration Patented Use

Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jun 29, 2020 Sep 10, 2024

Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 29, 2020 Jul 6, 2024

Pat. No. 10881659 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 3, 2021 Mar 14, 2034 U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)

Pat. No. 11045470 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 27, 2021 Mar 14, 2034 U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Jul 23, 2023

Exclusivity Code: NP - New product May 29, 2023

Patents	Expiration	Patented Use
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 29, 2020	Sep 10, 2024
Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 29, 2020	Jul 6, 2024
Pat. No. 10881659 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 3, 2021	Mar 14, 2034	U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
Pat. No. 11045470 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 27, 2021	Mar 14, 2034	U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 23, 2023
Exclusivity Code: NP - New product	May 29, 2023

ABBVIE INC
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary) == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE INC NDA No.: 210450 Prod. No.: 001 RX (EQ 150MG BASE)

Patents Expiration Patented Use

Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 20, 2018 Sep 10, 2024

Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 20, 2018 Jul 6, 2024 U-2360: Management of moderate to severe pain associated with endometriosis

Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 20, 2018 Jul 6, 2024 U-2360: Management of moderate to severe pain associated with endometriosis

Pat. No. 10537572 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 19, 2020 Sep 1, 2036 U-2735: Management of moderate to severe pain associated with endometriosis using 150mg elagolix while co-administering rifampin

Pat. No. 10682351 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 15, 2020 Sep 1, 2036 U-2850: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix while co-administering ketoconazole

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Jul 23, 2023

Patents	Expiration	Patented Use
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 20, 2018	Sep 10, 2024
Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 20, 2018	Jul 6, 2024	U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 20, 2018	Jul 6, 2024	U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 10537572 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 19, 2020	Sep 1, 2036	U-2735: Management of moderate to severe pain associated with endometriosis using 150mg elagolix while co-administering rifampin
Pat. No. 10682351 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 15, 2020	Sep 1, 2036	U-2850: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix while co-administering ketoconazole
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 23, 2023

ABBVIE INC
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary) == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE INC NDA No.: 210450 Prod. No.: 002 RX (EQ 200MG BASE)

Patents Expiration Patented Use

Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Aug 20, 2018 Sep 10, 2024

Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Method of use
Pat. Sub. Date(s): 002: Aug 20, 2018 Jul 6, 2024 U-2360: Management of moderate to severe pain associated with endometriosis

Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Aug 20, 2018 Jul 6, 2024 U-2360: Management of moderate to severe pain associated with endometriosis

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Jul 23, 2023

Patents	Expiration	Patented Use
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Aug 20, 2018	Sep 10, 2024
Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 20, 2018	Jul 6, 2024	U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Aug 20, 2018	Jul 6, 2024	U-2360: Management of moderate to severe pain associated with endometriosis
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 23, 2023

ABBVIE INC
QULIPTA (TABLET) (ORAL) ATOGEPANT
NDA Applicant: ABBVIE INC NDA No.: 215206 Prod. No.: 001 RX (10MG); 002 RX (30MG); 003 RX (60MG)

Patents Expiration Patented Use

Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 26, 2021 Jul 19, 2032 U-3142: Preventive treatment of episodic migraine in adults

Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 26, 2021 Nov 10, 2031 U-3142: Preventive treatment of episodic migraine in adults

Pat. No. 9850246 DS* Process for making CGRP receptor antagonists
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Oct 26, 2021 Mar 13, 2033

Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 26, 2021 Jan 30, 2035

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Sep 28, 2026

Patents	Expiration	Patented Use
Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2021	Jul 19, 2032	U-3142: Preventive treatment of episodic migraine in adults
Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2021	Nov 10, 2031	U-3142: Preventive treatment of episodic migraine in adults
Pat. No. 9850246 DS* Process for making CGRP receptor antagonists Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Oct 26, 2021	Mar 13, 2033
Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 26, 2021	Jan 30, 2035
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Sep 28, 2026

ABBVIE INC
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: ABBVIE INC NDA No.: 211675 Prod. No.: 001 RX (15MG)

Patents Expiration Patented Use

Pat. No. RE47221 DS* Tricyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 001: Sep 13, 2019 Dec 1, 2030

Pat. No. 8962629 DS* Tricyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2019 Jan 15, 2031 U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers
U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers
U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers

Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process
Pat. Sub. Date(s): 001: Sep 13, 2019 Oct 17, 2036

Pat. No. 9963459 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpla]pyrrolo[2,3-e]-pyrazin-8-YL)-N-(2- ,2,2-Trifluoroethyl)pyrrol and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 13, 2019 Oct 17, 2036

Pat. No. 10519164 DP* Processes for the preparation of (3S,4R)-3,ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 29, 2020 Oct 17, 2036

Pat. No. 10597400 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2020 Oct 17, 2036 U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers

Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 001: May 18, 2021 Oct 17, 2036

Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 18, 2021 Oct 17, 2036

Pat. No. 10995095 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 10, 2022 Oct 17, 2036 U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable

Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Dec 17, 2021 Oct 17, 2036

Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 17, 2021 Oct 17, 2036

Exclusivity Expiration Exclusivity Description

Exclusivity Code: I - New Indication Dec 14, 2024 I-880: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers

Exclusivity Code: I - New Indication Jan 14, 2025 I-883: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable

Exclusivity Code: I - New Indication Mar 16, 2025 I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers

Exclusivity Code: NCE - New chemical entity Aug 16, 2024

Patents	Expiration	Patented Use
Pat. No. RE47221 DS* Tricyclic compounds Claim Types: Compound Pat. Sub. Date(s): 001: Sep 13, 2019	Dec 1, 2030
Pat. No. 8962629 DS* Tricyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 13, 2019	Jan 15, 2031	U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 001: Sep 13, 2019	Oct 17, 2036
Pat. No. 9963459 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpla]pyrrolo[2,3-e]-pyrazin-8-YL)-N-(2- ,2,2-Trifluoroethyl)pyrrol and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 13, 2019	Oct 17, 2036
Pat. No. 10519164 DP* Processes for the preparation of (3S,4R)-3,ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 29, 2020	Oct 17, 2036
Pat. No. 10597400 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2020	Oct 17, 2036	U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 001: May 18, 2021	Oct 17, 2036
Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 18, 2021	Oct 17, 2036
Pat. No. 10995095 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 10, 2022	Oct 17, 2036	U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable
Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Dec 17, 2021	Oct 17, 2036
Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2021	Oct 17, 2036
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Dec 14, 2024	I-880: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Code: I - New Indication	Jan 14, 2025	I-883: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable
Exclusivity Code: I - New Indication	Mar 16, 2025	I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Code: NCE - New chemical entity	Aug 16, 2024

ABBVIE INC
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: ABBVIE INC NDA No.: 211675 Prod. No.: 002 RX (30MG)

Patents Expiration Patented Use

Pat. No. RE47221 DS* Tricyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 002: Feb 10, 2022 Dec 1, 2030

Pat. No. 8962629 DS* Tricyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Feb 10, 2022 Jan 15, 2031 U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers

Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process
Pat. Sub. Date(s): 002: Feb 10, 2022 Oct 17, 2036

Pat. No. 10344036 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-#a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,- 2-trifluoroethyl)pyrrolidine-1-#carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 10, 2022 Oct 17, 2036

Pat. No. 10550126 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-A]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 10, 2022 Oct 17, 2036 U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable

Pat. No. 10730883 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation claimed by its inherent performace characteristics; Formulation
Pat. Sub. Date(s): 002: Feb 10, 2022 Oct 17, 2036

Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 002: Feb 10, 2022 Oct 17, 2036

Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 10, 2022 Oct 17, 2036

Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 002: Feb 10, 2022 Oct 17, 2036

Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 10, 2022 Oct 17, 2036

Exclusivity Expiration Exclusivity Description

Exclusivity Code: I - New Indication Jan 14, 2025 I-883: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable

Exclusivity Code: I - New Indication Mar 16, 2025 I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers

Exclusivity Code: NCE - New chemical entity Aug 16, 2024

Patents	Expiration	Patented Use
Pat. No. RE47221 DS* Tricyclic compounds Claim Types: Compound Pat. Sub. Date(s): 002: Feb 10, 2022	Dec 1, 2030
Pat. No. 8962629 DS* Tricyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 002: Feb 10, 2022	Jan 15, 2031	U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 002: Feb 10, 2022	Oct 17, 2036
Pat. No. 10344036 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-#a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,- 2-trifluoroethyl)pyrrolidine-1-#carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 10, 2022	Oct 17, 2036
Pat. No. 10550126 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-A]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 10, 2022	Oct 17, 2036	U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable
Pat. No. 10730883 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation claimed by its inherent performace characteristics; Formulation Pat. Sub. Date(s): 002: Feb 10, 2022	Oct 17, 2036
Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 002: Feb 10, 2022	Oct 17, 2036
Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 10, 2022	Oct 17, 2036
Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Feb 10, 2022	Oct 17, 2036
Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Feb 10, 2022	Oct 17, 2036
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jan 14, 2025	I-883: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable
Exclusivity Code: I - New Indication	Mar 16, 2025	I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Code: NCE - New chemical entity	Aug 16, 2024

Patents	Expiration	Patented Use
Pat. No. RE47221 DS* Tricyclic compounds Claim Types: Compound Pat. Sub. Date(s): 003: Apr 14, 2022	Dec 1, 2030
Pat. No. 8962629 DS* Tricyclic compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Apr 14, 2022	Jan 15, 2031	U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 003: Apr 14, 2022	Oct 17, 2036
Pat. No. 10202393 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-.alpha.]pyrrolo[2,3-e]-pyrazin-8-yl)-N-- (2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 003: Apr 14, 2022	Oct 17, 2036
Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 003: Apr 14, 2022	Oct 17, 2036
Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 003: Apr 14, 2022	Oct 17, 2036
Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Claim Types: Formulation Pat. Sub. Date(s): 003: Apr 14, 2022	Oct 17, 2036
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Mar 16, 2025	I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Code: NCE - New chemical entity	Aug 16, 2024

ABBVIE INC
TECHNIVIE (TABLET) (ORAL) OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == CYP3A inhibitor == HIV protease inhibitor
NDA Applicant: ABBVIE INC NDA No.: 207931 Prod. No.: 001 DISC (12.5MG;75MG;50MG)

Patents Expiration Patented Use

Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015 Feb 25, 2025 *PED

Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015 Feb 25, 2025 *PED

Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015 Oct 10, 2031 *PED

Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015 Sep 10, 2029 U-1638: Treatment of HCV infection using paritaprevir

Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015 Jun 9, 2031

Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015 Apr 13, 2032

Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015 Jun 10, 2030 U-1687: Treatment of HCV infection using ombitasvir

Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015 Apr 10, 2031 U-1638: Treatment of HCV infection using paritaprevir

Patents	Expiration	Patented Use
Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015	Feb 25, 2025 *PED
Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015	Feb 25, 2025 *PED
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 6, 2015	Oct 10, 2031 *PED
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 6, 2015	Sep 10, 2029	U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015	Jun 9, 2031
Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 6, 2015	Apr 13, 2032
Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2015	Jun 10, 2030	U-1687: Treatment of HCV infection using ombitasvir
Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2015	Apr 10, 2031	U-1638: Treatment of HCV infection using paritaprevir

ABBVIE INC
VENCLEXTA (TABLET) (ORAL) VENETOCLAX
Drug Classes: Antineoplastics:Molecular Target Inhibitors == BCL-2 inhibitor
NDA Applicant: ABBVIE INC NDA No.: 208573 Prod. No.: 001 RX (10MG); 002 RX (50MG); 003 RX (100MG)

Patents Expiration Patented Use

Pat. No. 8546399 DS* DP* Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: May 4, 2016 Jun 27, 2031

Pat. No. 8722657 DS* Salts and crystalline forms of an apoptosis-inducing agent
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Feb 13, 2020 Jan 29, 2032

Pat. No. 9174982 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 4, 2016 May 26, 2030 U-2323: Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy
U-2445: Treatment in combination with azacitidine or decitabine or low-dose cytarabine of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
U-2446: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy
U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Pat. No. 9539251 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 13, 2019 Sep 6, 2033 U-2538: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (Sll) in combination with a GA101 antibody such as obinutuzumab for one or more dosing periods, wherein the CLL or SLL is a CD20-expressing cancer

Pat. No. 10730873 DS* Salts and crystalline forms of an apoptosis-inducing agent
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Aug 17, 2020 Nov 21, 2031

Pat. No. 10993942 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Claim Types: Method of use; Dosaage regimen
Pat. Sub. Date(s): All strengths: May 24, 2021 Sep 6, 2033 U-3114: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up that includes a dose of 50 mg per day for 1 week followed by 100 mg per day for 1 week

Pat. No. 11110087 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 7, 2021 Sep 6, 2033 U-3222: Treatment of acute myeloid leukemia (AML) by orally administering venetoclax with azacitidine or decitabine or low-dose cytarabine in adults 75 years or older or having certain comorbidities according to a dose ramp-up including a 100 mg per day dose
U-3223: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up including a 100 mg per day dose

Exclusivity Expiration Exclusivity Description

Exclusivity Code: I - New Indication Nov 21, 2021 I-789: Venetoclax in combo with azacitidine or decitabine or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy

Exclusivity Code: I - New Indication May 15, 2022 I-795: Venetoclax in combination with obinutuzumab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma

Exclusivity Code: M - Miscellaneous Oct 16, 2023 M-265: Revisions to the labeling to include results from clinical study M15-656 (VIALE-A) and M16-043 (VIALE-C) to support PMR 3545-1 and PMR 3545-2

Exclusivity Code: ODE - Orphan drug exclusivity Apr 11, 2023 ODE-114: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy

Exclusivity Code: ODE - Orphan drug exclusivity Jun 8, 2025 ODE-185: Indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy

Exclusivity Code: ODE - Orphan drug exclusivity Nov 21, 2025 ODE-211: Indicated in combo with azacitidine, or decitabine, or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy

Exclusivity Code: ODE - Orphan drug exclusivity May 15, 2026 ODE-239: Treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Patents	Expiration	Patented Use
Pat. No. 8546399 DS* DP* Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 4, 2016	Jun 27, 2031
Pat. No. 8722657 DS* Salts and crystalline forms of an apoptosis-inducing agent Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Feb 13, 2020	Jan 29, 2032
Pat. No. 9174982 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 4, 2016	May 26, 2030	U-2323: Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy U-2445: Treatment in combination with azacitidine or decitabine or low-dose cytarabine of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy U-2446: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Pat. No. 9539251 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2019	Sep 6, 2033	U-2538: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (Sll) in combination with a GA101 antibody such as obinutuzumab for one or more dosing periods, wherein the CLL or SLL is a CD20-expressing cancer
Pat. No. 10730873 DS* Salts and crystalline forms of an apoptosis-inducing agent Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Aug 17, 2020	Nov 21, 2031
Pat. No. 10993942 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): All strengths: May 24, 2021	Sep 6, 2033	U-3114: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up that includes a dose of 50 mg per day for 1 week followed by 100 mg per day for 1 week
Pat. No. 11110087 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2021	Sep 6, 2033	U-3222: Treatment of acute myeloid leukemia (AML) by orally administering venetoclax with azacitidine or decitabine or low-dose cytarabine in adults 75 years or older or having certain comorbidities according to a dose ramp-up including a 100 mg per day dose U-3223: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up including a 100 mg per day dose
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Nov 21, 2021	I-789: Venetoclax in combo with azacitidine or decitabine or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
Exclusivity Code: I - New Indication	May 15, 2022	I-795: Venetoclax in combination with obinutuzumab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
Exclusivity Code: M - Miscellaneous	Oct 16, 2023	M-265: Revisions to the labeling to include results from clinical study M15-656 (VIALE-A) and M16-043 (VIALE-C) to support PMR 3545-1 and PMR 3545-2
Exclusivity Code: ODE - Orphan drug exclusivity	Apr 11, 2023	ODE-114: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy
Exclusivity Code: ODE - Orphan drug exclusivity	Jun 8, 2025	ODE-185: Indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy
Exclusivity Code: ODE - Orphan drug exclusivity	Nov 21, 2025	ODE-211: Indicated in combo with azacitidine, or decitabine, or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivity	May 15, 2026	ODE-239: Treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

ABBVIE INC
VIEKIRA PAK (COPACKAGED) (TABLET) (ORAL) DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor
NDA Applicant: ABBVIE INC NDA No.: 206619 Prod. No.: 001 DISC (EQ 250MG BASE;12.5MG, 75MG, 50MG)

Patents Expiration Patented Use

Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015 May 17, 2029 U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.

Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 15, 2015 Aug 25, 2024

Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 15, 2015 Aug 25, 2024

Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015 Apr 10, 2031

Pat. No. 8466159 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2015 Sep 4, 2032 U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.

Pat. No. 8492386 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2015 Sep 4, 2032 U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin

Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Jan 15, 2015 Sep 17, 2028 U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.

Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015 Sep 10, 2029 U-1638: Treatment of HCV infection using paritaprevir

Pat. No. 8680106 Methods for treating HCV
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015 Sep 4, 2032 U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.

Pat. No. 8685984 Methods for treating HCV
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015 Sep 4, 2032 U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin

Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 15, 2015 Jun 9, 2031

Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015 Apr 13, 2032

Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 6, 2015 Jun 10, 2030 U-1687: Treatment of HCV infection using ombitasvir

Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 1, 2015 Apr 10, 2031 U-1638: Treatment of HCV infection using paritaprevir

Pat. No. 9139536 Anti-infective agents and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 21, 2015 Nov 9, 2028 U-1753: Treatment of HCV infection using dasabuvir

Pat. No. 9629841 DP* Formulations of pyrimidinedione derivative compounds
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Jun 16, 2017 Oct 18, 2033 U-1753: Treatment of HCV infection using dasabuvir

Pat. No. 10201542 DP* Formulations of pyrimidinedione derivative compounds
Claim Types: Formulation; Method of use; Process; Method of improving a treatment
Pat. Sub. Date(s): 001: Mar 14, 2019 Oct 18, 2033 U-1753: Treatment of HCV infection using dasabuvir

Patents	Expiration	Patented Use
Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015	May 17, 2029	U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015	Aug 25, 2024
Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015	Aug 25, 2024
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015	Apr 10, 2031
Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015	Sep 4, 2032	U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015	Sep 4, 2032	U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 15, 2015	Sep 17, 2028	U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015	Sep 10, 2029	U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015	Sep 4, 2032	U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015	Sep 4, 2032	U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015	Jun 9, 2031
Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015	Apr 13, 2032
Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: May 6, 2015	Jun 10, 2030	U-1687: Treatment of HCV infection using ombitasvir
Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 1, 2015	Apr 10, 2031	U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2015	Nov 9, 2028	U-1753: Treatment of HCV infection using dasabuvir
Pat. No. 9629841 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jun 16, 2017	Oct 18, 2033	U-1753: Treatment of HCV infection using dasabuvir
Pat. No. 10201542 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Formulation; Method of use; Process; Method of improving a treatment Pat. Sub. Date(s): 001: Mar 14, 2019	Oct 18, 2033	U-1753: Treatment of HCV infection using dasabuvir

ABBVIE INC
VIEKIRA XR (TABLET, EXTENDED RELEASE) (ORAL) DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor == hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == CYP3A inhibitor == HIV protease inhibitor
NDA Applicant: ABBVIE INC NDA No.: 208624 Prod. No.: 001 DISC (EQ 200MG BASE;8.33MG;50MG;33.33MG)

Patents Expiration Patented Use

Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016 May 17, 2029 U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.

Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 17, 2016 Aug 25, 2024

Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 17, 2016 Aug 25, 2024

Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 17, 2016 Apr 10, 2031

Pat. No. 8466159 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 17, 2016 Sep 4, 2032 U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.

Pat. No. 8492386 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 17, 2016 Sep 4, 2032 U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin

Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Aug 17, 2016 Sep 17, 2028 U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.

Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016 Sep 10, 2029 U-1638: Treatment of HCV infection using paritaprevir

Pat. No. 8680106 Methods for treating HCV
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016 Sep 4, 2032 U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.

Pat. No. 8685984 Methods for treating HCV
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016 Sep 4, 2032 U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin

Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 17, 2016 Jun 9, 2031

Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 17, 2016 Apr 13, 2032

Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016 Jun 10, 2030 U-1687: Treatment of HCV infection using ombitasvir

Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016 Apr 10, 2031 U-1638: Treatment of HCV infection using paritaprevir

Pat. No. 9139536 Anti-infective agents and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016 Nov 9, 2028 U-1753: Treatment of HCV infection using dasabuvir

Pat. No. 9333204 DP* Solid antiviral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016 Jan 2, 2035 U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination

Pat. No. 9744170 DP* Solid antiviral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 27, 2017 Jan 2, 2035 U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination

Pat. No. 10105365 DP* Solid antiviral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018 Jan 2, 2035 U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination

Pat. No. 10201541 DP* Compositions and methods for treating HCV
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 14, 2019 May 17, 2032

Pat. No. 10201584 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 14, 2019 May 17, 2032 U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination

Patents	Expiration	Patented Use
Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016	May 17, 2029	U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016	Aug 25, 2024
Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016	Aug 25, 2024
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016	Apr 10, 2031
Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016	Sep 4, 2032	U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016	Sep 4, 2032	U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Aug 17, 2016	Sep 17, 2028	U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016	Sep 10, 2029	U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016	Sep 4, 2032	U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016	Sep 4, 2032	U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016	Jun 9, 2031
Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016	Apr 13, 2032
Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016	Jun 10, 2030	U-1687: Treatment of HCV infection using ombitasvir
Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016	Apr 10, 2031	U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016	Nov 9, 2028	U-1753: Treatment of HCV infection using dasabuvir
Pat. No. 9333204 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016	Jan 2, 2035	U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
Pat. No. 9744170 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 27, 2017	Jan 2, 2035	U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
Pat. No. 10105365 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 20, 2018	Jan 2, 2035	U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
Pat. No. 10201541 DP* Compositions and methods for treating HCV Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2019	May 17, 2032
Pat. No. 10201584 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2019	May 17, 2032	U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination

ABBVIE INC
VUITY (SOLUTION) (OPHTHALMIC) PILOCARPINE HYDROCHLORIDE
Drug Classes: Dental and Oral Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == cholinergic agonist
NDA Applicant: ABBVIE INC NDA No.: 214028 Prod. No.: 001 RX (1.25%)

Patents Expiration Patented Use

Pat. No. 10610518 Presbyopia treatments
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 24, 2021 Apr 24, 2039 U-3252: Use of VUITY for the treatment of presbyopia in adults

Pat. No. 11285134 Presbyopia treatments
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2022 Apr 24, 2039 U-3252: Use of VUITY for the treatment of presbyopia in adults

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NP - New product Oct 28, 2024

Patents	Expiration	Patented Use
Pat. No. 10610518 Presbyopia treatments Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 24, 2021	Apr 24, 2039	U-3252: Use of VUITY for the treatment of presbyopia in adults
Pat. No. 11285134 Presbyopia treatments Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2022	Apr 24, 2039	U-3252: Use of VUITY for the treatment of presbyopia in adults
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Oct 28, 2024

ABRAXIS BIOSCIENCE
ABRAXANE (POWDER) (INTRAVENOUS) PACLITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: ABRAXIS BIOSCIENCE NDA No.: 021660 Prod. No.: 001 RX (100MG/VIAL)

Patents Expiration Patented Use

Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2013 Aug 21, 2026 *PED U-1434: Treatment of pancreatic cancer

Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 12, 2010 Apr 27, 2025 *PED U-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer

Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2011 Jun 9, 2024 *PED U-1117: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer

Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012 Feb 13, 2027 *PED U-1290: Treatment of lung cancer

Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Mar 27, 2012 Jun 9, 2024 *PED U-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer

Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012 Aug 21, 2026 *PED U-1290: Treatment of lung cancer

Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2012 Jun 9, 2024 *PED U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer

Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 18, 2015 Aug 21, 2026 *PED U-1434: Treatment of pancreatic cancer

Pat. No. 9393318 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2016 Sep 4, 2032 *PED U-1290: Treatment of lung cancer

Pat. No. 9511046 Methods of treating pancreatic cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2016 Jul 12, 2034 *PED U-1434: Treatment of pancreatic cancer

Pat. No. 9597409 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2017 Sep 4, 2032 *PED U-1290: Treatment of lung cancer

Exclusivity Expiration Exclusivity Description

Exclusivity Code: M - Miscellaneous Jun 6, 2023 PED M-14: Additional clinical trial information added to pediatric use subsection

Patents	Expiration	Patented Use
Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2013	Aug 21, 2026 *PED	U-1434: Treatment of pancreatic cancer
Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 12, 2010	Apr 27, 2025 *PED	U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer
Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 15, 2011	Jun 9, 2024 *PED	U-1117: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer
Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012	Feb 13, 2027 *PED	U-1290: Treatment of lung cancer
Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Drug in a container; Method of administration Pat. Sub. Date(s): 001: Mar 27, 2012	Jun 9, 2024 *PED	U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer
Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012	Aug 21, 2026 *PED	U-1290: Treatment of lung cancer
Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2012	Jun 9, 2024 *PED	U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer
Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2015	Aug 21, 2026 *PED	U-1434: Treatment of pancreatic cancer
Pat. No. 9393318 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2016	Sep 4, 2032 *PED	U-1290: Treatment of lung cancer
Pat. No. 9511046 Methods of treating pancreatic cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2016	Jul 12, 2034 *PED	U-1434: Treatment of pancreatic cancer
Pat. No. 9597409 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2017	Sep 4, 2032 *PED	U-1290: Treatment of lung cancer
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Jun 6, 2023 PED	M-14: Additional clinical trial information added to pediatric use subsection

ACACIA
BARHEMSYS (SOLUTION) (INTRAVENOUS) AMISULPRIDE
Drug Classes: Antiemetics:Antiemetics, Other == dopamine-2 (D2) antagonist
NDA Applicant: ACACIA NDA No.: 209510 Prod. No.: 001 RX (5MG/2ML (2.5MG/ML)); 002 RX (10MG/4ML (2.5MG/ML))

Patents Expiration Patented Use

Pat. No. 9084765 Use of amisulpride as an anti-emetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022 Mar 10, 2031 U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting

Pat. No. 9545426 Use of amisulpride as an anti-emetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022 Mar 10, 2031 U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting

Pat. No. 9889118 Use of amisulpride as an anti-emetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022 Mar 10, 2031 U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting

Pat. No. 10525033 DP* Use of amisulpride as an anti-emetic
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022 Mar 10, 2031

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Feb 26, 2025

Patents	Expiration	Patented Use
Pat. No. 9084765 Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022	Mar 10, 2031	U-1744: Prevention of post-operative nausea and vomiting U-2754: Treatment of post-operative nausea and vomiting
Pat. No. 9545426 Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022	Mar 10, 2031	U-1744: Prevention of post-operative nausea and vomiting U-2754: Treatment of post-operative nausea and vomiting
Pat. No. 9889118 Use of amisulpride as an anti-emetic Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022	Mar 10, 2031	U-1744: Prevention of post-operative nausea and vomiting U-2754: Treatment of post-operative nausea and vomiting
Pat. No. 10525033 DP* Use of amisulpride as an anti-emetic Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022	Mar 10, 2031
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Feb 26, 2025

ACACIA
BYFAVO (POWDER) (INTRAVENOUS) REMIMAZOLAM BESYLATE
NDA Applicant: ACACIA NDA No.: 212295 Prod. No.: 001 RX (EQ 20MG BASE/VIAL)

Patents Expiration Patented Use

Pat. No. 9561236 Dosing regimen for sedation with CNS 7056 (Remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020 Apr 30, 2033 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Pat. No. 9737547 Dosing regimen for sedation with CNS 7056 (Remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020 Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Pat. No. 9777007 DP* Short-acting benzodiazepine salts and their polymorphic forms
Claim Types: Composition
Pat. Sub. Date(s): 001: Oct 23, 2020 Jul 10, 2027

Pat. No. 9827251 Dosing regimen for sedation with CNS 7056 (remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020 Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Pat. No. 9914738 DP* Short-acting benzodiazepine salts and their polymorphic forms
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Oct 23, 2020 Jul 10, 2027

Pat. No. 10052334 Dosing regimen for sedation with CNS 7056 (remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020 Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Pat. No. 10195210 Dosing regimen for sedation with CNS 7056 (Remimazolam)
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): 001: Oct 23, 2020 Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Pat. No. 10342800 Dosing regimen for sedation with CNS 7056 (Remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020 Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Pat. No. 10472365 Short-acting benzodiazepine salts and their polymorphic forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020 Jul 10, 2027 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Pat. No. 10722522 Dosing regimen for sedation with CNS 7056 (remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020 Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Oct 6, 2025

Patents	Expiration	Patented Use
Pat. No. 9561236 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020	Apr 30, 2033	U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 9737547 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020	Nov 7, 2031	U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 9777007 DP* Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Composition Pat. Sub. Date(s): 001: Oct 23, 2020	Jul 10, 2027
Pat. No. 9827251 Dosing regimen for sedation with CNS 7056 (remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020	Nov 7, 2031	U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 9914738 DP* Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Oct 23, 2020	Jul 10, 2027
Pat. No. 10052334 Dosing regimen for sedation with CNS 7056 (remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020	Nov 7, 2031	U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 10195210 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Oct 23, 2020	Nov 7, 2031	U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 10342800 Dosing regimen for sedation with CNS 7056 (Remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020	Nov 7, 2031	U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 10472365 Short-acting benzodiazepine salts and their polymorphic forms Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020	Jul 10, 2027	U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 10722522 Dosing regimen for sedation with CNS 7056 (remimazolam) Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 23, 2020	Nov 7, 2031	U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Oct 6, 2025

ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 207318 Prod. No.: 001 DISC (EQ 17MG BASE)

Patents Expiration Patented Use

Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: May 25, 2016 Apr 29, 2030

Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 25, 2016 Aug 24, 2026 U-1844: Treatment of Parkinson's disease psychosis

Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 001: May 25, 2016 Jun 3, 2028

Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 25, 2016 Sep 26, 2025

Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2016 Jan 15, 2024 U-1845: Treatment of psychosis or a symptom thereof

Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2016 Jan 15, 2024 U-1846: Treatment of a neurodegenerative disease or a symptom thereof

Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 14, 2017 Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 4, 2017 Jul 27, 2022 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2018 Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Patents	Expiration	Patented Use
Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: May 25, 2016	Apr 29, 2030
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 25, 2016	Aug 24, 2026	U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: May 25, 2016	Jun 3, 2028
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 25, 2016	Sep 26, 2025
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2016	Jan 15, 2024	U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2016	Jan 15, 2024	U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2017	Jan 15, 2024	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 4, 2017	Jul 27, 2022	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2018	Jan 15, 2024	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 207318 Prod. No.: 002 RX (EQ 10MG BASE)

Patents Expiration Patented Use

Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Jul 25, 2018 Apr 29, 2030

Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Jul 25, 2018 Aug 24, 2026 U-1844: Treatment of Parkinson's disease psychosis

Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 002: Jul 25, 2018 Jun 3, 2028

Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: Jul 25, 2018 Sep 26, 2025

Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018 Jan 15, 2024 U-1845: Treatment of psychosis or a symptom thereof

Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018 Jan 15, 2024 U-1846: Treatment of a neurodegenerative disease or a symptom thereof

Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018 Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018 Jul 27, 2022 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018 Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pat. No. 10517860 Combination of pimavanserin and cytochrome P450 modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 10, 2020 Mar 23, 2037 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pat. No. 10953000 Combination of pimavanserin and cytochrome P450 modulators
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Mar 30, 2021 Mar 23, 2037 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Patents	Expiration	Patented Use
Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Composition; Formulation Pat. Sub. Date(s): 002: Jul 25, 2018	Apr 29, 2030
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Jul 25, 2018	Aug 24, 2026	U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 002: Jul 25, 2018	Jun 3, 2028
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Jul 25, 2018	Sep 26, 2025
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018	Jan 15, 2024	U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018	Jan 15, 2024	U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018	Jan 15, 2024	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018	Jul 27, 2022	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018	Jan 15, 2024	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10517860 Combination of pimavanserin and cytochrome P450 modulators Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 10, 2020	Mar 23, 2037	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10953000 Combination of pimavanserin and cytochrome P450 modulators Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Mar 30, 2021	Mar 23, 2037	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

ACADIA PHARMS INC
NUPLAZID (CAPSULE) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC NDA No.: 210793 Prod. No.: 001 RX (EQ 34MG BASE)

Patents Expiration Patented Use

Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Jul 25, 2018 Apr 29, 2030

Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jul 25, 2018 Aug 24, 2026 U-1844: Treatment of Parkinson's disease psychosis

Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 001: Jul 25, 2018 Jun 3, 2028

Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 25, 2018 Sep 26, 2025

Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018 Jan 15, 2024 U-1845: Treatment of psychosis or a symptom thereof

Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018 Jan 15, 2024 U-1846: Treatment of a neurodegenerative disease or a symptom thereof

Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018 Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018 Jul 27, 2022 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018 Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Pat. No. 10449185 DP* Formulations of pimavanserin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 1, 2019 Aug 27, 2038

Pat. No. 10646480 DP* Formulations of pimavanserin
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 15, 2020 Aug 27, 2038

Pat. No. 10849891 DP* Formulations of pimavanserin
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 11, 2020 Aug 27, 2038 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

Patents	Expiration	Patented Use
Pat. No. 7601740 DS* DP* Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Jul 25, 2018	Apr 29, 2030
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jul 25, 2018	Aug 24, 2026	U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: Jul 25, 2018	Jun 3, 2028
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 25, 2018	Sep 26, 2025
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018	Jan 15, 2024	U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018	Jan 15, 2024	U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018	Jan 15, 2024	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018	Jul 27, 2022	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018	Jan 15, 2024	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10449185 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2019	Aug 27, 2038
Pat. No. 10646480 DP* Formulations of pimavanserin Claim Types: Formulation Pat. Sub. Date(s): 001: May 15, 2020	Aug 27, 2038
Pat. No. 10849891 DP* Formulations of pimavanserin Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 11, 2020	Aug 27, 2038	U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

ACCORD
CAMCEVI KIT (EMULSION) (SUBCUTANEOUS) LEUPROLIDE MESYLATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ACCORD NDA No.: 211488 Prod. No.: 001 RX (EQ 42MG BASE)

Patents Expiration Patented Use

Pat. No. 9572857 DP* Pharmaceutical compositions with enhanced stability
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 15, 2021 Jan 16, 2027

Pat. No. 9744207 DP* Pharmaceutical compositions with enhanced stability
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 15, 2021 Jan 16, 2027

Pat. No. 10646572 DP* Pharmaceutical compositions with enhanced stability
Claim Types: Formulation; Kit; Process
Pat. Sub. Date(s): 001: Jul 15, 2021 Jan 16, 2027

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NP - New product May 25, 2024

Patents	Expiration	Patented Use
Pat. No. 9572857 DP* Pharmaceutical compositions with enhanced stability Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 15, 2021	Jan 16, 2027
Pat. No. 9744207 DP* Pharmaceutical compositions with enhanced stability Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 15, 2021	Jan 16, 2027
Pat. No. 10646572 DP* Pharmaceutical compositions with enhanced stability Claim Types: Formulation; Kit; Process Pat. Sub. Date(s): 001: Jul 15, 2021	Jan 16, 2027
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	May 25, 2024

ACCORD HLTHCARE
ATROPINE SULFATE (SOLUTION) (INTRAVENOUS) ATROPINE SULFATE [GENERIC AP]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: ACCORD HLTHCARE NDA No.: 212868 Prod. No.: 001 RX (0.25MG/5ML (0.05MG/ML)); 002 RX (0.5MG/5ML (0.1MG/ML)); 003 RX (1MG/10ML (0.1MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Code: CGT - Competitive generic therapy Jan 26, 2022

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: CGT - Competitive generic therapy	Jan 26, 2022

ACCORD HLTHCARE
ATROPINE SULFATE (SOLUTION) (INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL) ATROPINE SULFATE [GENERIC AP]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: ACCORD HLTHCARE NDA No.: 213424 Prod. No.: 001 RX (8MG/20ML (0.4MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Code: CGT - Competitive generic therapy Sep 21, 2021

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: CGT - Competitive generic therapy	Sep 21, 2021

ACELRX PHARMS
DSUVIA (TABLET) (SUBLINGUAL) SUFENTANIL CITRATE
Drug Classes: opioid agonist
NDA Applicant: ACELRX PHARMS NDA No.: 209128 Prod. No.: 001 RX (EQ 0.03MG BASE)

Patents Expiration Patented Use

Pat. No. 8202535 Small-volume oral transmucosal dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2018 Oct 22, 2030 U-1351: Treatment of acute pain

Pat. No. 8226978 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027 U-1351: Treatment of acute pain

Pat. No. 8231900 DP* Small-volume oral transmucosal dosage
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027

Pat. No. 8252328 DP* Bioadhesive drug formulations for oral transmucosal delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027

Pat. No. 8252329 DP* Bioadhesive drug formulations for oral transmucosal delivery
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027

Pat. No. 8535714 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027 U-1351: Treatment of acute pain

Pat. No. 8574189 DP* Storage and dispensing devices for administration of oral transmucosal dosage forms
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 28, 2018 Mar 16, 2030

Pat. No. 8778393 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027 U-1351: Treatment of acute pain

Pat. No. 8778394 Small-volume oral transmucosal dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027 U-1351: Treatment of acute pain

Pat. No. 8865211 Bioadhesive drug formulations for oral transmucosal delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027 U-1351: Treatment of acute pain

Pat. No. 8865743 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2018 Oct 22, 2030 U-1351: Treatment of acute pain

Pat. No. 8945592 DP* Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same
Claim Types: Drug in a container?; Method of reducing drug degration?
Pat. Sub. Date(s): 001: Nov 28, 2018 Jul 29, 2031

Pat. No. 9320710 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027 U-1351: Treatment of acute pain

Pat. No. 9744129 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 28, 2018 Jan 5, 2027

Pat. No. 10245228 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 19, 2019 Jan 5, 2027 U-1351: Treatment of acute pain

Pat. No. 10342762 DP* Small-volume oral transmucosal dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 23, 2019 Jan 5, 2027

Pat. No. 10507180 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Claim Types: Formulation; Device; Method of use
Pat. Sub. Date(s): 001: Jan 9, 2020 Jan 5, 2027 U-1351: Treatment of acute pain

Pat. No. 10896751 DP* Storage and dispensing devices for administration of oral transmucosal dosage forms
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 2, 2021 Mar 16, 2030

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NP - New product Nov 2, 2021

Patents	Expiration	Patented Use
Pat. No. 8202535 Small-volume oral transmucosal dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018	Oct 22, 2030	U-1351: Treatment of acute pain
Pat. No. 8226978 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027	U-1351: Treatment of acute pain
Pat. No. 8231900 DP* Small-volume oral transmucosal dosage Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027
Pat. No. 8252328 DP* Bioadhesive drug formulations for oral transmucosal delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027
Pat. No. 8252329 DP* Bioadhesive drug formulations for oral transmucosal delivery Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027
Pat. No. 8535714 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027	U-1351: Treatment of acute pain
Pat. No. 8574189 DP* Storage and dispensing devices for administration of oral transmucosal dosage forms Claim Types: Device Pat. Sub. Date(s): 001: Nov 28, 2018	Mar 16, 2030
Pat. No. 8778393 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027	U-1351: Treatment of acute pain
Pat. No. 8778394 Small-volume oral transmucosal dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027	U-1351: Treatment of acute pain
Pat. No. 8865211 Bioadhesive drug formulations for oral transmucosal delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027	U-1351: Treatment of acute pain
Pat. No. 8865743 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018	Oct 22, 2030	U-1351: Treatment of acute pain
Pat. No. 8945592 DP* Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same Claim Types: Drug in a container?; Method of reducing drug degration? Pat. Sub. Date(s): 001: Nov 28, 2018	Jul 29, 2031
Pat. No. 9320710 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027	U-1351: Treatment of acute pain
Pat. No. 9744129 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2018	Jan 5, 2027
Pat. No. 10245228 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 19, 2019	Jan 5, 2027	U-1351: Treatment of acute pain
Pat. No. 10342762 DP* Small-volume oral transmucosal dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 23, 2019	Jan 5, 2027
Pat. No. 10507180 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Device; Method of use Pat. Sub. Date(s): 001: Jan 9, 2020	Jan 5, 2027	U-1351: Treatment of acute pain
Pat. No. 10896751 DP* Storage and dispensing devices for administration of oral transmucosal dosage forms Claim Types: Device Pat. Sub. Date(s): 001: Feb 2, 2021	Mar 16, 2030
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Nov 2, 2021

ACERUS
NATESTO (GEL, METERED) (NASAL) TESTOSTERONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ACERUS NDA No.: 205488 Prod. No.: 001 RX (5.5MG/0.122GM ACTUATION)

Patents Expiration Patented Use

Pat. No. 8574622 DP* Controlled release delivery system for nasal applications
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 26, 2014 Feb 4, 2024

Pat. No. 8784869 DP* Controlled release delivery system for nasal applications and methods of treatment
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 20, 2014 Feb 4, 2024

Pat. No. 8784882 DP* Controlled release delivery system for nasal applications and method of treatment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 20, 2014 Feb 4, 2024 U-1557: A method of testosterone replacement therapy comprising the step of nasally administering to a patient in need of such treatment an effective amount of testosterone gel formulation.

Pat. No. 8877230 Controlled release delivery system for nasal applications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 3, 2014 Feb 4, 2024 U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone

Pat. No. 11090312 Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Sep 10, 2021 Mar 17, 2034 U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone

Patents	Expiration	Patented Use
Pat. No. 8574622 DP* Controlled release delivery system for nasal applications Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 26, 2014	Feb 4, 2024
Pat. No. 8784869 DP* Controlled release delivery system for nasal applications and methods of treatment Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 20, 2014	Feb 4, 2024
Pat. No. 8784882 DP* Controlled release delivery system for nasal applications and method of treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 20, 2014	Feb 4, 2024	U-1557: A method of testosterone replacement therapy comprising the step of nasally administering to a patient in need of such treatment an effective amount of testosterone gel formulation.
Pat. No. 8877230 Controlled release delivery system for nasal applications Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2014	Feb 4, 2024	U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone
Pat. No. 11090312 Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Sep 10, 2021	Mar 17, 2034	U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone

ACLARIS
ESKATA (SOLUTION) (TOPICAL) HYDROGEN PEROXIDE
NDA Applicant: ACLARIS NDA No.: 209305 Prod. No.: 001 DISC (40%)

Patents Expiration Patented Use

Pat. No. 7381427 Seborrheic keratosis treatment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 3, 2018 Jun 8, 2022 U-2205: Treatment of seborrheic keratoses that are raised

Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 3, 2018 Jul 4, 2035 U-2205: Treatment of seborrheic keratoses that are raised

Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 18, 2018 Apr 21, 2035 U-2205: Treatment of seborrheic keratoses that are raised

Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018 Apr 21, 2035 U-2205: Treatment of seborrheic keratoses that are raised

Pat. No. 10493103 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2020 Apr 21, 2035

Pat. No. 10729720 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 11, 2020 Apr 21, 2035

Patents	Expiration	Patented Use
Pat. No. 7381427 Seborrheic keratosis treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 3, 2018	Jun 8, 2022	U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 3, 2018	Jul 4, 2035	U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 18, 2018	Apr 21, 2035	U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 25, 2018	Apr 21, 2035	U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 10493103 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device Pat. Sub. Date(s): 001: Jan 21, 2020	Apr 21, 2035
Pat. No. 10729720 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 11, 2020	Apr 21, 2035

ACORDA
INBRIJA (POWDER) (INHALATION) LEVODOPA
Drug Classes: Antiparkinson Agents:Dopamine Precursors and/or L-Amino Acid Decarboxylase Inhibitors == aromatic amino acid
NDA Applicant: ACORDA NDA No.: 209184 Prod. No.: 001 RX (42MG)

Patents Expiration Patented Use

Pat. No. RE43711 Pulmonary delivery for levodopa
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019 Feb 3, 2029 U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles

Pat. No. 7182961 DP* Particulate compositions for pulmonary delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019 Feb 22, 2024

Pat. No. 7384649 DP* Particulate compositions for pulmonary delivery
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 18, 2019 Nov 20, 2022

Pat. No. 8404276 Pulmonary delivery for levodopa
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019 Mar 19, 2023 U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles

Pat. No. 8545878 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019 Nov 16, 2032

Pat. No. 8586093 Pulmonary delivery for levodopa
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019 Mar 19, 2023 U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles

Pat. No. 8685442 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019 Nov 16, 2032

Pat. No. 8945612 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019 Nov 16, 2032

Pat. No. 9155699 DP* Pulmonary delivery for levodopa
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019 Mar 19, 2023

Pat. No. 9393210 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019 Nov 16, 2032

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NP - New product Dec 21, 2021

Patents	Expiration	Patented Use
Pat. No. RE43711 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019	Feb 3, 2029	U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 7182961 DP* Particulate compositions for pulmonary delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019	Feb 22, 2024
Pat. No. 7384649 DP* Particulate compositions for pulmonary delivery Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 18, 2019	Nov 20, 2022
Pat. No. 8404276 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019	Mar 19, 2023	U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 8545878 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019	Nov 16, 2032
Pat. No. 8586093 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019	Mar 19, 2023	U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 8685442 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019	Nov 16, 2032
Pat. No. 8945612 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019	Nov 16, 2032
Pat. No. 9155699 DP* Pulmonary delivery for levodopa Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019	Mar 19, 2023
Pat. No. 9393210 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019	Nov 16, 2032
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Dec 21, 2021

ACROTECH
BELEODAQ (POWDER) (INTRAVENOUS) BELINOSTAT
Drug Classes: Antineoplastics:Molecular Target Inhibitors == histone deacetylase (HDAC) inhibitor
NDA Applicant: ACROTECH NDA No.: 206256 Prod. No.: 001 RX (500MG/VIAL)

Patents Expiration Patented Use

Pat. No. 6888027 DS* DP* Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 1, 2014 Aug 10, 2026 U-1544: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Pat. No. 8835501 DP* Pharmaceutical formulations of HDAC inhibitors
Claim Types: Formulation; Drug in a container; Kit
Pat. Sub. Date(s): 001: Oct 9, 2014 Oct 27, 2027

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Jul 3, 2021 ODE-68: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

Patents	Expiration	Patented Use
Pat. No. 6888027 DS* DP* Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 1, 2014	Aug 10, 2026	U-1544: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Pat. No. 8835501 DP* Pharmaceutical formulations of HDAC inhibitors Claim Types: Formulation; Drug in a container; Kit Pat. Sub. Date(s): 001: Oct 9, 2014	Oct 27, 2027
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Jul 3, 2021	ODE-68: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

ACROTECH
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ACROTECH NDA No.: 207155 Prod. No.: 001 RX (EQ 50MG BASE/VIAL)

Patents Expiration Patented Use

Pat. No. 8410077 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Composition; Compound; Product-by-process; Formulation
Pat. Sub. Date(s): 001: Apr 5, 2016 Mar 13, 2029

Pat. No. 9200088 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Apr 5, 2016 Mar 13, 2029

Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): 001: Mar 14, 2017 Feb 27, 2033

Pat. No. 10040872 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Sep 6, 2018 Jan 30, 2034

Pat. No. 10864183 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 15, 2020 May 28, 2030

Pat. No. 10940128 DP* Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Mar 19, 2021 Jun 14, 2030 U-3086: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma

Pat. No. 11020363 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2021 May 28, 2030

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Mar 10, 2023 ODE-110: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma

Patents	Expiration	Patented Use
Pat. No. 8410077 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Compound; Product-by-process; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016	Mar 13, 2029
Pat. No. 9200088 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016	Mar 13, 2029
Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Formulation; Product-by-process; Process Pat. Sub. Date(s): 001: Mar 14, 2017	Feb 27, 2033
Pat. No. 10040872 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 6, 2018	Jan 30, 2034
Pat. No. 10864183 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 15, 2020	May 28, 2030
Pat. No. 10940128 DP* Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Mar 19, 2021	Jun 14, 2030	U-3086: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma
Pat. No. 11020363 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 10, 2021	May 28, 2030
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Mar 10, 2023	ODE-110: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma

ACROTECH
FOLOTYN (SOLUTION) (INTRAVENOUS) PRALATREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ACROTECH NDA No.: 022468 Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (40MG/2ML (20MG/ML))

Patents Expiration Patented Use

Pat. No. 6028071 DS* DP* [Extended 5 years]
Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): All strengths: None Jul 16, 2022 U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None May 31, 2025 U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None May 31, 2025 U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

Patents	Expiration	Patented Use
Pat. No. *6028071* DS* DP* [Extended 5 years] Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): All strengths: None	Jul 16, 2022	U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma
Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): All strengths: None	May 31, 2025	U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma
Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None	May 31, 2025	U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

ACROTECH
FUSILEV (POWDER; SOLUTION) (INTRAVENOUS) LEVOLEUCOVORIN CALCIUM [GENERIC AP]
Drug Classes: Antineoplastics:Treatment Adjuncts == Antineoplastics:Antineoplastics, Other == folate analog
NDA Applicant: ACROTECH NDA No.: 020140 Prod. No.: 001 RX (EQ 50MG BASE/VIAL) NDA No.: 020140 Prod. No.: 002 DISC (EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)); 003 DISC (EQ 250MG BASE/25ML (EQ 10MG BASE/ML))

Patents Expiration Patented Use

Pat. No. 6500829 DS* DP* [Extended 797 days (2.2 years)]
Substantially pure diastereoisomers of tetrahydrofolate derivatives
Claim Types: Formulation
Pat. Sub. Date(s): 001: None; 002: May 9, 2011; 003: May 9, 2011 Mar 7, 2022

Patents	Expiration	Patented Use
Pat. No. *6500829* DS* DP* [Extended 797 days (2.2 years)] Substantially pure diastereoisomers of tetrahydrofolate derivatives Claim Types: Formulation Pat. Sub. Date(s): 001: None; 002: May 9, 2011; 003: May 9, 2011	Mar 7, 2022

ACTELION
OPSUMIT (TABLET) (ORAL) MACITENTAN
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 204410 Prod. No.: 001 RX (10MG)

Patents Expiration Patented Use

Pat. No. 7094781 DS* DP* [Extended 1150 days (3.2 years)]
Sulfamides and their use as endothelin receptor antagonists
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 6, 2013 Dec 5, 2025

Pat. No. 8268847 Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 6, 2013 Apr 18, 2029 U-1446: Method of treating pulmonary hypertension comprising administering macitentan in combination with a compound having phosphodiesterase-5 inhibitory properties

Pat. No. 8367685 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 6, 2013 Oct 4, 2028 U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherin [sic, wherein] the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition

Pat. No. 9265762 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 16, 2016 May 29, 2027 U-1820: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 3% of the weight of said pharmaceutical composition

Pat. No. 10946015 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 8, 2021 Sep 11, 2026 U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherin [sic, wherein] the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition

Patents	Expiration	Patented Use
Pat. No. *7094781* DS* DP* [Extended 1150 days (3.2 years)] Sulfamides and their use as endothelin receptor antagonists Claim Types: Compound Pat. Sub. Date(s): 001: Nov 6, 2013	Dec 5, 2025
Pat. No. 8268847 Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 6, 2013	Apr 18, 2029	U-1446: Method of treating pulmonary hypertension comprising administering macitentan in combination with a compound having phosphodiesterase-5 inhibitory properties
Pat. No. 8367685 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 6, 2013	Oct 4, 2028	U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherin [sic, wherein] the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition
Pat. No. 9265762 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 16, 2016	May 29, 2027	U-1820: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 3% of the weight of said pharmaceutical composition
Pat. No. 10946015 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 8, 2021	Sep 11, 2026	U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherin [sic, wherein] the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition

ACTELION
TRACLEER (TABLET) (ORAL) BOSENTAN [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 021290 Prod. No.: 001 RX (62.5MG); 002 RX (125MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) Sep 5, 2024

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Sep 5, 2024

ACTELION
TRACLEER (TABLET, FOR SUSPENSION) (ORAL) BOSENTAN
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 209279 Prod. No.: 001 RX (32MG)

Patents Expiration Patented Use

Pat. No. 7959945 DP* Dispersible bosentan tablet
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 3, 2017 Dec 28, 2027

Pat. No. 8309126 DP* Dispersible bosentan tablet
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Oct 3, 2017 May 15, 2026

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Sep 5, 2024 ODE-161: Treatment of pulmonary arterial hypertension (PAH) (WHO group 1) in pediatric patients aged 3 yrs and older with idiopathic or congenital pah to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability

Patents	Expiration	Patented Use
Pat. No. 7959945 DP* Dispersible bosentan tablet Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 3, 2017	Dec 28, 2027
Pat. No. 8309126 DP* Dispersible bosentan tablet Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Oct 3, 2017	May 15, 2026
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Sep 5, 2024	ODE-161: Treatment of pulmonary arterial hypertension (PAH) (WHO group 1) in pediatric patients aged 3 yrs and older with idiopathic or congenital pah to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability

ACTELION
UPTRAVI (TABLET) (ORAL) SELEXIPAG
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacyclin receptor agonist
NDA Applicant: ACTELION NDA No.: 207947 Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (0.8MG); 005 RX (1MG); 006 RX (1.2MG); 007 RX (1.4MG); 008 RX (1.6MG)

Patents Expiration Patented Use

Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): All strengths: Jan 19, 2016 Oct 31, 2026 U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag

Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Jan 19, 2016 Aug 1, 2030

Pat. No. 9173881 Therapeutic compositions containing macitentan
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 19, 2016 Aug 12, 2029 U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan

Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 12, 2016 Jun 25, 2030 U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag

Pat. No. 10821108 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 2, 2020 Dec 1, 2036 U-2992: Method of treating pulmonary arterial hypertension comprising administering a solid preparation containing selexipag

Pat. No. 10828298 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsu- lfonyl)acetamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 2, 2020 Dec 1, 2036 U-2991: Method of treating pulmonary arterial hypertension comprising administering a tablet containing selexipag

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Dec 21, 2022 ODE-106: For use of UPTRAVI (selexipag) tablets, 200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg for treatment of pulmonary arterial hypertension (PAH, WHO group I) to reduce the risks of disease progression and hospitalization for pah

Patents	Expiration	Patented Use
Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016	Oct 31, 2026	U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag
Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Jan 19, 2016	Aug 1, 2030
Pat. No. 9173881 Therapeutic compositions containing macitentan Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016	Aug 12, 2029	U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan
Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 12, 2016	Jun 25, 2030	U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag
Pat. No. 10821108 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2020	Dec 1, 2036	U-2992: Method of treating pulmonary arterial hypertension comprising administering a solid preparation containing selexipag
Pat. No. 10828298 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsu- lfonyl)acetamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2020	Dec 1, 2036	U-2991: Method of treating pulmonary arterial hypertension comprising administering a tablet containing selexipag
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Dec 21, 2022	ODE-106: For use of UPTRAVI (selexipag) tablets, 200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg for treatment of pulmonary arterial hypertension (PAH, WHO group I) to reduce the risks of disease progression and hospitalization for pah

ACTELION
UPTRAVI (POWDER) (INTRAVENOUS) SELEXIPAG
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacyclin receptor agonist
NDA Applicant: ACTELION NDA No.: 214275 Prod. No.: 001 RX (1.8MG/VIAL)

Patents Expiration Patented Use

Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: Aug 27, 2021 Oct 31, 2026 U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag

Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Aug 27, 2021 Aug 1, 2030

Pat. No. 9173881 Therapeutic compositions containing macitentan
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 27, 2021 Aug 12, 2029 U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan

Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 27, 2021 Jun 25, 2030 U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag

Patents	Expiration	Patented Use
Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): 001: Aug 27, 2021	Oct 31, 2026	U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag
Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Aug 27, 2021	Aug 1, 2030
Pat. No. 9173881 Therapeutic compositions containing macitentan Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2021	Aug 12, 2029	U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan
Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2021	Jun 25, 2030	U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag

ACTELION
VELETRI (INJECTABLE) (INJECTION) EPOPROSTENOL SODIUM [GENERIC AP2]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacycline vasodilator
NDA Applicant: ACTELION NDA No.: 022260 Prod. No.: 001 RX (EQ 1.5MG BASE/VIAL); 002 RX (EQ 0.5MG BASE/VIAL)

Patents Expiration Patented Use

Pat. No. 8318802 DP* Epoprostenol formulation and method of making thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 26, 2012; 002: None Mar 15, 2027

Pat. No. 8598227 Epoprostenol formulation and method of making thereof
Claim Types: Method of use; Process
Pat. Sub. Date(s): All strengths: None Feb 2, 2027

Patents	Expiration	Patented Use
Pat. No. 8318802 DP* Epoprostenol formulation and method of making thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 26, 2012; 002: None	Mar 15, 2027
Pat. No. 8598227 Epoprostenol formulation and method of making thereof Claim Types: Method of use; Process Pat. Sub. Date(s): All strengths: None	Feb 2, 2027

ADAMAS PHARMA
GOCOVRI (CAPSULE, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other == Antivirals:Anti-influenza Agents == influenza A M2 protein inhibitor
NDA Applicant: ADAMAS PHARMA NDA No.: 208944 Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)

Patents Expiration Patented Use

Pat. No. 8389578 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017 Jan 22, 2028 U-2105: Treatment of dyskinesia in patients with Parkinson's disease receiving immediate release levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 8741343 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017 Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 8796337 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017 Nov 23, 2025 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 8889740 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 21, 2017 Nov 23, 2025

Pat. No. 8895614 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 21, 2017 Nov 23, 2025

Pat. No. 8895615 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017 Nov 23, 2025 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 8895616 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017 Nov 23, 2025 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 8895617 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017 Nov 23, 2025 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 8895618 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 21, 2017 Nov 23, 2025

Pat. No. 9867791 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 16, 2018 Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 9867792 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 16, 2018 Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 9867793 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 16, 2018 Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 9877933 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 30, 2018 Dec 2, 2030 U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 10154971 Methods of administering amantadine
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Dec 18, 2018 Dec 4, 2034 U-2459: Treatment of dyskinesia and decreasing off time in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 10646456 Methods of administering amantadine
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jul 14, 2020 Jun 17, 2034 U-2808: Treatment of dyskinesia, decreasing off time, and increasing on time without troublesome dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 11065213 DP* Amantadine compositions and preparations thereof
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Jul 20, 2021 Aug 23, 2038

Pat. No. 11077073 Methods of using amantadine compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 4, 2021 Aug 23, 2038 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
U-3180: Decreasing off time in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Pat. No. 11197835 Method of administering amantadine prior to a sleep period
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 12, 2022 Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Aug 24, 2024 ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications

Patents	Expiration	Patented Use
Pat. No. 8389578 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017	Jan 22, 2028	U-2105: Treatment of dyskinesia in patients with Parkinson's disease receiving immediate release levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8741343 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017	Dec 2, 2030	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8796337 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017	Nov 23, 2025	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8889740 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017	Nov 23, 2025
Pat. No. 8895614 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017	Nov 23, 2025
Pat. No. 8895615 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017	Nov 23, 2025	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8895616 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017	Nov 23, 2025	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8895617 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017	Nov 23, 2025	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8895618 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017	Nov 23, 2025
Pat. No. 9867791 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018	Dec 2, 2030	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9867792 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018	Dec 2, 2030	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9867793 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018	Dec 2, 2030	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9877933 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 30, 2018	Dec 2, 2030	U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 10154971 Methods of administering amantadine Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Dec 18, 2018	Dec 4, 2034	U-2459: Treatment of dyskinesia and decreasing off time in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 10646456 Methods of administering amantadine Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Jul 14, 2020	Jun 17, 2034	U-2808: Treatment of dyskinesia, decreasing off time, and increasing on time without troublesome dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 11065213 DP* Amantadine compositions and preparations thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: Jul 20, 2021	Aug 23, 2038
Pat. No. 11077073 Methods of using amantadine compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2021	Aug 23, 2038	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications U-3180: Decreasing off time in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 11197835 Method of administering amantadine prior to a sleep period Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 12, 2022	Dec 2, 2030	U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Aug 24, 2024	ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications

ADAMAS PHARMA
OSMOLEX ER (TABLET, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other == Antivirals:Anti-influenza Agents == influenza A M2 protein inhibitor
NDA Applicant: ADAMAS PHARMA NDA No.: 209410 Prod. No.: 001 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE) NDA No.: 209410 Prod. No.: 003 DISC (EQ 258MG BASE); 004 DISC (EQ 161MG BASE)

Patents Expiration Patented Use

Pat. No. 8252331 DP* Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020 Mar 13, 2030

Pat. No. 8389578 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Jan 22, 2028 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease

Pat. No. 8574626 DP* Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020 Nov 28, 2025 U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment

Pat. No. 8796337 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease

Pat. No. 8889740 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Nov 23, 2025

Pat. No. 8895614 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Nov 23, 2025

Pat. No. 8895615 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease

Pat. No. 8895616 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease

Pat. No. 8895617 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease

Pat. No. 8895618 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Nov 23, 2025

Pat. No. 8987333 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Nov 23, 2025

Pat. No. 9072697 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 10, 2021 Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease

Pat. No. 10213393 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020 Feb 15, 2038 U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment

Pat. No. 10213394 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020 Feb 15, 2038 U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients

Pat. No. 10500170 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020 Feb 15, 2038 U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment

Pat. No. 10500171 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020 Feb 15, 2038 U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients

Pat. No. 10500172 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020 Feb 15, 2038 U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients

Pat. No. 10512617 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 2, 2020; 002: Jan 2, 2020; 003: Jan 2, 2020; 004: Oct 29, 2020 Feb 15, 2038 U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients

Patents	Expiration	Patented Use
Pat. No. 8252331 DP* Osmotic device containing amantadine and an osmotic salt Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020	Mar 13, 2030
Pat. No. 8389578 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021	Jan 22, 2028	U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8574626 DP* Osmotic device containing amantadine and an osmotic salt Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020	Nov 28, 2025	U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 8796337 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021	Nov 23, 2025	U-219: Treatment of Parkinson's disease U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8889740 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021	Nov 23, 2025
Pat. No. 8895614 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021	Nov 23, 2025
Pat. No. 8895615 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021	Nov 23, 2025	U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8895616 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021	Nov 23, 2025	U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8895617 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2021	Nov 23, 2025	U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8895618 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021	Nov 23, 2025
Pat. No. 8987333 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021	Nov 23, 2025
Pat. No. 9072697 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2021	Nov 23, 2025	U-219: Treatment of Parkinson's disease U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 10213393 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020	Feb 15, 2038	U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10213394 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020	Feb 15, 2038	U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10500170 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020	Feb 15, 2038	U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10500171 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020	Feb 15, 2038	U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10500172 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020	Feb 15, 2038	U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10512617 Composition and method for treating neurological disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 2, 2020; 002: Jan 2, 2020; 003: Jan 2, 2020; 004: Oct 29, 2020	Feb 15, 2038	U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients

ADDMEDICA SAS
SIKLOS (TABLET) (ORAL) HYDROXYUREA
Drug Classes: Antineoplastics:Antimetabolites
NDA Applicant: ADDMEDICA SAS NDA No.: 208843 Prod. No.: 001 RX (100MG); 002 RX (1GM)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Dec 21, 2024 ODE-177: To reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crisis

ADHERA
PRESTALIA (TABLET) (ORAL) AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == dihydropyridine calcium channel blocker == Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors == angiotensin converting enzyme inhibitor
NDA Applicant: ADHERA NDA No.: 205003 Prod. No.: 001 RX (EQ 2.5MG BASE;3.5MG ); 002 RX (EQ 5MG BASE;7MG); 003 RX (EQ 10MG BASE;14MG)

Patents Expiration Patented Use

Pat. No. 6696481 DS* DP* Salt of perindopril and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 29, 2015 Apr 15, 2023 U-3: Treatment of hypertension

Pat. No. 7846961 DS* DP* .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 29, 2015 Oct 5, 2029 U-3: Treatment of hypertension

ADIENNE SA
TEPADINA (POWDER) (INTRACAVITARY, INTRAVENOUS, INTRAVESICAL) THIOTEPA [GENERIC AP]
Drug Classes: alkylating drug
NDA Applicant: ADIENNE SA NDA No.: 208264 Prod. No.: 001 RX (15MG/VIAL); 002 RX (100MG/VIAL)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: ODE - Orphan drug exclusivity Jan 26, 2024 ODE-129: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan & cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor cell transplantation for peds. patients with class 3 beta-thalassemia

AERIE PHARMS INC
RHOPRESSA (SOLUTION/DROPS) (OPHTHALMIC) NETARSUDIL MESYLATE
Drug Classes: Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == Rho kinase inhibitor
NDA Applicant: AERIE PHARMS INC NDA No.: 208254 Prod. No.: 001 RX (EQ 0.02% BASE)

Patents Expiration Patented Use

Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 21, 2017 Nov 10, 2030 U-1524: Reduction of elevated intraocular pressure

Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 21, 2017 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 21, 2017 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 9415043 DS* Combination therapy
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 21, 2017 Mar 14, 2034

Pat. No. 9931336 DS* DP* Combination therapy
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 11, 2018 Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019 Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 30, 2020 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10588901 DS* DP* Combination therapy
Claim Types: Formulation; Compound; Method of use
Pat. Sub. Date(s): 001: Apr 15, 2020 Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: Jun 10, 2020 Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2021 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2021 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2021 Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure

Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Dec 16, 2021 Mar 14, 2034

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Dec 18, 2022

AERIE PHARMS INC
ROCKLATAN (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST; NETARSUDIL DIMESYLATE
Drug Classes: Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog == Ophthalmic Agents:Ophthalmic Combinations == Rho kinase inhibitor
NDA Applicant: AERIE PHARMS INC NDA No.: 208259 Prod. No.: 001 RX (0.005%;EQ 0.02% BASE)

Patents Expiration Patented Use

Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019 Nov 10, 2030 U-1524: Reduction of elevated intraocular pressure

Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 9415043 DS* Combination therapy
Claim Types: Compound
Pat. Sub. Date(s): 001: Mar 28, 2019 Mar 14, 2034

Pat. No. 9931336 DS* DP* Combination therapy
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019 Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure

Pat. No. 9993470 DS* DP* Combination therapy
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019 Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019 Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 30, 2020 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10588901 DS* DP* Combination therapy
Claim Types: Formulation; Compound; Method of use
Pat. Sub. Date(s): 001: Apr 15, 2020 Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: Jun 10, 2020 Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure

Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2021 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2021 Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure

Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2021 Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure

Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Dec 16, 2021 Mar 14, 2034

Pat. No. 11197853 DP* Combination therapy
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 16, 2021 Mar 14, 2034

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NC - New combination Mar 12, 2022

Exclusivity Code: NCE - New chemical entity Dec 18, 2022

AGILE
TWIRLA (SYSTEM) (TRANSDERMAL) ETHINYL ESTRADIOL; LEVONORGESTREL
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Contraceptives:Contraceptives, Other == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins == progestin-containing intrauterine device (IUD)
NDA Applicant: AGILE NDA No.: 204017 Prod. No.: 001 RX (0.03MG/24HR;0.12MG/24HR)

Patents Expiration Patented Use

Pat. No. 8246978 DP* Dermal delivery device with reduced loss of its volatile components
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Mar 10, 2020 Aug 26, 2028

Pat. No. 8747888 DP* Dermal delivery device with in situ seal
Claim Types: Device; Formulation
Pat. Sub. Date(s): 001: Mar 10, 2020 Jul 10, 2028

Pat. No. 9050348 DP* Dermal delivery device
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 10, 2020 Jul 10, 2028

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NP - New product Feb 14, 2023

AGIOS PHARMS INC
PYRUKYND (TABLET) (ORAL) MITAPIVAT SULFATE
NDA Applicant: AGIOS PHARMS INC NDA No.: 216196 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 20MG BASE); 003 RX (EQ 50MG BASE)

Patents Expiration Patented Use

Pat. No. 8785450 DS* DP* Therapeutic compounds and compositions
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Mar 8, 2022 Feb 24, 2031

Pat. No. 9193701 Pyruvate kinase activators for use in therapy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022 Oct 26, 2032 U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency

Pat. No. 9682080 Pyruvate kinase activators for use in therapy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022 May 3, 2032 U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency

Pat. No. 9980961 Pyruvate kinase activators for use in therapy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022 May 3, 2032 U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency

Pat. No. 10632114 Pyruvate kinase activators for use in therapy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022 May 3, 2032 U-3320: Method for increasing the lifetime of red blood cells (RBCS) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency

Pat. No. 11234976 Methods of using pyruvate kinase activators
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022 Oct 11, 2038 U-3321: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency by administering a daily dose of 10mg to 100mg

Pat. No. 11254652 DS* DP* Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfon- amide
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Mar 8, 2022 Nov 21, 2038

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Feb 17, 2027

AKARX INC
DOPTELET (TABLET) (ORAL) AVATROMBOPAG MALEATE
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents
NDA Applicant: AKARX INC NDA No.: 210238 Prod. No.: 001 RX (EQ 20MG BASE)

Patents Expiration Patented Use

Pat. No. 7638536 DS* DP* 2-Acylaminothiazole derivative or salt thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jun 15, 2018 May 5, 2025

Pat. No. 8338429 2-acylaminothiazole derivative or salt thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2019 Jun 30, 2023 U-2577: Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment

Pat. No. 8765764 2-acylaminothiazole derivative or salt thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 15, 2018 Jan 15, 2023 U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET
U-2578: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure

Exclusivity Expiration Exclusivity Description

Exclusivity Code: I - New Indication Jun 26, 2022 I-802: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

Exclusivity Code: NCE - New chemical entity May 21, 2023

Exclusivity Code: ODE - Orphan drug exclusivity Jun 26, 2026 ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

AKCEA THERAPS
TEGSEDI (SOLUTION) (SUBCUTANEOUS) INOTERSEN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == transthyretin-directed antisense oligonucleotide
NDA Applicant: AKCEA THERAPS NDA No.: 211172 Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))

Patents Expiration Patented Use

Pat. No. 7015315 DS* Gapped oligonucleotides
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018 Mar 21, 2023

Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018 Sep 5, 2023

Pat. No. 8101743 DS* DP* Modulation of transthyretin expression
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018 Apr 1, 2025

Pat. No. 8697860 DP* Diagnosis and treatment of disease
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 1, 2018 Apr 29, 2031

Pat. No. 9061044 DS* Modulation of transthyretin expression
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018 Apr 29, 2031

Pat. No. 9399774 Modulation of transthyretin expression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 1, 2018 Apr 29, 2031 U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Oct 5, 2023

Exclusivity Code: ODE - Orphan drug exclusivity Oct 5, 2025 ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

ALBIREO
BYLVAY (CAPSULE, PELLETS) (ORAL) ODEVIXIBAT
Drug Classes: ileal bile acid transporter (IBAT) inhibitor
NDA Applicant: ALBIREO NDA No.: 215498 Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (1.2MG)

Patents Expiration Patented Use

Pat. No. 7132416 DS* DP* Benzothiazepine and benzothiazepine derivatives with ileal bile acid transport (IBAT) inhibotory activity for the treatment hyperlipidaemia
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): All strengths: Aug 18, 2021 Sep 5, 2022

Pat. No. 9694018 IBAT inhibitors for the treatment of liver disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021 Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)

Pat. No. 10011633 IBAT inhibitors for the treatment of liver diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021 Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)

Pat. No. 10093697 IBAT inhibitors for the treatment of liver diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021 Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)

Pat. No. 10487111 IBAT inhibitors for the treatment of liver diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021 Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)

Pat. No. 10975046 DS* Crystal modifications of odevixibat
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Aug 18, 2021 Jun 20, 2039

Pat. No. 10981952 IBAT inhibitors for the treatment of liver diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021 Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Jul 20, 2026

Exclusivity Code: ODE - Orphan drug exclusivity Jul 20, 2028 ODE-363: Treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC)

ALCON LABS INC
PATADAY ONCE DAILY RELIEF (SOLUTION/DROPS) (OPHTHALMIC) OLOPATADINE HYDROCHLORIDE
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == H1 receptor antagonist == histamine-1 (H1) inhibitor == mast cell stabilizer
NDA Applicant: ALCON LABS INC NDA No.: 206276 Prod. No.: 001 OTC (EQ 0.7% BASE)

Patents Expiration Patented Use

Pat. No. 8791154 DP* High concentration olopatadine ophthalmic composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 31, 2015 May 19, 2032 U-1680: Treatment of ocular itching associated with allergic conjunctivitis

Pat. No. 9533053 DP* High concentration olopatadine ophthalmic composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 31, 2020 May 19, 2032

ALCON LABS INC
SIMBRINZA (SUSPENSION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; BRINZOLAMIDE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == carbonic anhydrase inhibitor
NDA Applicant: ALCON LABS INC NDA No.: 204251 Prod. No.: 001 RX (0.2%;1%)

Patents Expiration Patented Use

Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 9, 2015 Oct 30, 2030

Pat. No. 9421265 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2016 Jun 17, 2030

ALEOR DERMACEUTICALS
MUPIROCIN (CREAM) (TOPICAL) MUPIROCIN CALCIUM [GENERIC AB]
Drug Classes: Dermatological Agents:Topical Anti-infectives == RNA synthetase inhibitor antibacterial
NDA Applicant: ALEOR DERMACEUTICALS NDA No.: 213053 Prod. No.: 001 RX (EQ 2% BASE)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: CGT - Competitive generic therapy Jun 27, 2022

ALEXZA PHARMS
ADASUVE (POWDER) (INHALATION) LOXAPINE
Drug Classes: Antipsychotics:1st Generation/Typical
NDA Applicant: ALEXZA PHARMS NDA No.: 022549 Prod. No.: 001 RX (10MG)

Patents Expiration Patented Use

Pat. No. 6716416 DP* Delivery of antipsychotics through an inhalation route
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2013 May 20, 2022

Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Mar 29, 2013 Aug 18, 2024

Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013 Oct 28, 2024

Pat. No. 8074644 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013 Jul 25, 2022

Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2013 Oct 23, 2026

Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: Apr 29, 2015 May 21, 2024

Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 7, 2016 May 20, 2024

ALIMERA SCIENCES INC
ILUVIEN (IMPLANT) (INTRAVITREAL) FLUOCINOLONE ACETONIDE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Dermatological Agents:Dermatological Agents, Other == Otic Agents:Otic Glucocorticoids == corticosteroid
NDA Applicant: ALIMERA SCIENCES INC NDA No.: 201923 Prod. No.: 001 RX (0.19MG)

Patents Expiration Patented Use

Pat. No. 8871241 DP* Injectable sustained release delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 12, 2014 Aug 12, 2027

ALK ABELLO
OTIPRIO (INJECTABLE, SUSPENSION) (OTIC) CIPROFLOXACIN
Drug Classes: Antibacterials:Quinolones == Ophthalmic Agents:Ophthalmic Anti-Infectives == Otic Agents:Otic Anti-Infectives == Otic Agents:Otic Combinations == quinolone antimicrobial
NDA Applicant: ALK ABELLO NDA No.: 207986 Prod. No.: 001 RX (6% (60MG/ML))

Patents Expiration Patented Use

Pat. No. 8318817 Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 11, 2016 Apr 27, 2030 U-1792: Treatment of otic infection or inflammation

Pat. No. 9205048 Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 11, 2016 Apr 21, 2029 U-1793: Treatment of pediatric patients with otitis media with effusion undergoing tympanostomy tube placement

Pat. No. 9220796 DP* Sterilization of ciprofloxacin composition
Claim Types: Product-by-process; Drug in a container; Process
Pat. Sub. Date(s): 001: Jan 11, 2016 Jul 1, 2035

Pat. No. 9233068 DP* Controlled release antimicrobial compositions and methods for the treatment of OTIC disorders
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 5, 2016 Dec 11, 2029

Pat. No. 9603796 DS* DP* Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 26, 2018 Apr 21, 2029 U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus

Pat. No. 11040004 Otic gel formulations for treating otitis externa
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 21, 2021 Nov 12, 2037 U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus

Pat. No. 11246863 DP* Ciprofloxacin otic composition and kits and method for using same
Claim Types: Kit
Pat. Sub. Date(s): 001: Mar 11, 2022 Nov 27, 2038

ALKEM LABS LTD
MORPHINE SULFATE (TABLET) (ORAL) MORPHINE SULFATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ALKEM LABS LTD NDA No.: 212451 Prod. No.: 001 RX (15MG); 002 RX (30MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: CGT - Competitive generic therapy Aug 10, 2021

ALKERMES
VIVITROL (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) NALTREXONE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist
NDA Applicant: ALKERMES NDA No.: 021897 Prod. No.: 001 RX (380MG/VIAL)

Patents Expiration Patented Use

Pat. No. 7919499 Naltrexone long acting formulations and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 16, 2011 Oct 15, 2029 U-1123: Treatment of alcohol dependence
U-1124: Prevention of relapse to opioid dependence, following opioid detoxification

ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))

Patents Expiration Patented Use

Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 Oct 26, 2030

Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 Jun 24, 2030 U-543: Treatment of schizophrenia

Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 Nov 7, 2032 U-543: Treatment of schizophrenia

Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017 Oct 24, 2033 U-543: Treatment of schizophrenia

Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017 Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Nov 20, 2018 Jun 24, 2030 U-543: Treatment of schizophrenia

Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 8, 2019 Mar 19, 2032 U-543: Treatment of schizophrenia

Pat. No. 10238651 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Apr 8, 2019 Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

Pat. No. 10813928 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 10, 2020 Mar 19, 2035 U-2983: Treatment of schizophrenia by rapid and continuous injection

Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 21, 2021 Oct 24, 2033 U-764: Treatment of schizophrenia

Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 13, 2022 Apr 6, 2039 U-543: Treatment of schizophrenia

ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML))

Patents Expiration Patented Use

Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 002: Oct 14, 2015 Oct 26, 2030

Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015 Jun 24, 2030 U-543: Treatment of schizophrenia

Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015 Nov 7, 2032 U-543: Treatment of schizophrenia

Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Dec 9, 2015 Oct 24, 2033 U-543: Treatment of schizophrenia

Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Oct 5, 2016 Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 002: Jan 19, 2017 Mar 19, 2035

Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Nov 20, 2018 Jun 24, 2030 U-543: Treatment of schizophrenia

Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 8, 2019 Mar 19, 2032 U-543: Treatment of schizophrenia

Pat. No. 10238651 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 002: Apr 8, 2019 Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

Pat. No. 10813928 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 10, 2020 Mar 19, 2035 U-2983: Treatment of schizophrenia by rapid and continuous injection

Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 21, 2021 Oct 24, 2033 U-764: Treatment of schizophrenia

Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 13, 2022 Apr 6, 2039 U-543: Treatment of schizophrenia

ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 003 RX (882MG/3.2ML (275.63MG/ML))

Patents Expiration Patented Use

Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 003: Oct 14, 2015 Oct 26, 2030

Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015 Jun 24, 2030 U-543: Treatment of schizophrenia

Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015 Nov 7, 2032 U-543: Treatment of schizophrenia

Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Dec 9, 2015 Oct 24, 2033 U-543: Treatment of schizophrenia

Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Oct 5, 2016 Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 003: Jan 19, 2017 Mar 19, 2035

Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Nov 20, 2018 Jun 24, 2030 U-543: Treatment of schizophrenia

Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 8, 2019 Mar 19, 2032 U-543: Treatment of schizophrenia

Pat. No. 10238651 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: Apr 8, 2019 Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

Pat. No. 10813928 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 003: Nov 10, 2020 Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 21, 2021 Oct 24, 2033 U-764: Treatment of schizophrenia

Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 13, 2022 Apr 6, 2039 U-543: Treatment of schizophrenia

ALKERMES INC
ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 209830 Prod. No.: 001 RX (675MG/2.4ML)

Patents Expiration Patented Use

Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 18, 2018 Oct 26, 2030

Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 18, 2018 Jun 24, 2030 U-543: Treatment of schizophrenia

Pat. No. 10016415 DP* Aripiprazole prodrug compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 18, 2018 Sep 8, 2035

Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018 Jun 24, 2030 U-543: Treatment of schizophrenia

Pat. No. 10688091 DP* Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 8, 2020 Aug 17, 2035

Pat. No. 10849894 Aripiprazole prodrug composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2020 Aug 17, 2035 U-543: Treatment of schizophrenia

Pat. No. 11154552 DP* Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 10, 2021 Aug 17, 2035

Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 13, 2022 Apr 6, 2039 U-543: Treatment of schizophrenia

ALKERMES INC
LYBALVI (TABLET) (ORAL) OLANZAPINE; SAMIDORPHAN L-MALATE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic == opioid antagonist
NDA Applicant: ALKERMES INC NDA No.: 213378 Prod. No.: 001 RX (5MG;EQ 10MG BASE); 002 RX (10MG;EQ 10MG BASE); 003 RX (15MG;EQ 10MG BASE); 004 RX (20MG;EQ 10MG BASE)

Patents Expiration Patented Use

Pat. No. 7262298 DS* 4-hydroxybenzomorphans
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Jun 25, 2021 Nov 23, 2025

Pat. No. 8778960 Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2021 Feb 13, 2032 U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain

Pat. No. 9119848 DS* Morphinan derivatives for the treatment of drug overdose
Claim Types: Method of use; Compound
Pat. Sub. Date(s): All strengths: Jun 25, 2021 Aug 30, 2031

Pat. No. 9126977 DP* Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: Jun 25, 2021 Aug 23, 2031 U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain

Pat. No. 9517235 Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2021 Aug 23, 2031 U-3138: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile
U-3139: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile

Pat. No. 10300054 DP* Methods for treating antipsychotic-induced weight gain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2021 Aug 23, 2031 U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan
U-3141: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan

Pat. No. 10716785 Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2021 Aug 23, 2031 U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain

Pat. No. 11185541 Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 22, 2021 Aug 23, 2031 U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan

Pat. No. 11241425 Composition for treating mental illness
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Mar 3, 2022 Aug 23, 2031 U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity May 28, 2026

ALLERGAN
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN NDA No.: 021528 Prod. No.: 001 RX (0.4%)

Patents Expiration Patented Use

Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 23, 2011 Nov 24, 2027 *PED U-1181: A method of treating or preventing ocular pain in a patient

Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2012 Nov 28, 2024 *PED U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient

Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 18, 2013 Nov 28, 2024 *PED U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery

Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2013 Nov 28, 2024 *PED U-1441: A method of treating or reducing ocular pain and burning/stinging

Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 4, 2014 May 28, 2024

Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 8, 2015 May 28, 2024 U-1626: A method of treating or preventing ocular pain and burning

Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Mar 4, 2015 May 28, 2024 U-1662: A method of treating ocular pain

Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016 May 28, 2024 U-1800: A method of treating ocular pain and/or enhancing ocular comfort

ALLERGAN
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN NDA No.: 022427 Prod. No.: 001 RX (0.45%)

Patents Expiration Patented Use

Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 30, 2010 Aug 15, 2029

Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 19, 2013 Mar 7, 2028

Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 10, 2015 Aug 5, 2024

Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2015 Mar 7, 2028

ALLERGAN
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AT]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021262 Prod. No.: 001 RX (0.15%)

Patents Expiration Patented Use

Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Jan 10, 2022 *PED

Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Jan 18, 2022 *PED

Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Jan 28, 2022 *PED

Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Jan 26, 2022 *PED

Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2016 Jan 10, 2022 *PED U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension

ALLERGAN
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021770 Prod. No.: 001 RX (0.1%)

Patents Expiration Patented Use

Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Jan 10, 2022 *PED

Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Jan 18, 2022 *PED

Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Jan 28, 2022 *PED

Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Jan 26, 2022 *PED

Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 13, 2014 Mar 2, 2024 *PED

Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2016 Jan 10, 2022 *PED U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension

Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 10, 2017 Jan 10, 2022 *PED

ALLERGAN
AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor == Antibacterials:Beta-lactam, Cephalosporins == cephalosporin antibacterial
NDA Applicant: ALLERGAN NDA No.: 206494 Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)

Patents Expiration Patented Use

Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 17, 2015 Jan 7, 2026 U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pnenumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium
U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium
U-282: Method of treating bacterial infections

Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015 Nov 12, 2026

Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Mar 17, 2015 Aug 12, 2031

Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015 Oct 8, 2030

Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Mar 17, 2015 Jun 15, 2032

Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Feb 24, 2017 Jun 15, 2032

Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Formulation; Compound; Composition
Pat. Sub. Date(s): 001: Aug 8, 2017 Jun 15, 2032

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Feb 25, 2025 GAIN

ALLERGAN
BYVALSON (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Drug Classes: Cardiovascular Agents:Beta-adrenergic Blocking Agents == beta-adrenergic receptor inhibitor == Cardiovascular Agents:Angiotensin II Receptor Antagonists == Cardiovascular Agents:Cardiovascular Combinations == angiotensin II receptor blocker
NDA Applicant: ALLERGAN NDA No.: 206302 Prod. No.: 001 DISC (EQ 5MG BASE;80MG)

Patents Expiration Patented Use

Pat. No. 7803838 DP* Compositions comprising nebivolol
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 5, 2016 Aug 29, 2026

Pat. No. 7838552 Compositions comprising nebivolol
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 5, 2016 Oct 4, 2027 U-185: Method of treating hypertension

ALLERGAN
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE [GENERIC AB]
Drug Classes: Inflammatory Bowel Disease Agents:Aminosalicylates and/ or Prodrugs
NDA Applicant: ALLERGAN NDA No.: 021252 Prod. No.: 002 RX (1GM)

Patents Expiration Patented Use

Pat. No. 8217083 DP* Mesalamine suppository
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 24, 2013 Jun 6, 2028

Pat. No. 8436051 DP* Mesalamine suppository
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 24, 2013 Jun 6, 2028

ALLERGAN
COMBIGAN (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; TIMOLOL MALEATE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == Antimigraine Agents:Antimigraine Agents, Other == Cardiovascular Agents:Beta-adrenergic Blocking Agents == beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN NDA No.: 021398 Prod. No.: 001 RX (0.2%;EQ 0.5% BASE)

Patents Expiration Patented Use

Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Apr 19, 2022 U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily

Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Apr 19, 2022 U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily

Pat. No. 7642258 DS* DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: None Apr 19, 2022 U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP

Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 2, 2012 Apr 19, 2022 U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension

Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Mar 27, 2013 Apr 19, 2022 U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma

Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 7, 2014 Apr 19, 2022 U-1524: Reduction of elevated intraocular pressure

Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2016 Apr 19, 2022 U-1524: Reduction of elevated intraocular pressure

Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 12, 2017 Apr 19, 2022 U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid

Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 7, 2018 Apr 19, 2022 U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid

Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 7, 2018 Apr 19, 2022 U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid

ALLERGAN
DALVANCE (POWDER) (INTRAVENOUS) DALBAVANCIN HYDROCHLORIDE
Drug Classes: Antibacterials:Antibacterials, Other == lipoglycopeptide antibacterial
NDA Applicant: ALLERGAN NDA No.: 021883 Prod. No.: 001 RX (EQ 500MG BASE/VIAL)

Patents Expiration Patented Use

Pat. No. 6900175 Methods of administering dalbavancin for treatment of bacterial infections
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 13, 2014 Dec 25, 2023 U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin.

Pat. No. 7115564 DP* Stable pharmaceutical compositions of dalbavancin and methods of administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 13, 2014 Nov 14, 2023

Pat. No. 7119061 DP* Dalbavancin compositions for treatment of bacterial infections
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 13, 2014 Nov 14, 2023

Pat. No. 8143212 Dalbavancin compositions for treatment of bacterial infections
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 13, 2014 Nov 14, 2023 U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin.

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity May 23, 2024 GAIN

Exclusivity Code: NPP - New patient population Jul 22, 2024

ALLERGAN
FETZIMA (CAPSULE, EXTENDED RELEASE) (ORAL) LEVOMILNACIPRAN HYDROCHLORIDE
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALLERGAN NDA No.: 204168 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 80MG BASE); 004 RX (EQ 120MG BASE)

Patents Expiration Patented Use

Pat. No. RE43879 Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 15, 2013 Jan 11, 2026 U-839: Treatment of major depressive disorder (MDD)

Pat. No. 8481598 Stable dosage forms of levomilnacipran
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Aug 15, 2013 Mar 2, 2031 U-839: Treatment of major depressive disorder (MDD)

Pat. No. 8865937 DS* DP* Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): All strengths: Nov 20, 2014 May 23, 2032

Exclusivity Expiration Exclusivity Description

Exclusivity Code: M - Miscellaneous Oct 7, 2022 M-249: Information added to the labeling to describe study LVM-MD-15 to fulfill postmarketing commitment 1943-4

ALLERGAN
GELNIQUE (GEL) (TRANSDERMAL) OXYBUTYNIN CHLORIDE
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary == muscarinic antagonist
NDA Applicant: ALLERGAN NDA No.: 022204 Prod. No.: 001 RX (10% (100MG/PACKET))

Patents Expiration Patented Use

Pat. No. 8920392 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Claim Types: Drug in a container; Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 27, 2015 Mar 26, 2031 U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin

Pat. No. 9259388 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 16, 2016 Nov 6, 2029 U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin

Pat. No. 10449173 DP* Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Oct 30, 2019 Nov 6, 2029 U-2637: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence with a single unit dose of 10% oxybutynin chloride gel

ALLERGAN
GELNIQUE 3% (GEL, METERED) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary == muscarinic antagonist
NDA Applicant: ALLERGAN NDA No.: 202513 Prod. No.: 001 DISC (3%)

Patents Expiration Patented Use

Pat. No. 7198801 DP* Formulations for transdermal or transmucosal application
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 27, 2012 Jun 25, 2022

ALLERGAN
LASTACAFT (SOLUTION/DROPS) (OPHTHALMIC) ALCAFTADINE
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == histamine-1 (H1) receptor antagonist
NDA Applicant: ALLERGAN NDA No.: 022134 Prod. No.: 001 OTC (0.25%)

Patents Expiration Patented Use

Pat. No. 8664215 Ocular allergy treatments with alcaftadine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2014 Dec 23, 2027 U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander

Pat. No. 10617695 DP* Ophthalmic compositions containing alcaftadine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 12, 2020 Mar 19, 2027 U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander

ALLERGAN
LATISSE (SOLUTION/DROPS) (TOPICAL) BIMATOPROST [GENERIC AT]
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog
NDA Applicant: ALLERGAN NDA No.: 022369 Prod. No.: 001 RX (0.03%)

Patents Expiration Patented Use

Pat. No. 8038988 DS* DP* Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 31, 2011 Aug 25, 2023 U-1208: Treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness

Pat. No. 8101161 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 10, 2012 May 25, 2024 U-1217: Method of increasing hair growth
U-1218: Method of stimulating hair growth

Pat. No. 8263054 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 17, 2012 Jan 15, 2023 U-1277: Method of increasing eyelash growth including length, thickness, darkness and/or number of eyelashes by administering bimatoprost to an eyelid margin

Pat. No. 8632760 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2014 Jan 15, 2023 U-1487: Method of increasing eyelash growth

Pat. No. 8758733 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 16, 2014 Jan 15, 2023 U-1487: Method of increasing eyelash growth

Pat. No. 8986715 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 1, 2015 Jan 15, 2023 U-1217: Method of increasing hair growth

Pat. No. 9216183 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016 Jan 15, 2023 U-1487: Method of increasing eyelash growth

Pat. No. 9226931 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016 Jan 15, 2023 U-1799: Method of increasing growth of hair including eyelashes

ALLERGAN
LEXAPRO (TABLET) (ORAL) ESCITALOPRAM OXALATE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == Anxiolytics:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ALLERGAN NDA No.: 021323 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE)

Patents Expiration Patented Use

Pat. No. 6916941 DS* DP* Crystalline composition containing escitalopram
Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation
Pat. Sub. Date(s): All strengths: None Feb 12, 2023 *PED

Pat. No. 7420069 DP* Crystalline composition containing escitalopram
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: None Feb 12, 2023 *PED

ALLERGAN
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: ALLERGAN NDA No.: 202811 Prod. No.: 001 RX (145MCG)

Patents Expiration Patented Use

Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)]
Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012 Aug 30, 2026 U-1278: Method of treating irritable bowel syndrome with constipation in adults
U-1516: Method of treating chronic idiopathic constipation in adult patients.

Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Sep 18, 2012 Jan 28, 2024

Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012 Jan 28, 2024

Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012 Jan 28, 2024

Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012 Jan 28, 2024

Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 18, 2012 Jan 28, 2024 U-1278: Method of treating irritable bowel syndrome with constipation in adults

Pat. No. 8748573 Formulations comprising linaclotide
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 11, 2014 Oct 30, 2031 U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.

Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 19, 2014 Oct 30, 2031

Pat. No. 8933030 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 6, 2015 Feb 17, 2031

Pat. No. 9708371 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 10, 2017 Aug 16, 2033 U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.

ALLERGAN
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: ALLERGAN NDA No.: 202811 Prod. No.: 002 RX (290MCG)

Patents Expiration Patented Use

Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)]
Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 002: None Aug 30, 2026 U-1278: Method of treating irritable bowel syndrome with constipation in adults
U-1516: Method of treating chronic idiopathic constipation in adult patients.

Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: None Jan 28, 2024

Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None Jan 28, 2024

Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None Jan 28, 2024

Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None Jan 28, 2024

Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: None Jan 28, 2024 U-1278: Method of treating irritable bowel syndrome with constipation in adults

Pat. No. 8748573 Formulations comprising linaclotide
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 11, 2014 Oct 30, 2031 U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.

Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): 002: Aug 19, 2014 Oct 30, 2031

Pat. No. 8933030 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Feb 6, 2015 Feb 17, 2031

Pat. No. 9708371 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Aug 10, 2017 Aug 16, 2033 U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.

ALLERGAN
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: ALLERGAN NDA No.: 202811 Prod. No.: 003 RX (72MCG)

Patents Expiration Patented Use

Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)]
Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017 Aug 30, 2026 U-1516: Method of treating chronic idiopathic constipation in adult patients.

Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 003: Feb 24, 2017 Jan 28, 2024

Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017 Jan 28, 2024

Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017 Jan 28, 2024

Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017 Jan 28, 2024

Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Method of use
Pat. Sub. Date(s): 003: Feb 24, 2017 Jan 28, 2024 U-1516: Method of treating chronic idiopathic constipation in adult patients.

Pat. No. 8933030 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 003: Feb 24, 2017 Feb 17, 2031 U-1516: Method of treating chronic idiopathic constipation in adult patients.

Pat. No. 9708371 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 003: Aug 10, 2017 Aug 16, 2033 U-1516: Method of treating chronic idiopathic constipation in adult patients.

Pat. No. 10675325 DP* Stable formulations of linaclotide
Claim Types: Composition
Pat. Sub. Date(s): 003: Jun 22, 2020 Aug 11, 2031

Pat. No. 10702576 Stable formulations of linaclotide
Claim Types: Method of use
Pat. Sub. Date(s): 003: Aug 4, 2020 Aug 11, 2031 U-1516: Method of treating chronic idiopathic constipation in adult patients.

ALLERGAN
LUMIGAN (SOLUTION/DROPS) (OPHTHALMIC) BIMATOPROST
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog
NDA Applicant: ALLERGAN NDA No.: 022184 Prod. No.: 001 RX (0.01%)

Patents Expiration Patented Use

Pat. No. 7851504 DS* DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Jun 13, 2027

Pat. No. 8278353 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 2, 2012 Mar 16, 2025

Pat. No. 8299118 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2012 Mar 16, 2025 U-1295: A method of treating a patient with glaucoma or ocular hypertension

Pat. No. 8309605 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2012 Mar 16, 2025 U-1293: A method of lowering intraocular pressure in a patient with open angle glaucoma or ocular hypertension
U-1294: Method of treating glaucoma in a patient

Pat. No. 8338479 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: ;Composition; Method of administration
Pat. Sub. Date(s): 001: Dec 26, 2012 Mar 16, 2025 U-1295: A method of treating a patient with glaucoma or ocular hypertension

Pat. No. 8524777 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2013 Mar 16, 2025 U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension

Pat. No. 8586630 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Mar 16, 2025 U-1458: A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension

Pat. No. 8772338 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 21, 2014 Mar 16, 2025 U-1528: A method of lowering intraocular pressure

Pat. No. 8933120 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 10, 2015 Mar 16, 2025

Pat. No. 8933127 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 10, 2015 Mar 16, 2025

Pat. No. 9155716 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 12, 2015 Mar 16, 2025 U-1528: A method of lowering intraocular pressure

Pat. No. 9241918 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 24, 2016 Mar 16, 2025 U-1814: Method of treating glaucoma or elevated intraocular pressure

ALLERGAN
NAMENDA XR (CAPSULE, EXTENDED RELEASE) (ORAL) MEMANTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antidementia Agents:N-methyl-D-aspartate (NMDA) Receptor Antagonist == Antidementia Agents:Antidementia Agents, Other
NDA Applicant: ALLERGAN NDA No.: 022525 Prod. No.: 001 RX (7MG); 002 RX (14MG); 003 RX (21MG); 004 RX (28MG)

Patents Expiration Patented Use

Pat. No. 8039009 Modified release formulations of memantine oral dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2011; 002: None; 003: None; 004: None Sep 24, 2029 *PED U-539: Treatment of moderate to severe dementia of the Alzheimer's type

ALLERGAN
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: Antidementia Agents:Cholinesterase Inhibitors == acetylcholinesterase inhibitor == Antidementia Agents:N-methyl-D-aspartate (NMDA) Receptor Antagonist == Antidementia Agents:Antidementia Agents, Other
NDA Applicant: ALLERGAN NDA No.: 206439 Prod. No.: 001 RX (10MG;14MG); 002 RX (10MG;28MG); 003 RX (10MG;7MG); 004 RX (10MG;21MG)

Patents Expiration Patented Use

Pat. No. 8039009 Modified release formulations of memantine oral dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: None; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 Sep 24, 2029 *PED U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type

Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 Dec 5, 2029 U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type

Pat. No. 8168209 DP* Method and composition for administering an NMDA receptor antagonist to a subject
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 May 22, 2026 *PED

Pat. No. 8173708 Method and composition for administering an NMDA receptor antagonist to a subject
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 May 22, 2026 *PED U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type

Pat. No. 8283379 Methods and compositions for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 May 22, 2026 *PED U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type

Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 Nov 22, 2025

Pat. No. 8329752 DP* Composition for administering an NMDA receptor antagonist to a subject
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 May 22, 2026 *PED

Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 Nov 22, 2025

Pat. No. 8338486 Methods for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 Nov 22, 2025 U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type

Pat. No. 8362085 Method for administering an NMDA receptor antagonist to a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 May 22, 2026 *PED U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type

Pat. No. 8580858 Compositions for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 Nov 22, 2025 U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type

Pat. No. 8598233 DP* Method for administering an NMDA receptor antagonist to a subject
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 May 22, 2026 *PED

ALLERGAN
OZURDEX (IMPLANT) (INTRAVITREAL) DEXAMETHASONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid
NDA Applicant: ALLERGAN NDA No.: 022315 Prod. No.: 001 RX (0.7MG)

Patents Expiration Patented Use

Pat. No. 6899717 Methods and apparatus for delivery of ocular implants
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None Nov 1, 2023 U-1206: Delivering an ocular implant as described in the dosage and administration section of the approved labeling of OZURDEX

Pat. No. 8034366 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 23, 2011 Jan 9, 2023 U-1204: Treatment of uveitis
U-1205: Treatment of macular edema

Pat. No. 8034370 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 23, 2011 Jan 9, 2023

Pat. No. 8506987 Ocular implant made by a double extrusion process
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 11, 2013 Jan 9, 2023 U-1204: Treatment of uveitis
U-1205: Treatment of macular edema

Pat. No. 9192511 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2015 Jan 9, 2023

Pat. No. 10076526 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 17, 2018 Jan 9, 2023

Pat. No. 10702539 Ocular implant made by a double extrusion process
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 7, 2020 Jan 9, 2023 U-1597: Treatment of diabetic macular edema
U-2868: Treatment of non-infectious uveitis affecting the posterior segment of the eye
U-985: Treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

ALLERGAN
RESTASIS MULTIDOSE (EMULSION) (OPHTHALMIC) CYCLOSPORINE [Has competitive generic]
Drug Classes: Immunological Agents:Immunosuppressants == Ophthalmic Agents:Ophthalmic Agents, Other == calcineurin inhibitor immunosuppressant
NDA Applicant: ALLERGAN NDA No.: 050790 Prod. No.: 002 RX (0.05%)

Patents Expiration Patented Use

Pat. No. 8292129 DP* Dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 26, 2017 Feb 25, 2031

Pat. No. 8561859 DP* Dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 26, 2017 Apr 16, 2032

Pat. No. 8629111 DP* Methods of providing therapeutic effects using cyclosporin components
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 18, 2016 Aug 27, 2024

Pat. No. 8633162 Methods of providing therapeutic effects using cyclosporin components
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 18, 2016 Aug 27, 2024 U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye).

Pat. No. 8642556 DP* Methods of providing therapeutic effects using cyclosporin components
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 18, 2016 Aug 27, 2024

Pat. No. 8648048 Methods of providing therapeutic effects using cyclosporin components
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 18, 2016 Aug 27, 2024 U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Pat. No. 8685930 DP* Methods of providing therapeutic effects using cyclosporin components
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 18, 2016 Aug 27, 2024

Pat. No. 9248191 Methods of providing therapeutic effects using cyclosporin components
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 18, 2016 Aug 27, 2024 U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye).

Pat. No. 9669974 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 26, 2017 May 11, 2034

Pat. No. 9676525 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 26, 2017 Feb 7, 2034

ALLERGAN
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE)

Patents Expiration Patented Use

Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 10, 2017 Oct 6, 2026 *PED U-1064: Treatment of bipolar disorder and schizophrenia
U-1960: Use of the atypical antipsychotic asenapine for treatment of schizophrenia in adults
U-1961: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes (ages 10 to adult)
U-1962: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: maintenance monotherapy in adults
U-1963: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or valproate in adults

Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Jul 29, 2014 Oct 6, 2026 *PED

ALLERGAN
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 003 RX (EQ 2.5MG BASE)

Patents Expiration Patented Use

Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 003: Sep 12, 2016 Oct 6, 2026 *PED U-1893: Method of treating manic or mixed episodes associated with bipolar disorder in pediatric patients
U-1966: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes in pediatric patients age 10-17

Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 003: Sep 12, 2016 Oct 6, 2026 *PED

ALLERGAN
SAVELLA (TABLET) (ORAL) MILNACIPRAN HYDROCHLORIDE
Drug Classes: Central Nervous System Agents:Fibromyalgia Agents == serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALLERGAN NDA No.: 022256 Prod. No.: 001 RX (12.5MG); 002 RX (25MG); 003 RX (50MG); 004 RX (100MG)

Patents Expiration Patented Use

Pat. No. 6602911 [Extended 435 days (1.2 years)]
Methods of treating fibromyalgia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None Jan 14, 2023 U-882: Management of fibromyalgia (FM)

Pat. No. 7994220 Milnacipran for the long-term treatment of fibromyalgia syndrome
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None; 004: None Sep 19, 2029 U-819: Management of fibromyalgia

ALLERGAN
TEFLARO (POWDER) (INTRAVENOUS) CEFTAROLINE FOSAMIL
Drug Classes: Antibacterials:Beta-lactam, Cephalosporins == cephalosporin antibacterial
NDA Applicant: ALLERGAN NDA No.: 200327 Prod. No.: 001 RX (400MG/VIAL); 002 RX (600MG/VIAL)

Patents Expiration Patented Use

Pat. No. 6417175 DS* DP* [Extended 1211 days (3.3 years)]
Phosphonocephem derivatives, process for the preparation of the same, and use thereof
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: None Apr 11, 2022 U-1676: Methods for treating bacterial infections

Pat. No. 8247400 DP* Cephem compounds useful for the treatment of bacterial infections
Claim Types: Compound; Composition; Method of use; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None Feb 10, 2031 U-282: Method of treating bacterial infections

Pat. No. 9629861 DP* Compositions and methods for treating bacterial infections using ceftaroline
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 17, 2017 Sep 21, 2030

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NPP - New patient population Sep 13, 2022

ALLERGAN
UBRELVY (TABLET) (ORAL) UBROGEPANT
Drug Classes: Antimigraine Agents:Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist
NDA Applicant: ALLERGAN NDA No.: 211765 Prod. No.: 001 RX (50MG); 002 RX (100MG)

Patents Expiration Patented Use

Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jan 21, 2020 Jul 19, 2032 U-2717: Acute treatment of migraine with headache, with or without aura in adults

Pat. No. 8912210 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Jan 21, 2020 Nov 10, 2031

Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jan 21, 2020 Nov 10, 2031 U-2718: Acute treatment of migraine with or without aura in adults

Pat. No. 9833448 Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 21, 2020 Nov 10, 2031 U-2718: Acute treatment of migraine with or without aura in adults

Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 21, 2020 Jan 30, 2035

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Dec 23, 2024

ALLERGAN
VIIBRYD (TABLET) (ORAL) VILAZODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
NDA Applicant: ALLERGAN NDA No.: 022567 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG)

Patents Expiration Patented Use

Pat. No. 7834020 DS* DP* Polymorphic forms of 1-'4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Claim Types: New polymorph, salt or hydrate; Method of use; Process
Pat. Sub. Date(s): 001: Jan 25, 2011; 002: None; 003: None Dec 5, 2022 *PED U-839: Treatment of major depressive disorder (MDD)

Pat. No. 8193195 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl) butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 14, 2012 Dec 5, 2022 *PED U-839: Treatment of major depressive disorder (MDD)

Pat. No. 8236804 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl)piperazine hydrochloride
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 14, 2012; 002: None; 003: None Dec 5, 2022 *PED U-839: Treatment of major depressive disorder (MDD)

Pat. No. 8673921 DS* DP* Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Mar 21, 2014 Dec 5, 2022 *PED

Exclusivity Expiration Exclusivity Description

Exclusivity Code: M - Miscellaneous Jul 31, 2023 PED M-254: Information added to the labeling regarding pediatric patients ages 7 to 17 years of age with major depressive disorder

ALLERGAN
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: Antipsychotics:2nd Generation/Atypical == atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 204370 Prod. No.: 001 RX (EQ 1.5MG BASE)

Patents Expiration Patented Use

Pat. No. RE47350 Pharmaceutical formulations containing dopamine receptor ligands
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 15, 2019 Jul 16, 2029 U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine

Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Claim Types: Compound; Process; Method of use; Composition
Pat. Sub. Date(s): 001: Oct 16, 2015 Sep 17, 2029 U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine

Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): 001: Oct 16, 2015 Dec 16, 2028

Exclusivity Expiration Exclusivity Description

Exclusivity Code: I - New Indication May 24, 2022 I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression)

ALLERGAN HOLDINGS
VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: Gastrointestinal Agents:Anti-Diarrheal Agents == mu-opioid receptor agonist
NDA Applicant: ALLERGAN HOLDINGS NDA No.: 206940 Prod. No.: 001 RX (75MG); 002 RX (100MG)

Patents Expiration Patented Use

Pat. No. 7741356 DS* DP* Compounds as opioid receptor modulators
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Jun 26, 2015 May 27, 2029

Pat. No. 7786158 DS* Compounds as opioid receptor modulators
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Jun 26, 2015 Mar 14, 2025

Pat. No. 8344011 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 26, 2015 Mar 14, 2025 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).

Pat. No. 8609709 DS* Compounds as opioid receptor modulators
Claim Types: Compound; New polymorph, salt, or hydrate
Pat. Sub. Date(s): All strengths: Jun 26, 2015 Mar 14, 2025

Pat. No. 8691860 DS* Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl
Claim Types: New polymorph, salt, or hydrate; Method of use
Pat. Sub. Date(s): All strengths: Jun 26, 2015 Jul 7, 2028 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).

Pat. No. 8772325 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 16, 2017 Mar 14, 2025 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).

Pat. No. 9115091 DS* DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): All strengths: Sep 23, 2015 Jul 7, 2028 U-1738: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline)

Pat. No. 9205076 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 30, 2015 Mar 14, 2025 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).

Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 14, 2016 Jul 7, 2028 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).

Pat. No. 9675587 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 7, 2017 Mar 14, 2033

Pat. No. 9700542 DP* Compounds as opioid receptor modulators
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Aug 7, 2017 Mar 14, 2025

Pat. No. 9789125 DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use
Pat. Sub. Date(s): All strengths: Nov 1, 2017 Jul 7, 2028 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)

Pat. No. 10188632 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 28, 2019 Mar 14, 2033

Pat. No. 10213415 DS* Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 21, 2019 Mar 14, 2025 U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)

Pat. No. 11007179 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 3, 2021 Mar 14, 2033

Pat. No. 11090291 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 7, 2021 Mar 14, 2033

Pat. No. 11160792 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 24, 2021 Mar 14, 2033

Pat. No. 11229627 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 15, 2022 Mar 14, 2033

ALLERGAN INC
DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog
NDA Applicant: ALLERGAN INC NDA No.: 211911 Prod. No.: 001 RX (10MCG)

Patents Expiration Patented Use

Pat. No. 7799336 DP* Hypotensive lipid-containing biodegradable intraocular implants and related methods
Claim Types: Device; Product-by-process
Pat. Sub. Date(s): 001: Mar 24, 2020 Apr 24, 2029

Pat. No. 8206737 Hypotensive lipid-containing biodegradable intraocular implants and related methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020 Apr 7, 2027 U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant

Pat. No. 8629185 DS* DP* 7-[3,5-dihydroxy-2- (3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-N-ethyl-hept-5-enamide (bimatoprost) in crystalline form II, methods for preparation, and methods for use thereof
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Mar 24, 2020 Jul 15, 2031

Pat. No. 8673341 Intraocular pressure reduction with intracameral bimatoprost implants
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020 Feb 19, 2025 U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant

Pat. No. 9149428 DP* Processes for making cyclic lipid implants for intraocular use
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 24, 2020 Dec 19, 2026

Pat. No. 9492316 DP* Prostamide-containing intraocular implants and methods of use thereof
Claim Types: Device; Method of use; Process
Pat. Sub. Date(s): 001: Mar 24, 2020 Oct 31, 2034

Pat. No. 9980974 Prostamide-containing intraocular implants and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020 Oct 31, 2034 U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant

Pat. No. 10398707 Hypotensive lipid-containing biodegradable intraocular implants and related implants
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020 Apr 30, 2024 U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant

Pat. No. 10441543 DP* Processes for making cyclic lipid implants for intraocular use
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 24, 2020 Dec 19, 2026

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NP - New product Mar 4, 2023

ALMATICA
FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone
NDA Applicant: ALMATICA NDA No.: 022497 Prod. No.: 001 RX (450MG)

Patents Expiration Patented Use

Pat. No. 7674479 DP* Sustained-release bupropion and bupropion/mecamylamine tablets
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 28, 2011 Jun 25, 2027

ALMATICA
GRALISE (TABLET) (ORAL) GABAPENTIN [Has competitive generic]
Drug Classes: Anticonvulsants:Gamma-aminobutyric Acid (GABA) Augmenting Agents == Central Nervous System Agents:Central Nervous System, Other == antiepileptic drug (AED)
NDA Applicant: ALMATICA NDA No.: 022544 Prod. No.: 001 RX (300MG); 002 RX (600MG)

Patents Expiration Patented Use

Pat. No. 7438927 Methods of treatment using a gastric retained gabapentin dosage
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None Feb 26, 2024 U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia

Pat. No. 7731989 DP* Gastric retained gabapentin dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None Oct 25, 2022

Pat. No. 8192756 DP* Gastric retained gabapentin dosage form
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): All strengths: Jun 8, 2012 Oct 25, 2022 U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia

Pat. No. 8252332 DP* Gastric retained gabapentin dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 17, 2012; 002: None Oct 25, 2022 U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia

Pat. No. 8333992 DP* Gastric retained gabapentin dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 17, 2013; 002: None Oct 25, 2022 U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia

ALMATICA
LOREEV XR (CAPSULE, EXTENDED RELEASE) (ORAL) LORAZEPAM
Drug Classes: Anticonvulsants:Gamma-aminobutyric Acid (GABA) Augmenting Agents == Anxiolytics:Benzodiazepines
NDA Applicant: ALMATICA NDA No.: 214826 Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (3MG); 004 RX (1.5MG)

Patents Expiration Patented Use

Pat. No. 8999393 DP* Sustained release formulations of lorazepam
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 22, 2021; 002: Sep 22, 2021; 003: Sep 22, 2021; 004: Apr 21, 2022 Jan 8, 2034 U-3210: Once daily treatment of anxiety disorder in adults

ALMIRALL
ACZONE (GEL) (TOPICAL) DAPSONE [GENERIC AB]
Drug Classes: Antimycobacterials:Antimycobacterials, Other == Dermatological Agents:Topical Anti-infectives == sulfone
NDA Applicant: ALMIRALL NDA No.: 207154 Prod. No.: 001 RX (7.5%)

Patents Expiration Patented Use

Pat. No. 9161926 DP* Topical dapsone and dapsone/adaplene compositions and methods for use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 1, 2016 Nov 18, 2033

Pat. No. 9517219 Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 16, 2016 Nov 18, 2033 U-1033: Topical treatment of acne vulgaris

Pat. No. 11273132 DP* Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 28, 2022 Nov 18, 2033

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NPP - New patient population Sep 10, 2022

ALMIRALL
ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: Dermatological Agents:Topical Anti-infectives == pleuromutilin antibacterial
NDA Applicant: ALMIRALL NDA No.: 022055 Prod. No.: 001 RX (1%)

Patents Expiration Patented Use

Pat. No. 7875630 DS* Process salts compositions and use
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process
Pat. Sub. Date(s): 001: Feb 10, 2011 Feb 14, 2027

Pat. No. 8207191 Process, salts, composition and use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2016 Aug 30, 2024 U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes

ALMIRALL
KLISYRI (OINTMENT) (TOPICAL) TIRBANIBULIN
NDA Applicant: ALMIRALL NDA No.: 213189 Prod. No.: 001 RX (1%)

Patents Expiration Patented Use

Pat. No. 7300931 DS* DP* Compositions for treating cell proliferation disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 12, 2021 Feb 6, 2026

Pat. No. 7851470 DS* DP* Composition and methods for modulating a kinase cascade
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 12, 2021 Feb 2, 2029 U-3015: Topical treatment of actinic keratosis of the face or scalp

Pat. No. 8236799 DS* DP* Biaryl compositions and methods for modulating a kinase cascade
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 12, 2021 Dec 28, 2025

Pat. No. 8980890 DS* DP* Compositions and methods of treating cell proliferation disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 12, 2021 Dec 28, 2025

Pat. No. 10323001 DP* Compositions for modulating a kinase cascade and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 12, 2021 Dec 28, 2027

Pat. No. 10617693 Methods of treating and/or preventing actinic keratosis
Claim Types: Method of use; Dosaage regimen
Pat. Sub. Date(s): 001: Jan 12, 2021 Mar 12, 2038 U-3015: Topical treatment of actinic keratosis of the face or scalp

Pat. No. 10669236 DS* DP* Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Jan 12, 2021 Sep 7, 2038

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Dec 14, 2025

ALMIRALL
SEYSARA (TABLET) (ORAL) SARECYCLINE HYDROCHLORIDE
Drug Classes: Antibacterials:Tetracyclines == tetracycline-class drug
NDA Applicant: ALMIRALL NDA No.: 209521 Prod. No.: 001 RX (EQ 60MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)

Patents Expiration Patented Use

Pat. No. 8318706 DS* DP* Substituted tetracycline compounds
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: Oct 12, 2018 May 1, 2031 U-2405: A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride

Pat. No. 8513223 Substituted tetracycline compounds for treatment of inflammatory skin disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 12, 2018 Dec 7, 2029 U-2406: A method for treating a patient 9 years of age and older suffering from an inflammatory skin disorder of non-nodular moderate to severe acne vulgaris comprising administering an effective amount of sarecycline hydrochloride

Pat. No. 9255068 DS* DP* Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(met- hyl)amino)-methyl] acid amide and methods of using the same
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 12, 2018 Feb 9, 2033 U-2407: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt
U-2408: A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt

Pat. No. 9481639 Substituted tetracycline compounds for treatment of inflammatory skin disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 12, 2018 Aug 10, 2028 U-2409: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering sarecycline hydrochloride in 60 mg, 100 mg or 150 mg equivalent doses

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Oct 1, 2023

ALMIRALL
VERDESO (AEROSOL, FOAM) (TOPICAL) DESONIDE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == corticosteroid
NDA Applicant: ALMIRALL NDA No.: 021978 Prod. No.: 001 RX (0.05%)

Patents Expiration Patented Use

Pat. No. 8460641 DP* Microemulsion process and composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 5, 2013 Aug 13, 2027 U-1412: Treatment of atopic dermatitis

Pat. No. 8962000 DP* Microemulsion and sub-micron emulsion process and compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 25, 2015 Aug 31, 2025 U-1412: Treatment of atopic dermatitis

Pat. No. 9492384 DP* Microemulsion and sub-micron emulsion process and compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 19, 2016 Aug 31, 2025 U-1412: Treatment of atopic dermatitis

ALNYLAM PHARMS INC
GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 212194 Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))

Patents Expiration Patented Use

Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019 Dec 12, 2029 U-2672: Treatment of acute hepatic porphyria

Pat. No. 8546143 DS* Compositions and methods for inhibiting expression of a target gene
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019 Jan 9, 2022 U-2672: Treatment of acute hepatic porphyria

Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019 Dec 4, 2028 U-2672: Treatment of acute hepatic porphyria

Pat. No. 9133461 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Composition; Isolated cell containing the compound;; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019 May 14, 2033 U-2672: Treatment of acute hepatic porphyria

Pat. No. 9150605 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Claim Types: Composition
Pat. Sub. Date(s): 001: Dec 12, 2019 Aug 28, 2025

Pat. No. 9631193 Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019 Mar 15, 2033 U-2672: Treatment of acute hepatic porphyria

Pat. No. 9708610 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019 Jan 1, 2024 U-2672: Treatment of acute hepatic porphyria

Pat. No. 9708615 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 12, 2019 Mar 8, 2024

Pat. No. 10119143 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Isolated cell contaiing the compound; Composition; Method of use; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Dec 12, 2019 Oct 3, 2034 U-2672: Treatment of acute hepatic porphyria

Pat. No. 10125364 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Isolated cell containing the compound; Composition; Method of use; Intermediate
Pat. Sub. Date(s): 001: Dec 12, 2019 Mar 15, 2033 U-2672: Treatment of acute hepatic porphyria

Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents
Claim Types: Composition; Process; Method of use
Pat. Sub. Date(s): 001: Dec 12, 2019 Aug 24, 2028 U-2672: Treatment of acute hepatic porphyria

Pat. No. 10273477 DS* Therapeutic compositions
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 12, 2019 Mar 8, 2024

Pat. No. 11028392 DS* DP* Compositions and methods for inhibiting expression of the ALAS1 gene
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Feb 16, 2022 Oct 3, 2034 U-2672: Treatment of acute hepatic porphyria

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Nov 20, 2024

Exclusivity Code: ODE - Orphan drug exclusivity Nov 20, 2026 ODE-273: Indicated for the treatment of adults with acute hepatic porphyria (AHP)

ALNYLAM PHARMS INC
ONPATTRO (SOLUTION) (INTRAVENOUS) PATISIRAN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == transthyretin-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 210922 Prod. No.: 001 RX (EQ 10MG BASE/5ML (EQ 2MG BASE/ML))

Patents Expiration Patented Use

Pat. No. 8058069 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 6, 2018 Apr 15, 2029

Pat. No. 8158601 DP* Lipid formulation
Claim Types: Compound; Composition; Formulation; Method of administration
Pat. Sub. Date(s): 001: Sep 6, 2018 Nov 10, 2030 U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Pat. No. 8168775 DS* DP* Compositions and methods for inhibiting expression of transthyretin
Claim Types: Compound; Composition; Intermediate; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018 Oct 20, 2029 U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Pat. No. 8334373 DS* DP* Nuclease resistant double-stranded ribonucleic acid
Claim Types: Compound; Composition; Process
Pat. Sub. Date(s): 001: Sep 6, 2018 May 27, 2025

Pat. No. 8492359 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 6, 2018 Apr 15, 2029

Pat. No. 8642076 DP* Lipid containing formulations
Claim Types: Compound; Formulation
Pat. Sub. Date(s): 001: Sep 6, 2018 Oct 3, 2027

Pat. No. 8741866 Compositions and methods for inhibiting expression of transthyretin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018 Oct 20, 2029 U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Pat. No. 8802644 DP* Lipid formulation
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018 Oct 21, 2030 U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Pat. No. 8822668 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018 Apr 15, 2029 U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Pat. No. 9234196 DP* Compositions and methods for inhibiting expression of transthyretin
Claim Types: Formulation; Intermediate; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018 Oct 20, 2029 U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Pat. No. 9364435 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018 Apr 15, 2029 U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Pat. No. 9943538 DP* 2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 6, 2018 Nov 4, 2023

Pat. No. 9943539 DP* 2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 6, 2018 Nov 4, 2023

Pat. No. 10240152 DS* DP* Compositions and methods for inhibiting expression of transthyretin
Claim Types: Formulation claimed by its inherent performace characteristics; Method of Use claimed by its inherent performace characteristics; Composition
Pat. Sub. Date(s): 001: Sep 3, 2021 Oct 20, 2029 U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Pat. No. 11079379 DS* DP* Methods of treating transthyretin (TTR) mediated amyloidosis
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 3, 2021 Aug 27, 2035 U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Pat. No. 11141378 DP* Lipid formulations for nucleic acid delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 9, 2021 Apr 15, 2029

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Aug 10, 2023

Exclusivity Code: ODE - Orphan drug exclusivity Aug 10, 2025 ODE-197: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

ALNYLAM PHARMS INC
OXLUMO (SOLUTION) (SUBCUTANEOUS) LUMASIRAN SODIUM
NDA Applicant: ALNYLAM PHARMS INC NDA No.: 214103 Prod. No.: 001 RX (EQ 94.5MG/0.5ML BASE (EQ 94.5MG/0.5ML BASE))

Patents Expiration Patented Use

Pat. No. 8106022 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 10, 2020 Dec 12, 2029 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 8828956 DS* DP* Carbohydrate conjugates as delivery agents for oligonucleotides
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 10, 2020 Dec 4, 2028 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 9828606 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 10, 2020 Dec 26, 2034

Pat. No. 10131907 DS* DP* Glycoconjugates of RNA interference agents
Claim Types: Composition; Process; Method of use
Pat. Sub. Date(s): 001: Dec 10, 2020 Aug 24, 2028 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 10435692 Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 10, 2020 Dec 26, 2034 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 10465195 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 10, 2020 Dec 26, 2034 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 10478500 DS* DP* Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Dec 10, 2020 Oct 9, 2035 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 10487330 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 10, 2020 Dec 26, 2034 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 10612024 DS* DP* Modified double-stranded RNA agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 10, 2020 Aug 14, 2035 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 10612027 DS* DP* Modified double-stranded RNA agents
Claim Types: Compound; Composition; Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 10, 2020 Aug 14, 2035 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 11060093 DS* DP* Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2021 Dec 26, 2034 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Pat. No. 11261447 DS* DP* Methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 17, 2022 Nov 20, 2038 U-2995: Treatment of primary hyperoxaluria type 1 (PH1)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Nov 23, 2025

Exclusivity Code: ODE - Orphan drug exclusivity Nov 23, 2027 ODE-339: Treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients

ALPHARMA PHARMS
EMBEDA (CAPSULE, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist
NDA Applicant: ALPHARMA PHARMS NDA No.: 022321 Prod. No.: 001 DISC (20MG;0.8MG); 002 DISC (30MG;1.2MG); 003 DISC (50MG;2MG); 004 DISC (60MG;2.4MG); 005 DISC (80MG;3.2MG); 006 DISC (100MG;4MG)

Patents Expiration Patented Use

Pat. No. 7682633 Pharmaceutical composition
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None Jun 19, 2027 U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed.

Pat. No. 7682634 DP* Pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None Jun 19, 2027

Pat. No. 7815934 DP* Sequestering subunit and related compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 19, 2010; 002: None; 003: None; 004: None; 005: None; 006: None Dec 12, 2027

Pat. No. 8158156 Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: None; 004: None; 005: None; 006: None Jun 19, 2027 U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed.

Pat. No. 8623418 Pharmaceutical composition
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Jan 22, 2015 Nov 7, 2029 U-1640: Treatment of moderate to severe chronic pain by administering an intact composition as claimed

Pat. No. 8685443 Sequestering subunit and related compositions and methods
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None Jul 3, 2025 U-1508: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering a plurality of composite subunits as claimed

Pat. No. 8685444 DP* Sequestering subunit and related compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None Jul 3, 2025

Pat. No. 8846104 DP* Pharmaceutical compositions for the deterrence and/or prevention of abuse
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 28, 2014 Jun 19, 2027

Pat. No. 8877247 DP* Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 1, 2014 Jun 19, 2027

ALTATHERA PHARMS LLC
SOTALOL HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) SOTALOL HYDROCHLORIDE
Drug Classes: Cardiovascular Agents:Antiarrhythmics
NDA Applicant: ALTATHERA PHARMS LLC NDA No.: 022306 Prod. No.: 001 RX (150MG/10ML (15MG/ML))

Patents Expiration Patented Use

Pat. No. 10512620 Method of initiating and escalating sotalol hydrochloride dosing
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 26, 2020 Aug 18, 2038 U-2769: Dosing regimen for intravenous sotalol for administration in a facility that can provide continuous electrocardiographic monitoring and cardiac resuscitation.

Pat. No. 10799138 Method of administering sotalol IV/switch
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 11, 2021 Apr 5, 2039 U-3125: Use for loading dose in patients with symptomatic Afib/AFL who are currently in sinus rhythm or for the treatment of life-threatening ventricular tachycardia

ALTHERA PHARMS
ROSZET (TABLET) (ORAL) EZETIMIBE; ROSUVASTATIN CALCIUM
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == Cardiovascular Agents:Cardiovascular Combinations == dietary cholesterol absorption inhibitor == Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors == HMG CoA-reductase inhibitor
NDA Applicant: ALTHERA PHARMS NDA No.: 213072 Prod. No.: 001 RX (10MG;EQ 5MG BASE); 002 RX (10MG;EQ 10MG BASE); 003 RX (10MG;EQ 20MG BASE); 004 RX (10MG;EQ 40MG BASE)

Patents Expiration Patented Use

Pat. No. 9763885 DP* Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: Mar 29, 2021 May 1, 2033 U-3095: Treatment of hyperlipidemia

Pat. No. 10376470 DP* Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: Mar 29, 2021 May 1, 2033 U-3095: Treatment of hyperlipidemia

ALVOGEN
PYRIMETHAMINE (TABLET) (ORAL) PYRIMETHAMINE [GENERIC AB]
Drug Classes: Antiparasitics:Antiprotozoals == dihydrofolate reductase inhibitor antimalarial
NDA Applicant: ALVOGEN NDA No.: 211271 Prod. No.: 001 RX (25MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Code: CGT - Competitive generic therapy Apr 2, 2022

AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))

Patents Expiration Patented Use

Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 12, 2013 Feb 5, 2024

Pat. No. 7754702 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 12, 2013 Feb 15, 2028 U-1432: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex
U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose

Pat. No. 8895612 Methods and compositions for administration of iron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 17, 2014 Jan 8, 2027 U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less
U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less

Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 18, 2016 Oct 20, 2023

Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Product-by-process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 14, 2021 Oct 20, 2023 U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron

Pat. No. 11291645 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Product-by-process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 27, 2022 Oct 20, 2023 U-3351: Method of treating iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose
U-3352: Method to treat iron deficiency anemia in adults & pediatric patients 1 year and older with intolerance or unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NPP - New patient population Nov 19, 2024

AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 002 RX (500MG IRON/10ML (50MG IRON/ML))

Patents Expiration Patented Use

Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Feb 2, 2021 Feb 5, 2024

Pat. No. 7754702 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 2, 2021 Feb 15, 2028 U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose

Pat. No. 8895612 Methods and compositions for administration of iron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Feb 2, 2021 Jan 8, 2027 U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less
U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less

Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Feb 2, 2021 Oct 20, 2023

Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Product-by-process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 14, 2021 Oct 20, 2023 U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron

Pat. No. 11291645 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Product-by-process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Apr 27, 2022 Oct 20, 2023 U-3351: Method of treating iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose
U-3352: Method to treat iron deficiency anemia in adults & pediatric patients 1 year and older with intolerance or unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NPP - New patient population Nov 19, 2024

AM REGENT
INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation agent == iron replacement product
NDA Applicant: AM REGENT NDA No.: 203565 Prod. No.: 003 RX (1GM IRON/20ML (50MG IRON/ML))

Patents Expiration Patented Use

Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: May 21, 2021 Feb 5, 2024

Pat. No. 7754702 Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 003: May 21, 2021 Feb 15, 2028 U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose

Pat. No. 8895612 Methods and compositions for administration of iron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 003: May 21, 2021 Jan 8, 2027 U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less.
U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less
U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less
U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less
U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less

Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: May 21, 2021 Oct 20, 2023

Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Product-by-process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 14, 2021 Oct 20, 2023 U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron
U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron

Pat. No. 11291645 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them
Claim Types: Product-by-process; Composition; Formulation; Method of use
Pat. Sub. Date(s): 003: Apr 27, 2022 Oct 20, 2023 U-3351: Method of treating iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose
U-3352: Method to treat iron deficiency anemia in adults & pediatric patients 1 year and older with intolerance or unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NPP - New patient population Nov 19, 2024

Exclusivity Code: NS - New strength Apr 28, 2024

AM REGENT
SELENIOUS ACID (SOLUTION) (INTRAVENOUS) SELENIOUS ACID
NDA Applicant: AM REGENT NDA No.: 209379 Prod. No.: 001 RX (EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)); 002 RX (EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)); 003 RX (EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Apr 30, 2024

AM REGENT
TRALEMENT; MULTRYS (SOLUTION) (INTRAVENOUS) CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
NDA Applicant: AM REGENT NDA No.: 209376 Prod. No.: 001 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)); 002 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)); 003 RX (EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NCE - New chemical entity Apr 30, 2024

AMARIN PHARMS
VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other
NDA Applicant: AMARIN PHARMS NDA No.: 202057 Prod. No.: 001 RX (1GM)

Patents Expiration Patented Use

Pat. No. 8293727 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8293728 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8298554 DP* Stable pharmaceutical composition and methods of using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None Apr 29, 2030

Pat. No. 8314086 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8318715 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 29, 2012 Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8357677 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8367652 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 7, 2013 Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8377920 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8399446 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2013 Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8410086 Compositions and methods for lowering triglycerides
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020 Jun 15, 2030 U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy

Pat. No. 8415335 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 17, 2013 Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8426399 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8431560 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8440650 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None Feb 9, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8445003 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None Apr 29, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8445013 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None Apr 29, 2030 U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

Pat. No. 8454994 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020 Apr 29, 2030 U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy

Pat. No.

Patents	Expiration	Patented Use
Pat. No. 6696481 DS* DP* Salt of perindopril and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015	Apr 15, 2023	U-3: Treatment of hypertension
Pat. No. 7846961 DS* DP* .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015	Oct 5, 2029	U-3: Treatment of hypertension

Patents	Expiration	Patented Use
Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017	Nov 10, 2030	U-1524: Reduction of elevated intraocular pressure
Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017	Jul 11, 2026	U-1524: Reduction of elevated intraocular pressure
Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017	Jul 11, 2026	U-1524: Reduction of elevated intraocular pressure
Pat. No. 9415043 DS* Combination therapy Claim Types: Compound Pat. Sub. Date(s): 001: Dec 21, 2017	Mar 14, 2034
Pat. No. 9931336 DS* DP* Combination therapy Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Apr 11, 2018	Mar 14, 2034	U-1524: Reduction of elevated intraocular pressure
Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019	Jan 27, 2030	U-1524: Reduction of elevated intraocular pressure
Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 30, 2020	Jul 11, 2026	U-1524: Reduction of elevated intraocular pressure
Pat. No. 10588901 DS* DP* Combination therapy Claim Types: Formulation; Compound; Method of use Pat. Sub. Date(s): 001: Apr 15, 2020	Mar 14, 2034	U-1524: Reduction of elevated intraocular pressure
Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: Jun 10, 2020	Jan 27, 2030	U-1524: Reduction of elevated intraocular pressure
Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2021	Jul 11, 2026	U-1524: Reduction of elevated intraocular pressure
Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021	Jul 11, 2026	U-1524: Reduction of elevated intraocular pressure
Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021	Jan 27, 2030	U-1524: Reduction of elevated intraocular pressure
Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Dec 16, 2021	Mar 14, 2034
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Dec 18, 2022

Patents	Expiration	Patented Use
Pat. No. 8246978 DP* Dermal delivery device with reduced loss of its volatile components Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Mar 10, 2020	Aug 26, 2028
Pat. No. 8747888 DP* Dermal delivery device with in situ seal Claim Types: Device; Formulation Pat. Sub. Date(s): 001: Mar 10, 2020	Jul 10, 2028
Pat. No. 9050348 DP* Dermal delivery device Claim Types: Device Pat. Sub. Date(s): 001: Mar 10, 2020	Jul 10, 2028
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Feb 14, 2023

Patents	Expiration	Patented Use
Pat. No. 8785450 DS* DP* Therapeutic compounds and compositions Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Mar 8, 2022	Feb 24, 2031
Pat. No. 9193701 Pyruvate kinase activators for use in therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022	Oct 26, 2032	U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
Pat. No. 9682080 Pyruvate kinase activators for use in therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022	May 3, 2032	U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
Pat. No. 9980961 Pyruvate kinase activators for use in therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022	May 3, 2032	U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
Pat. No. 10632114 Pyruvate kinase activators for use in therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022	May 3, 2032	U-3320: Method for increasing the lifetime of red blood cells (RBCS) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
Pat. No. 11234976 Methods of using pyruvate kinase activators Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2022	Oct 11, 2038	U-3321: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency by administering a daily dose of 10mg to 100mg
Pat. No. 11254652 DS* DP* Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfon- amide Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Mar 8, 2022	Nov 21, 2038
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Feb 17, 2027

Patents	Expiration	Patented Use
Pat. No. 7638536 DS* DP* 2-Acylaminothiazole derivative or salt thereof Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 15, 2018	May 5, 2025
Pat. No. 8338429 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019	Jun 30, 2023	U-2577: Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment
Pat. No. 8765764 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 15, 2018	Jan 15, 2023	U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET U-2578: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jun 26, 2022	I-802: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment
Exclusivity Code: NCE - New chemical entity	May 21, 2023
Exclusivity Code: ODE - Orphan drug exclusivity	Jun 26, 2026	ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

Patents	Expiration	Patented Use
Pat. No. 7015315 DS* Gapped oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018	Mar 21, 2023
Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018	Sep 5, 2023
Pat. No. 8101743 DS* DP* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018	Apr 1, 2025
Pat. No. 8697860 DP* Diagnosis and treatment of disease Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2018	Apr 29, 2031
Pat. No. 9061044 DS* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018	Apr 29, 2031
Pat. No. 9399774 Modulation of transthyretin expression Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 1, 2018	Apr 29, 2031	U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Oct 5, 2023
Exclusivity Code: ODE - Orphan drug exclusivity	Oct 5, 2025	ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

Patents	Expiration	Patented Use
Pat. No. 7132416 DS* DP* Benzothiazepine and benzothiazepine derivatives with ileal bile acid transport (IBAT) inhibotory activity for the treatment hyperlipidaemia Claim Types: Compound; Process; Composition Pat. Sub. Date(s): All strengths: Aug 18, 2021	Sep 5, 2022
Pat. No. 9694018 IBAT inhibitors for the treatment of liver disease Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021	Nov 8, 2031	U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 10011633 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021	Nov 8, 2031	U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 10093697 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021	Nov 8, 2031	U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 10487111 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021	Nov 8, 2031	U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 10975046 DS* Crystal modifications of odevixibat Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Aug 18, 2021	Jun 20, 2039
Pat. No. 10981952 IBAT inhibitors for the treatment of liver diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 18, 2021	Nov 8, 2031	U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 20, 2026
Exclusivity Code: ODE - Orphan drug exclusivity	Jul 20, 2028	ODE-363: Treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC)

Patents	Expiration	Patented Use
Pat. No. 8791154 DP* High concentration olopatadine ophthalmic composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 31, 2015	May 19, 2032	U-1680: Treatment of ocular itching associated with allergic conjunctivitis
Pat. No. 9533053 DP* High concentration olopatadine ophthalmic composition Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 31, 2020	May 19, 2032

Patents	Expiration	Patented Use
Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2015	Oct 30, 2030
Pat. No. 9421265 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 24, 2016	Jun 17, 2030

Patents	Expiration	Patented Use
Pat. No. 6716416 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013	May 20, 2022
Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013	Aug 18, 2024
Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013	Oct 28, 2024
Pat. No. 8074644 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013	Jul 25, 2022
Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013	Oct 23, 2026
Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Apr 29, 2015	May 21, 2024
Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Jul 7, 2016	May 20, 2024

Patents	Expiration	Patented Use
Pat. No. 8318817 Controlled release antimicrobial compositions and methods for the treatment of otic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 11, 2016	Apr 27, 2030	U-1792: Treatment of otic infection or inflammation
Pat. No. 9205048 Controlled release antimicrobial compositions and methods for the treatment of otic disorders Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 11, 2016	Apr 21, 2029	U-1793: Treatment of pediatric patients with otitis media with effusion undergoing tympanostomy tube placement
Pat. No. 9220796 DP* Sterilization of ciprofloxacin composition Claim Types: Product-by-process; Drug in a container; Process Pat. Sub. Date(s): 001: Jan 11, 2016	Jul 1, 2035
Pat. No. 9233068 DP* Controlled release antimicrobial compositions and methods for the treatment of OTIC disorders Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 5, 2016	Dec 11, 2029
Pat. No. 9603796 DS* DP* Controlled release antimicrobial compositions and methods for the treatment of otic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 26, 2018	Apr 21, 2029	U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus
Pat. No. 11040004 Otic gel formulations for treating otitis externa Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 21, 2021	Nov 12, 2037	U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus
Pat. No. 11246863 DP* Ciprofloxacin otic composition and kits and method for using same Claim Types: Kit Pat. Sub. Date(s): 001: Mar 11, 2022	Nov 27, 2038

Patents	Expiration	Patented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017	Oct 26, 2030
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017	Jun 24, 2030	U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017	Nov 7, 2032	U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017	Oct 24, 2033	U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017	Mar 19, 2035	U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Nov 20, 2018	Jun 24, 2030	U-543: Treatment of schizophrenia
Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019	Mar 19, 2032	U-543: Treatment of schizophrenia
Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): All strengths: Apr 8, 2019	Mar 19, 2035	U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 Aripiprazole formulations having increased injection speeds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 10, 2020	Mar 19, 2035	U-2983: Treatment of schizophrenia by rapid and continuous injection
Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2021	Oct 24, 2033	U-764: Treatment of schizophrenia
Pat. No. 11273158 Aripiprazole dosing strategy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 13, 2022	Apr 6, 2039	U-543: Treatment of schizophrenia

Patents	Expiration	Patented Use
Pat. No. 7262298 DS* 4-hydroxybenzomorphans Claim Types: Compound Pat. Sub. Date(s): All strengths: Jun 25, 2021	Nov 23, 2025
Pat. No. 8778960 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021	Feb 13, 2032	U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
Pat. No. 9119848 DS* Morphinan derivatives for the treatment of drug overdose Claim Types: Method of use; Compound Pat. Sub. Date(s): All strengths: Jun 25, 2021	Aug 30, 2031
Pat. No. 9126977 DP* Methods for treating antipsychotic-induced weight gain Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: Jun 25, 2021	Aug 23, 2031	U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
Pat. No. 9517235 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021	Aug 23, 2031	U-3138: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile U-3139: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile
Pat. No. 10300054 DP* Methods for treating antipsychotic-induced weight gain Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021	Aug 23, 2031	U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan U-3141: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan
Pat. No. 10716785 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2021	Aug 23, 2031	U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
Pat. No. 11185541 Methods for treating antipsychotic-induced weight gain Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 22, 2021	Aug 23, 2031	U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan
Pat. No. 11241425 Composition for treating mental illness Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Mar 3, 2022	Aug 23, 2031	U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	May 28, 2026

Patents	Expiration	Patented Use
Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 23, 2011	Nov 24, 2027 *PED	U-1181: A method of treating or preventing ocular pain in a patient
Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2012	Nov 28, 2024 *PED	U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient
Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 18, 2013	Nov 28, 2024 *PED	U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery
Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2013	Nov 28, 2024 *PED	U-1441: A method of treating or reducing ocular pain and burning/stinging
Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2014	May 28, 2024
Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2015	May 28, 2024	U-1626: A method of treating or preventing ocular pain and burning
Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 4, 2015	May 28, 2024	U-1662: A method of treating ocular pain
Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016	May 28, 2024	U-1800: A method of treating ocular pain and/or enhancing ocular comfort

Patents	Expiration	Patented Use
Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010	Aug 15, 2029
Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 19, 2013	Mar 7, 2028
Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2015	Aug 5, 2024
Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015	Mar 7, 2028

Patents	Expiration	Patented Use
Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 10, 2022 *PED
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 18, 2022 *PED
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 28, 2022 *PED
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 26, 2022 *PED
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016	Jan 10, 2022 *PED	U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension

Patents	Expiration	Patented Use
Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 10, 2022 *PED
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 18, 2022 *PED
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 28, 2022 *PED
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 26, 2022 *PED
Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 13, 2014	Mar 2, 2024 *PED
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016	Jan 10, 2022 *PED	U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2017	Jan 10, 2022 *PED

Patents	Expiration	Patented Use
Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015	Jan 7, 2026	U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pnenumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium U-282: Method of treating bacterial infections
Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015	Nov 12, 2026
Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Mar 17, 2015	Aug 12, 2031
Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015	Oct 8, 2030
Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Mar 17, 2015	Jun 15, 2032
Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 24, 2017	Jun 15, 2032
Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Formulation; Compound; Composition Pat. Sub. Date(s): 001: Aug 8, 2017	Jun 15, 2032
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Feb 25, 2025 GAIN

Patents	Expiration	Patented Use
Pat. No. 7803838 DP* Compositions comprising nebivolol Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 5, 2016	Aug 29, 2026
Pat. No. 7838552 Compositions comprising nebivolol Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 5, 2016	Oct 4, 2027	U-185: Method of treating hypertension

Patents	Expiration	Patented Use
Pat. No. 8217083 DP* Mesalamine suppository Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2013	Jun 6, 2028
Pat. No. 8436051 DP* Mesalamine suppository Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2013	Jun 6, 2028

Patents	Expiration	Patented Use
Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None	Apr 19, 2022	U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily
Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None	Apr 19, 2022	U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily
Pat. No. 7642258 DS* DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: None	Apr 19, 2022	U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP
Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 2, 2012	Apr 19, 2022	U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Mar 27, 2013	Apr 19, 2022	U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma
Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 7, 2014	Apr 19, 2022	U-1524: Reduction of elevated intraocular pressure
Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2016	Apr 19, 2022	U-1524: Reduction of elevated intraocular pressure
Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 12, 2017	Apr 19, 2022	U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid
Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018	Apr 19, 2022	U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid
Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018	Apr 19, 2022	U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid

Patents	Expiration	Patented Use
Pat. No. 6900175 Methods of administering dalbavancin for treatment of bacterial infections Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 13, 2014	Dec 25, 2023	U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin.
Pat. No. 7115564 DP* Stable pharmaceutical compositions of dalbavancin and methods of administration Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014	Nov 14, 2023
Pat. No. 7119061 DP* Dalbavancin compositions for treatment of bacterial infections Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014	Nov 14, 2023
Pat. No. 8143212 Dalbavancin compositions for treatment of bacterial infections Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 13, 2014	Nov 14, 2023	U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin.
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	May 23, 2024 GAIN
Exclusivity Code: NPP - New patient population	Jul 22, 2024

Patents	Expiration	Patented Use
Pat. No. RE43879 Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2013	Jan 11, 2026	U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8481598 Stable dosage forms of levomilnacipran Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Aug 15, 2013	Mar 2, 2031	U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8865937 DS* DP* Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Nov 20, 2014	May 23, 2032
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Oct 7, 2022	M-249: Information added to the labeling to describe study LVM-MD-15 to fulfill postmarketing commitment 1943-4

Patents	Expiration	Patented Use
Pat. No. 8920392 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Drug in a container; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 27, 2015	Mar 26, 2031	U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin
Pat. No. 9259388 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 16, 2016	Nov 6, 2029	U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin
Pat. No. 10449173 DP* Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 30, 2019	Nov 6, 2029	U-2637: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence with a single unit dose of 10% oxybutynin chloride gel

Patents	Expiration	Patented Use
Pat. No. 8664215 Ocular allergy treatments with alcaftadine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2014	Dec 23, 2027	U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander
Pat. No. 10617695 DP* Ophthalmic compositions containing alcaftadine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 12, 2020	Mar 19, 2027	U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander

Patents	Expiration	Patented Use
Pat. No. 8038988 DS* DP* Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 31, 2011	Aug 25, 2023	U-1208: Treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness
Pat. No. 8101161 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012	May 25, 2024	U-1217: Method of increasing hair growth U-1218: Method of stimulating hair growth
Pat. No. 8263054 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 17, 2012	Jan 15, 2023	U-1277: Method of increasing eyelash growth including length, thickness, darkness and/or number of eyelashes by administering bimatoprost to an eyelid margin
Pat. No. 8632760 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2014	Jan 15, 2023	U-1487: Method of increasing eyelash growth
Pat. No. 8758733 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 16, 2014	Jan 15, 2023	U-1487: Method of increasing eyelash growth
Pat. No. 8986715 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 1, 2015	Jan 15, 2023	U-1217: Method of increasing hair growth
Pat. No. 9216183 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016	Jan 15, 2023	U-1487: Method of increasing eyelash growth
Pat. No. 9226931 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016	Jan 15, 2023	U-1799: Method of increasing growth of hair including eyelashes

Patents	Expiration	Patented Use
Pat. No. 6916941 DS* DP* Crystalline composition containing escitalopram Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation Pat. Sub. Date(s): All strengths: None	Feb 12, 2023 *PED
Pat. No. 7420069 DP* Crystalline composition containing escitalopram Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: None	Feb 12, 2023 *PED

Patents	Expiration	Patented Use
Pat. No. *7304036* DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 001: Sep 18, 2012	Aug 30, 2026	U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 18, 2012	Jan 28, 2024
Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012	Jan 28, 2024
Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012	Jan 28, 2024
Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012	Jan 28, 2024
Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 18, 2012	Jan 28, 2024	U-1278: Method of treating irritable bowel syndrome with constipation in adults
Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 11, 2014	Oct 30, 2031	U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 19, 2014	Oct 30, 2031
Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 6, 2015	Feb 17, 2031
Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 10, 2017	Aug 16, 2033	U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients.

Patents	Expiration	Patented Use
Pat. No. *7304036* DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 003: Feb 24, 2017	Aug 30, 2026	U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 003: Feb 24, 2017	Jan 28, 2024
Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017	Jan 28, 2024
Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017	Jan 28, 2024
Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017	Jan 28, 2024
Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 003: Feb 24, 2017	Jan 28, 2024	U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Feb 24, 2017	Feb 17, 2031	U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Aug 10, 2017	Aug 16, 2033	U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 10675325 DP* Stable formulations of linaclotide Claim Types: Composition Pat. Sub. Date(s): 003: Jun 22, 2020	Aug 11, 2031
Pat. No. 10702576 Stable formulations of linaclotide Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 4, 2020	Aug 11, 2031	U-1516: Method of treating chronic idiopathic constipation in adult patients.

Patents	Expiration	Patented Use
Pat. No. 7851504 DS* DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jun 13, 2027
Pat. No. 8278353 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2012	Mar 16, 2025
Pat. No. 8299118 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2012	Mar 16, 2025	U-1295: A method of treating a patient with glaucoma or ocular hypertension
Pat. No. 8309605 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2012	Mar 16, 2025	U-1293: A method of lowering intraocular pressure in a patient with open angle glaucoma or ocular hypertension U-1294: Method of treating glaucoma in a patient
Pat. No. 8338479 DP* Enhanced bimatoprost ophthalmic solution Claim Types: ;Composition; Method of administration Pat. Sub. Date(s): 001: Dec 26, 2012	Mar 16, 2025	U-1295: A method of treating a patient with glaucoma or ocular hypertension
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Pat. No. 8586630 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: None	Mar 16, 2025	U-1458: A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 8772338 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 21, 2014	Mar 16, 2025	U-1528: A method of lowering intraocular pressure
Pat. No. 8933120 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 10, 2015	Mar 16, 2025
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Pat. No. 9155716 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2015	Mar 16, 2025	U-1528: A method of lowering intraocular pressure
Pat. No. 9241918 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 24, 2016	Mar 16, 2025	U-1814: Method of treating glaucoma or elevated intraocular pressure