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.
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. |
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 |
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 |
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 |
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) |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
ABBVIE INC
RINVOQ (TABLET, EXTENDED RELEASE)
(ORAL) UPADACITINIB
Drug Classes:
Immunological
Agents:Immunological Agents, Other
NDA Applicant:
ABBVIE
INC NDA No.: 211675 Prod. No.:
003 RX (45MG)
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 |
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) |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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
VRAYLAR (CAPSULE) (ORAL)
CARIPRAZINE HYDROCHLORIDE
Drug Classes:
Antipsychotics:2nd
Generation/Atypical == atypical antipsychotic
NDA Applicant:
ALLERGAN NDA No.:
204370 Prod. No.:
002 RX (EQ 3MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
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): 002: 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): 002: 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
VRAYLAR (CAPSULE) (ORAL)
CARIPRAZINE HYDROCHLORIDE
Drug Classes:
Antipsychotics:2nd
Generation/Atypical == atypical antipsychotic
NDA Applicant:
ALLERGAN NDA No.:
204370 Prod. No.:
003 RX (EQ 4.5MG BASE); 004 RX (EQ 6MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
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): All strengths: 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 |
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): All strengths: 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
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.:
004 RX (100MG IRON/2ML (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): 004: Mar 4, 2022 |
Feb 5, 2024 | |
Pat.
No. 7754702
Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Mar 4, 2022 |
Feb 15, 2028 | 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): 004: Mar 4, 2022 |
Jan 8, 2027 | 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): 004: Mar 4, 2022 |
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): 004: Mar 4, 2022 |
Oct 20, 2023 | 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): 004: 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 |
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. |