Orange Book Companion
Company names starting with "A"

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


AAA USA INC
LUTATHERA (SOLUTION) (INTRAVENOUS) LUTETIUM DOTATATE LU-177
NDA Applicant: AAA USA INC      NDA No.: 208700  Prod. No.: 001 RX (10mCi/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 26, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityJan 26, 2025ODE-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 1, 2021 
Exclusivity Code: ODE - Orphan drug exclusivityJun 1, 2023ODE-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.

ABBVIE
ANDROGEL (GEL; GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB1]
Drug Classes: androgen
NDA Applicant: ABBVIE      NDA No.: 021015  Prod. No.: 001 RX (25MG/2.5GM PACKET); 002 RX (50MG/5GM PACKET); 003 RX (12.5MG/1.25GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Formulation; Device; Method of administration
Pat. Sub. Date(s): All strengths: None
Mar 1, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 14, 2015
Mar 2, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 28, 2015
Mar 2, 2021 *PEDU-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

ABBVIE
ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: ABBVIE      NDA No.: 022309  Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)); 002 RX (1.62% (20.25MG/1.25GM PACKET)); 003 RX (1.62% (40.5MG/2.5GM PACKET))
PatentsExpirationPatented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Formulation; Device; Method of administration
Pat. Sub. Date(s): 001: None; 002: May 23, 2014; 003: May 23, 2014
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
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, 2026U-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, 2026U-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, 2026U-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 
Pat. No. 9125816 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 14, 2015
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 9132089 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 28, 2015
Mar 2, 2021 *PEDU-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

ABBVIE
CALCIJEX (INJECTABLE) (INJECTION) CALCITRIOL
Drug Classes: vitamin D3 analog
NDA Applicant: ABBVIE      NDA No.: 018874  Prod. No.: 001 DISC (0.001MG/ML**); 002 DISC (0.002MG/ML**)
PatentsExpirationPatented Use
Pat. No. 6051567 Low oxygen content compositions of 1.alpha., 25-dihydroxycholecalciferol
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 2, 2020 *PED 
Pat. No. 6265392 Low oxygen content compositions of 1.alpha., 25-dihydroxycholeclciferol
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 2, 2020 *PED 
Pat. No. 6274169 Low oxygen content compostions of 1.alpha., 25-dihydroxycholecalciferol
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Feb 2, 2020 *PED 

ABBVIE
CREON (CAPSULE, DELAYED RELEASE) (ORAL) PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Drug Classes: intestinal lipase inhibitor; hydrolytic lysosomal cholesteryl ester-specific enzyme; hydrolytic lysosomal triacylglycerol-specific enzyme
NDA Applicant: ABBVIE      NDA No.: 020725  Prod. No.: 001 RX (30,000USP UNITS;6,000USP UNITS;19,000USP UNITS); 002 RX (60,000USP UNITS;12,000USP UNITS;38,000USP UNITS); 003 RX (120,000USP UNITS;24,000USP UNITS;76,000USP UNITS)
PatentsExpirationPatented Use
Pat. No. 9198871 DP* Delayed release pancreatin compositions
Claim Types: Method of use; Product-by-process; Formulation; Process
Pat. Sub. Date(s): All strengths: Dec 22, 2015
Feb 7, 2030U-1787: Treatment of exocrine pancreatic insufficiency

ABBVIE
CREON (CAPSULE, DELAYED RELEASE) (ORAL) PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
Drug Classes: intestinal lipase inhibitor; hydrolytic lysosomal cholesteryl ester-specific enzyme; hydrolytic lysosomal triacylglycerol-specific enzyme
NDA Applicant: ABBVIE      NDA No.: 020725  Prod. No.: 004 RX (15,000USP UNITS;3,000USP UNITS;9,500USP UNITS); 005 RX (180,000USP UNITS;36,000USP UNITS;114,000USP UNITS)
PatentsExpirationPatented Use
Pat. No. 9198871 DP* Delayed release pancreatin compositions
Claim Types: Method of use; Product-by-process; Formulation; Process
Pat. Sub. Date(s): All strengths: Dec 22, 2015
Feb 7, 2030U-1787: Treatment of exocrine pancreatic insufficiency
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJul 29, 2019M-93: Expansion of labeling to include information on safety and efficacy of CREON in patients ages 7 years through 11 years with pancreatic exocrine insufficiency due to cystic fibrosis

ABBVIE
DEPAKOTE ER (TABLET, EXTENDED RELEASE) (ORAL) DIVALPROEX SODIUM [GENERIC AB]
NDA Applicant: ABBVIE      NDA No.: 021168  Prod. No.: 001 RX (EQ 500MG VALPROIC ACID)
PatentsExpirationPatented Use
Pat. No. 6419953 Controlled release formulation of divalproex sodium
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Jun 18, 2019 *PED 
Pat. No. 6511678 Controlled release formulation of divalproex sodium
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jun 18, 2019 *PED 
Pat. No. 6528090 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jun 18, 2019 *PED 
Pat. No. 6528091 Controlled release formulation of divalproex sodium
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jun 18, 2019 *PEDU-106: Treatment of epilepsy
Pat. No. 6713086 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jun 18, 2019 *PEDU-579: Treatment of epilepsy and/or migraine.
Pat. No. 6720004 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jun 18, 2019 *PED 

ABBVIE
DEPAKOTE ER (TABLET, EXTENDED RELEASE) (ORAL) DIVALPROEX SODIUM [GENERIC AB]
NDA Applicant: ABBVIE      NDA No.: 021168  Prod. No.: 002 RX (EQ 250MG VALPROIC ACID)
PatentsExpirationPatented Use
Pat. No. 6511678 Controlled release formulation of divalproex sodium
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Jun 18, 2019 *PED 
Pat. No. 6528090 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jun 18, 2019 *PED 
Pat. No. 6713086 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Jun 18, 2019 *PEDU-579: Treatment of epilepsy and/or migraine.
Pat. No. 6720004 DP* Controlled release formulation of divalproex sodium
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jun 18, 2019 *PED 

ABBVIE
KALETRA (CAPSULE) (ORAL) LOPINAVIR; RITONAVIR
Drug Classes: HIV protease inhibitor; CYP3A inhibitor
NDA Applicant: ABBVIE      NDA No.: 021226  Prod. No.: 001 DISC (133.3MG;33.3MG)
PatentsExpirationPatented Use
Pat. No. 7141593 DP* Pharmaceutical formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 22, 2020 *PED 
Pat. No. 7432294 DP* Pharmaceutical formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 22, 2020 *PED 

ABBVIE
KALETRA (SOLUTION) (ORAL) LOPINAVIR; RITONAVIR [GENERIC AA]
Drug Classes: HIV protease inhibitor; CYP3A inhibitor
NDA Applicant: ABBVIE      NDA No.: 021251  Prod. No.: 001 RX (80MG/ML;20MG/ML)
PatentsExpirationPatented Use
Pat. No. 6911214 DP* Flavoring systems for pharmaceutical compositions and methods of making such compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 28, 2022 *PEDU-895: Treatment of HIV infection in combination with other antiretroviral agents
Pat. No. 8501219 DP* Flavoring systems for pharmaceutical compositions and methods of making such compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 26, 2013
Nov 28, 2021 

ABBVIE
KALETRA (TABLET) (ORAL) LOPINAVIR; RITONAVIR
Drug Classes: HIV protease inhibitor; CYP3A inhibitor
NDA Applicant: ABBVIE      NDA No.: 021906  Prod. No.: 001 RX (200MG;50MG); 002 RX (100MG;25MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: None
Jan 19, 2020 *PED 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
May 10, 2021 *PEDU-688: Treatment of HIV-infection in combination with other antiretroviral agents
Pat. No. 8025899 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 11, 2011; 002: None
Jun 14, 2028 *PED 
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 25, 2025 *PED 
Pat. No. 8309613 Solid pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 5, 2012; 002: None
Jun 24, 2025 *PEDU-688: Treatment of HIV-infection in combination with other antiretroviral agents
Pat. No. 8377952 Solid pharmaceutical dosage formulation
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 18, 2013; 002: None
Apr 22, 2028 *PEDU-1372: Administration without food for treatment of HIV-1 infection
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 5, 2013; 002: None
Feb 25, 2025 *PED 
Pat. No. 8470347 DP* Self-emulsifying active substance formulation and use of this formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 12, 2013; 002: None
Mar 17, 2027 *PED 
Pat. No. 8691878 Solid pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 10, 2014
Feb 25, 2025 *PEDU-1513: Treatment of HIV-1 infection in combination with other antiretroviral agents

ABBVIE
NORVIR (CAPSULE) (ORAL) RITONAVIR
Drug Classes: CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE      NDA No.: 020945  Prod. No.: 001 DISC (100MG)
PatentsExpirationPatented Use
Pat. No. 7141593 DP* Pharmaceutical formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 22, 2020 *PED 
Pat. No. 7432294 DP* Pharmaceutical formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 22, 2020 *PED 

ABBVIE
NORVIR (TABLET) (ORAL) RITONAVIR [GENERIC AB]
Drug Classes: CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE      NDA No.: 022417  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: None
Jan 19, 2020 *PED 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
May 10, 2021 *PEDU-688: Treatment of HIV-infection in combination with other antiretroviral agents
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 26, 2012
Feb 25, 2025 *PED 
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 8, 2013
Feb 25, 2025 *PED 
Pat. No. 8470347 DP* Self-emulsifying active substance formulation and use of this formulation
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 12, 2013
Mar 17, 2027 *PED 
Pat. No. 8691878 Solid pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2014
Feb 25, 2025 *PEDU-688: Treatment of HIV-infection in combination with other antiretroviral agents

ABBVIE
TRICOR (TABLET) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: ABBVIE      NDA No.: 021656  Prod. No.: 001 RX (48MG); 002 RX (145MG)
PatentsExpirationPatented Use
Pat. No. 6375986 DP* Solid dose nanoparticulate compositions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: None
Sep 21, 2020U-615: Adjunctive therapy to diet in adults to reduce LDL-c, total-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)
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, 2023U-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)
PatentsExpirationPatented 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 (CAPSULE) (ORAL) PARICALCITOL [GENERIC AB]
Drug Classes: vitamin D3 analog
NDA Applicant: ABBVIE      NDA No.: 021606  Prod. No.: 001 RX (1MCG); 002 RX (2MCG) NDA No.: 021606  Prod. No.: 003 DISC (4MCG**)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationOct 18, 2019 
Exclusivity Code: ODE - Orphan drug exclusivityOct 18, 2023ODE-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: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC      NDA No.: 020517  Prod. No.: 003 RX (45MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7429559 DP* Controlled release composition and method of producing the same
Claim Types: Formulation
Pat. Sub. Date(s): 003: Jul 13, 2011
Jan 13, 2019 
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, 2031U-1666: Palliative treatment of prostate cancer

ABBVIE INC
DUOPA (SUSPENSION) (ENTERAL) CARBIDOPA; LEVODOPA
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 203952  Prod. No.: 001 RX (4.63MG/ML;20MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 9, 2022ODE-84: Treatment of motor fluctuations in patients with advanced Parkinson's disease

ABBVIE INC
MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: 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)
PatentsExpirationPatented Use
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
Jan 19, 2032U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 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
May 18, 2032 
Pat. No. 9321807 DS* Crystal forms
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Aug 29, 2017
Jun 5, 2035 
Pat. No. 9586978 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 29, 2017
Jun 10, 2030U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 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
Jun 10, 2030U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 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
Jun 10, 2030U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 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
Mar 14, 2034U-2532: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAug 6, 2021M-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: NCE - New chemical entityAug 3, 2022 
Exclusivity Code: NPP - New patient populationApr 30, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityApr 30, 2026ODE-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 exclusivityApr 30, 2026ODE-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

ABBVIE INC
NORVIR (POWDER) (ORAL) RITONAVIR
Drug Classes: CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 209512  Prod. No.: 001 RX (100MG/PACKET)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJun 7, 2024ODE-184: Indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection

ABBVIE INC
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
NDA Applicant: ABBVIE INC      NDA No.: 210450  Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 200MG BASE)
PatentsExpirationPatented Use
Pat. No. 6872728 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Aug 20, 2018
Jan 25, 2021 
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: 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): All strengths: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7179815 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 20, 2018
Mar 7, 2021U-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): All strengths: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7462625 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Aug 20, 2018
Jan 25, 2021U-2360: Management of moderate to severe pain associated with endometriosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 23, 2023 

ABBVIE INC
TECHNIVIE (TABLET) (ORAL) OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus (HCV) NS5A inhibitor; hepatitis C virus (HCV) NS3/4A protease inhibitor; CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 207931  Prod. No.: 001 DISC (12.5MG;75MG;50MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015
Jan 19, 2020 *PED 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
May 10, 2021 *PED 
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, 2029U-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, 2030U-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, 2031U-1638: Treatment of HCV infection using paritaprevir
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 19, 2019 

ABBVIE INC
VENCLEXTA (TABLET) (ORAL) VENETOCLAX
Drug Classes: BCL-2 inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 208573  Prod. No.: 001 RX (10MG); 002 RX (50MG); 003 RX (100MG)
PatentsExpirationPatented 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. 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, 2030U-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, 2033U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 8, 2021I-782: Revisions to indication 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: I - New IndicationNov 21, 2021I-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 IndicationMay 15, 2022I-795: Venetoclax in combination with obinutuzumab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
Exclusivity Code: M - MiscellaneousJun 8, 2021M-228: Information added to the package insert regarding the revision of the monotherapy indication of venetoclax
Exclusivity Code: NCE - New chemical entityApr 11, 2021 
Exclusivity Code: ODE - Orphan drug exclusivityApr 11, 2023ODE-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 exclusivityJun 8, 2025ODE-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 exclusivityNov 21, 2025ODE-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 exclusivityMay 15, 2026ODE-239: Treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

ABBVIE INC
VIEKIRA PAK (COPACKAGED) (TABLET, TABLET) (ORAL) DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor; hepatitis C virus (HCV) NS3/4A protease inhibitor; CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 206619  Prod. No.: 001 RX (EQ 250MG BASE,N/A,N/A,N/A; N/A,12.5MG,75MG,50MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Jul 19, 2019 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Nov 10, 2020 
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, 2029U-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, 2032U-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, 2032U-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, 2028U-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, 2029U-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, 2032U-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, 2032U-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, 2030U-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, 2031U-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, 2028U-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, 2033U-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, 2033U-1753: Treatment of HCV infection using dasabuvir
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleApr 22, 2019D-163: Dosing to include patients with chronic HCV genotype 1a infection with compensated (Child-Pugh A) cirrhosis and genotype 1B with or without compensated (Child-Pugh A) cirrhosis
Exclusivity Code: NCE - New chemical entityDec 19, 2019 

ABBVIE INC
VIEKIRA XR (TABLET, EXTENDED RELEASE) (ORAL) DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor; hepatitis C virus (HCV) NS5A inhibitor; hepatitis C virus (HCV) NS3/4A protease inhibitor; CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 208624  Prod. No.: 001 DISC (EQ 200MG BASE;8.33MG;50MG;33.33MG)
PatentsExpirationPatented Use
Pat. No. 7148359 DP* Polymorph of a pharmaceutical
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 17, 2016
Jul 19, 2019 
Pat. No. 7364752 DP* Solid dispersion pharamaceutical formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Nov 10, 2020 
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, 2029U-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, 2032U-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, 2032U-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, 2028U-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, 2029U-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, 2032U-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, 2032U-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, 2030U-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, 2031U-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, 2028U-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, 2035U-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, 2035U-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, 2035U-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, 2032U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 19, 2019 

ABRAXIS BIOSCIENCE
ABRAXANE (FOR SUSPENSION) (IV (INFUSION)) PACLITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: ABRAXIS BIOSCIENCE      NDA No.: 021660  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented 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
Feb 21, 2026U-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
Oct 27, 2024U-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
Dec 9, 2023U-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
Aug 13, 2026U-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
Dec 9, 2023U-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
Feb 21, 2026U-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
Dec 9, 2023U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8853260 DP* Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 14, 2014
Oct 10, 2020U-1092: Treatment of breast cancer
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
Feb 21, 2026U-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
Mar 4, 2032U-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
Jan 12, 2034U-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
Mar 4, 2032U-1290: Treatment of lung cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 6, 2020ODE-52: Treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.: 207318  Prod. No.: 001 DISC (EQ 17MG BASE)
PatentsExpirationPatented Use
Pat. No. 6756393 DS* DP* Azacyclic compounds
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 25, 2016
Mar 6, 2021 
Pat. No. 6815458 DS* DP* Azacyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: May 25, 2016
Mar 6, 2021U-1843: Treatment of psychosis
Pat. No. 7115634 DS* DP* 4-aminopiperidine and their use as a medicine
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 25, 2016
Oct 6, 2021 
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
Jun 17, 2027 
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, 2026U-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. 7858789 DS* DP* Derivatives of 4-aminopiperidine and their use as a medicament
Claim Types: Compound
Pat. Sub. Date(s): 001: May 25, 2016
Dec 13, 2020 
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. 8110574 DS* DP* Derivatives of 4-aminopiperidine and their use as a medicament
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: May 25, 2016
Dec 13, 2020 
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, 2024U-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, 2024U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9296694 DS* DP* Azacyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 001: May 25, 2016
Mar 6, 2021 
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, 2024U-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, 2022U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 29, 2021 

ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.: 207318  Prod. No.: 002 RX (EQ 10MG BASE)
PatentsExpirationPatented Use
Pat. No. 6756393 DS* DP* Azacyclic compounds
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: Jul 25, 2018
Mar 6, 2021 
Pat. No. 6815458 DS* DP* Azacyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Mar 6, 2021U-1843: Treatment of psychosis
Pat. No. 7115634 DS* DP* 4-aminopiperidine and their use as a medicine
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Jul 25, 2018
Oct 6, 2021 
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
Jun 17, 2027 
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, 2026U-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. 7858789 DS* DP* Derivatives of 4-aminopiperidine and their use as a medicament
Claim Types: Compound
Pat. Sub. Date(s): 002: Jul 25, 2018
Dec 13, 2020 
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. 8110574 DS* DP* Derivatives of 4-aminopiperidine and their use as a medicament
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Jul 25, 2018
Dec 13, 2020 
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, 2024U-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, 2024U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9296694 DS* DP* Azacyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 002: Jul 25, 2018
Mar 6, 2021 
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, 2024U-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, 2022U-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, 2024U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 29, 2021 

ACADIA PHARMS INC
NUPLAZID (CAPSULE) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: atypical antipsychotic
NDA Applicant: ACADIA PHARMS INC      NDA No.: 210793  Prod. No.: 001 RX (EQ 34MG BASE)
PatentsExpirationPatented Use
Pat. No. 6756393 DS* DP* Azacyclic compounds
Claim Types: Compound; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 25, 2018
Mar 6, 2021 
Pat. No. 6815458 DS* DP* Azacyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Mar 6, 2021U-1843: Treatment of psychosis
Pat. No. 7115634 DS* DP* 4-aminopiperidine and their use as a medicine
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 25, 2018
Oct 6, 2021 
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
Jun 17, 2027 
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, 2026U-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. 7858789 DS* DP* Derivatives of 4-aminopiperidine and their use as a medicament
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 25, 2018
Dec 13, 2020 
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. 8110574 DS* DP* Derivatives of 4-aminopiperidine and their use as a medicament
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 25, 2018
Dec 13, 2020 
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, 2024U-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, 2024U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9296694 DS* DP* Azacyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 25, 2018
Mar 6, 2021 
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 
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, 2022U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 29, 2021 

ACCORD HLTHCARE
DALFAMPRIDINE (TABLET, EXTENDED RELEASE) (ORAL) DALFAMPRIDINE [GENERIC AB]
Drug Classes: potassium channel blocker
NDA Applicant: ACCORD HLTHCARE      NDA No.: 206863  Prod. No.: 001 RX (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeMar 9, 2019 

ACCORD HLTHCARE
DAPTOMYCIN (POWDER) (IV (INFUSION)) DAPTOMYCIN [GENERIC AP]
Drug Classes: lipopeptide antibacterial
NDA Applicant: ACCORD HLTHCARE      NDA No.: 212667  Prod. No.: 001 RX (350MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyJan 12, 2020 

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)
PatentsExpirationPatented 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, 2030U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2030U-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, 2027U-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, 2027U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productNov 2, 2021 

ACLARIS
ESKATA (SOLUTION) (TOPICAL) HYDROGEN PEROXIDE
Drug Classes: aldehyde dehydrogenase inhibitor; isocitrate dehydrogenase-2 inhibitor
NDA Applicant: ACLARIS      NDA No.: 209305  Prod. No.: 001 RX (40%)
PatentsExpirationPatented Use
Pat. No. 7381427 Seborrheic keratosis treatment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 3, 2018
Jun 8, 2022U-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, 2035U-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, 2035U-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, 2035U-2205: Treatment of seborrheic keratoses that are raised
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 14, 2020 

ACLARIS
RHOFADE (CREAM) (TOPICAL) OXYMETAZOLINE HYDROCHLORIDE
Drug Classes: vasoconstrictor
NDA Applicant: ACLARIS      NDA No.: 208552  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 7812049 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 9, 2017
May 2, 2028U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 8420688 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 9, 2017
Aug 2, 2024U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 8815929 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 12, 2018
Jan 22, 2024U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 8883838 DP* Pharmaceutical cream compositions and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 9, 2017
Dec 1, 2031 
Pat. No. 9974773 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 22, 2018
Jun 11, 2035U-2306: Once daily topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 10335391 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2019
Jun 11, 2035U-2567: Once daily topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream, where the patient experiences no rebound or worsening of facial erythema post-treatment
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJan 18, 2020 

ACORDA
AMPYRA (TABLET, EXTENDED RELEASE) (ORAL) DALFAMPRIDINE [GENERIC AB]
Drug Classes: potassium channel blocker
NDA Applicant: ACORDA      NDA No.: 022250  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 8007826 Sustained release aminopyridine composition
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 28, 2011
May 26, 2027U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8354437 Method of using sustained release aminopyridine compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 13, 2013
Dec 22, 2026U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8440703 Methods of using sustained release aminopyridine compositions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 12, 2013
Apr 8, 2025U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 8663685 Sustained release aminopyridine composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 2, 2014
Jan 18, 2025U-1030: Improvement of walking in patients with multiple sclerosis (MS)
Pat. No. 9918973 Sustained release aminopyridine composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2018
Dec 13, 2024U-1030: Improvement of walking in patients with multiple sclerosis (MS)

ACORDA
INBRIJA (POWDER) (INHALATION) LEVODOPA
Drug Classes: aromatic amino acid
NDA Applicant: ACORDA      NDA No.: 209184  Prod. No.: 001 RX (42MG)
PatentsExpirationPatented 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, 2029U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 6514482 DP* Pulmonary delivery in treating disorders of the central nervous system
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Sep 19, 2020U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 6613308 Pulmonary delivery in treating disorders of the central nervous system
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2019
Sep 19, 2020U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 6858199 High efficient delivery of a large therapeutic mass aerosol
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 4, 2021U-2485: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles through a single breath activated step
Pat. No. 6921528 Highly efficient delivery of a large therapeutic mass aerosol
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Jun 19, 2020U-2485: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles through a single breath activated step
Pat. No. 6979437 Pulmonary delivery in treating disorders of the central nervous system
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 18, 2019
Sep 19, 2020U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 7146978 Inhalation device and method
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Apr 16, 2021U-2486: Intermittent treatment of off episodes in patients with Parkinson's Disease with a powder inhaler
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. 7556798 Highly efficient delivery of a large therapeutic mass aerosol
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 4, 2021U-2485: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles through a single breath activated step
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, 2023U-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, 2023U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 8628754 Highly efficient delivery of a large therapeutic mass aerosol
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Jun 19, 2020U-2485: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles through a single breath activated step
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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 21, 2021 

ACROTECH
BELEODAQ (POWDER) (INTRAVENOUS) BELINOSTAT
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: ACROTECH      NDA No.: 206256  Prod. No.: 001 RX (500MG/VIAL)
PatentsExpirationPatented 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
Sep 27, 2021U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 3, 2019 
Exclusivity Code: ODE - Orphan drug exclusivityJul 3, 2021ODE-68: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

ACROTECH
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: ACROTECH      NDA No.: 207155  Prod. No.: 001 RX (EQ 50MG BASE/VIAL)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMar 10, 2023ODE-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))
PatentsExpirationPatented 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, 2022U-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, 2025U-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, 2025U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

ACROTECH
FUSILEV (POWDER; SOLUTION) (INTRAVENOUS) LEVOLEUCOVORIN CALCIUM [GENERIC AP]
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)**)
PatentsExpirationPatented 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 

ACROTECH
MARQIBO KIT (INJECTABLE, LIPOSOMAL) (INTRAVENOUS) VINCRISTINE SULFATE
Drug Classes: vinca alkaloid
NDA Applicant: ACROTECH      NDA No.: 202497  Prod. No.: 001 RX (5MG/5ML (1MG/ML))
PatentsExpirationPatented Use
Pat. No. 6723338 Compositions and methods for treating lymphoma
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2012
Mar 31, 2020U-1271: Treatment of adult patients with Philadelphia chromosome-negative(ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies
Pat. No. 7247316 DP* Compositions and methods for treating lymphoma
Claim Types: Kit
Pat. Sub. Date(s): 001: Sep 6, 2012
Sep 25, 2020 
Pat. No. 7887836 Compositions and methods for treating lymphoma
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2012
Mar 31, 2020U-1271: Treatment of adult patients with Philadelphia chromosome-negative(ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityAug 9, 2019ODE-28: Treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies

ACTAVIS ELIZABETH
DEFERASIROX (TABLET, FOR SUSPENSION) (ORAL) DEFERASIROX [GENERIC AB]
Drug Classes: iron chelator
NDA Applicant: ACTAVIS ELIZABETH      NDA No.: 203560  Prod. No.: 001 RX (125MG); 002 RX (250MG); 003 RX (500MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeApr 5, 2019 

ACTAVIS LABS UT INC
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE (GEL) (TOPICAL) BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE [GENERIC AB]
Drug Classes: lincosamide antibacterial
NDA Applicant: ACTAVIS LABS UT INC      NDA No.: 205128  Prod. No.: 001 RX (2.5%;EQ 1.2% BASE)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeAug 18, 2019 

ACTELION PHARMS
TRACLEER (TABLET, FOR SUSPENSION) (ORAL) BOSENTAN
Drug Classes: endothelin receptor antagonist
NDA Applicant: ACTELION PHARMS      NDA No.: 209279  Prod. No.: 001 RX (32MG)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productSep 5, 2020 
Exclusivity Code: ODE - Orphan drug exclusivitySep 5, 2024ODE-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 PHARMS LTD
OPSUMIT (TABLET) (ORAL) MACITENTAN
Drug Classes: endothelin receptor antagonist
NDA Applicant: ACTELION PHARMS LTD      NDA No.: 204410  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented 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, 2029U-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, 2028U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, 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, 2027U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityOct 18, 2020ODE-54: Tx of PAH to delay disease progression. disease progression included: death, initiation of IV or SC prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment).

ACTELION PHARMS LTD
TRACLEER (TABLET) (ORAL) BOSENTAN [GENERIC AB]
Drug Classes: endothelin receptor antagonist
NDA Applicant: ACTELION PHARMS LTD      NDA No.: 021290  Prod. No.: 001 RX (62.5MG); 002 RX (125MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationSep 5, 2020 

ACTELION PHARMS LTD
UPTRAVI (TABLET) (ORAL) SELEXIPAG
Drug Classes: prostacyclin receptor agonist
NDA Applicant: ACTELION PHARMS LTD      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)
PatentsExpirationPatented 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
Apr 4, 2023U-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, 2029U-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, 2030U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 21, 2020 
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2022ODE-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 PHARMS LTD
VELETRI (INJECTABLE) (INJECTION) EPOPROSTENOL SODIUM [Has competitive generic]
Drug Classes: prostacycline vasodilator
NDA Applicant: ACTELION PHARMS LTD      NDA No.: 022260  Prod. No.: 001 RX (EQ 1.5MG BASE/VIAL); 002 RX (EQ 0.5MG BASE/VIAL)
PatentsExpirationPatented 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: 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)
PatentsExpirationPatented 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, 2028U-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, 2030U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2034U-2459: Treatment of dyskinesia and decreasing off time in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 24, 2020I-769: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Exclusivity Code: ODE - Orphan drug exclusivityAug 24, 2024ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications

ADAPT
NARCAN (SPRAY, METERED) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: ADAPT      NDA No.: 208411  Prod. No.: 001 RX (4MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 9211253 DP* Nasal drug products and methods of their use
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 16, 2015
Mar 16, 2035 
Pat. No. 9468747 DP* Nasal drug products and methods of their use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 18, 2016
Mar 16, 2035U-1903: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Pat. No. 9561177 DP* Nasal drug products and methods of their use
Claim Types: Method of use; Method of administration; Formulation
Pat. Sub. Date(s): 001: Feb 7, 2017
Mar 16, 2035U-1903: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Pat. No. 9629965 DP* Nasal drug products and methods of their use
Claim Types: Formulation; Method of use; Device
Pat. Sub. Date(s): 001: Apr 27, 2017
Mar 16, 2035U-1903: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Pat. No. 9775838 Nasal drug products and methods of their use
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2017
Mar 16, 2035U-1903: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Pat. No. 10085937 Nasal drug products and methods of their use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 3, 2018
Mar 16, 2035U-1903: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

ADAPT
NARCAN (SPRAY, METERED) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: ADAPT      NDA No.: 208411  Prod. No.: 002 DISC (2MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 9480644 DP* Nasal drug products and methods of their use
Claim Types: Device; Formulation; Method of use
Pat. Sub. Date(s): 002: Jan 30, 2017
Mar 16, 2035U-1903: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Pat. No. 9707226 DP* Nasal drug products and methods of their use
Claim Types: Method of use; Method of administration; Formulation
Pat. Sub. Date(s): 002: Jul 18, 2017
Mar 16, 2035U-1903: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

ADDMEDICA SAS
SIKLOS (TABLET) (ORAL) HYDROXYUREA
Drug Classes: antimetabolite
NDA Applicant: ADDMEDICA SAS      NDA No.: 208843  Prod. No.: 001 RX (100MG); 002 RX (1GM)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 21, 2020 
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2024ODE-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: dihydropyridine calcium channel blocker; 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)
PatentsExpirationPatented 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, 2023U-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, 2029U-3: Treatment of hypertension

ADIENNE SA
TEPADINA (POWDER) (INTRAVENOUS) THIOTEPA
Drug Classes: alkylating drug
NDA Applicant: ADIENNE SA      NDA No.: 208264  Prod. No.: 001 RX (15MG/VIAL); 002 RX (100MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 26, 2020I-747: For reducing the risk of graft rejection when used with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation for pediatric patients with class 3 beta-thalassemia
Exclusivity Code: ODE - Orphan drug exclusivityJan 26, 2024ODE-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

AEGERION
JUXTAPID (CAPSULE) (ORAL) LOMITAPIDE MESYLATE
Drug Classes: microsomal triglyceride transfer protein inhibitor
NDA Applicant: AEGERION      NDA No.: 203858  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE); 004 RX (EQ 30MG BASE); 005 RX (EQ 40MG BASE); 006 RX (EQ 60MG BASE)
PatentsExpirationPatented Use
Pat. No. 5712279 DS* DP* [Extended 5 years]
Inhibitors of microsomal triglyceride transfer protein and method
Claim Types: Compound; Method of use
Pat. Sub. Date(s): 001: Jan 14, 2013; 002: Jan 14, 2013; 003: Jan 14, 2013; 004: May 29, 2015; 005: May 29, 2015; 006: May 29, 2015
Feb 21, 2020U-1317: Treatment of hypercholesterolemia, hyperlipidemia and hyperlipoproteinemia in patients with homozygous familial hypercholesterolemia
Pat. No. 6492365 Microsomal triglyceride transfer protein
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2013; 002: None; 003: None; 004: May 29, 2015; 005: May 29, 2015; 006: May 29, 2015
Dec 10, 2019U-1318: Treatment of hypercholesterolemia by decreasing the amount or activity of microsomal triglyceride transfer protein in patients with homozygous familial hypercholesterolemia
Pat. No. 7932268 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2013; 002: None; 003: None; 004: May 29, 2015; 005: May 29, 2015; 006: May 29, 2015
Aug 19, 2027U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 8618135 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 22, 2014; 002: Jan 22, 2014; 003: Jan 22, 2014; 004: May 29, 2015; 005: May 29, 2015; 006: May 29, 2015
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 9265758 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 23, 2016
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 9364470 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jun 20, 2016
Mar 7, 2025U-1851: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 9433617 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 8, 2016
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 9861622 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Feb 5, 2018
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
Pat. No. 10016404 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Claim Types: Dosaage regimen
Pat. Sub. Date(s): All strengths: Aug 2, 2018
Mar 7, 2025U-1316: A dosing regimen for the treatment of hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia using at least three step-wise increasing doses
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 21, 2019ODE-36: Adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce LDL-C, TC, apolipoprotein b, & non-HDL-C in patients with homozygous familial hypercholesterolemia

AERIE PHARMS INC
RHOPRESSA (SOLUTION/DROPS) (OPHTHALMIC) NETARSUDIL DIMESYLATE
Drug Classes: Rho kinase inhibitor
NDA Applicant: AERIE PHARMS INC      NDA No.: 208254  Prod. No.: 001 RX (EQ 0.02% BASE)
PatentsExpirationPatented 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, 2030U-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, 2026U-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, 2026U-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, 2034U-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, 2030U-1524: Reduction of elevated intraocular pressure
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 18, 2022 

AERIE PHARMS INC
ROCKLATAN (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST; NETARSUDIL DIMESYLATE
Drug Classes: prostaglandin analog; Rho kinase inhibitor
NDA Applicant: AERIE PHARMS INC      NDA No.: 208259  Prod. No.: 001 RX (0.005%;EQ 0.02% BASE)
PatentsExpirationPatented 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, 2030U-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, 2026U-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, 2026U-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, 2034U-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, 2034U-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, 2030U-1524: Reduction of elevated intraocular pressure
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationMar 12, 2022 
Exclusivity Code: NCE - New chemical entityDec 18, 2022 

AGIOS PHARMS INC
TIBSOVO (TABLET) (ORAL) IVOSIDENIB
NDA Applicant: AGIOS PHARMS INC      NDA No.: 211192  Prod. No.: 001 RX (250MG)
PatentsExpirationPatented Use
Pat. No. 9474779 DS* DP* Therapeutically active compositions and their methods of use
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 13, 2018
Aug 19, 2033U-2350: A method of treating a cancer characterized by an IDH1 mutation where the cancer is acute myelogenous leukemia (AML)
U-2533: A method of treating a cancer characterized by an IDH1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (AML)
U-2534: A method of treating a cancer characterized by an IDH1 mutation where the cancer is newly diagnosed acute myeloid leukemia (AML)
Pat. No. 9850277 DS* DP* Therapeutically active compositions and their methods of use
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 13, 2018
Jan 18, 2033U-2350: A method of treating a cancer characterized by an IDH1 mutation where the cancer is acute myelogenous leukemia (AML)
U-2533: A method of treating a cancer characterized by an IDH1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (AML)
U-2534: A method of treating a cancer characterized by an IDH1 mutation where the cancer is newly diagnosed acute myeloid leukemia (AML)
Pat. No. 9968595 DP* Pharmaceutical compositions of therapeutically active compounds
Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Method of use
Pat. Sub. Date(s): 001: Aug 13, 2018
Mar 13, 2035U-2351: Treatment of acute myeloid leukemia (AML) with an IDH1 mutation
U-2533: A method of treating a cancer characterized by an IDH1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (AML)
U-2534: A method of treating a cancer characterized by an IDH1 mutation where the cancer is newly diagnosed acute myeloid leukemia (AML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 20, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityJul 20, 2025ODE-203: Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test
Exclusivity Code: ODE - Orphan drug exclusivityMay 2, 2026ODE-242: Tx of newly-diagnosed acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test in adult pts who are >=75 yrs old or who have comorbidities that preclude use of intensive induction chemotherapy

AKARX INC
DOPTELET (TABLET) (ORAL) AVATROMBOPAG MALEATE
NDA Applicant: AKARX INC      NDA No.: 210238  Prod. No.: 001 RX (EQ 20MG BASE)
PatentsExpirationPatented 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, 2023U-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, 2023U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 26, 2022I-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 entityMay 21, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityJun 26, 2026ODE-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
NDA Applicant: AKCEA THERAPS      NDA No.: 211172  Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))
PatentsExpirationPatented 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, 2031U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityOct 5, 2025ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

AKORN
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic; antiarrhythmic
NDA Applicant: AKORN      NDA No.: 022221  Prod. No.: 001 RX (3.5%)
PatentsExpirationPatented Use
Pat. No. 8759401 DP* Aqueous gel formulation and method for inducing topical anesthesia
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 30, 2014
Jul 24, 2026U-1523: Method of inducing topical anesthesia in the eye

ALCON PHARMS LTD
NAVSTEL (SOLUTION) (IRRIGATION) CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
NDA Applicant: ALCON PHARMS LTD      NDA No.: 022193  Prod. No.: 001 DISC (0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML)
PatentsExpirationPatented Use
Pat. No. 7084130 DP* Intraocular irrigating solution having improved flow characteristics
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Nov 29, 2021U-891: Use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye

ALIMERA SCIENCES INC
ILUVIEN (IMPLANT) (INTRAVITREAL) FLUOCINOLONE ACETONIDE
Drug Classes: corticosteroid
NDA Applicant: ALIMERA SCIENCES INC      NDA No.: 201923  Prod. No.: 001 RX (0.19MG)
PatentsExpirationPatented Use
Pat. No. 6217895 DP* Method for treating and/or preventing retinal diseases with sustained release corticosteroids
Claim Types: Method of use; Device
Pat. Sub. Date(s): 001: Oct 23, 2014
Mar 22, 2019U-1597: Treatment of diabetic macular edema
Pat. No. 6375972 DP* Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Oct 23, 2014
Apr 26, 2020U-1597: Treatment of diabetic macular edema
Pat. No. 6548078 DP* Method for treating and/or preventing retinal diseases with sustained release corticosteroids
Claim Types: Method of use; Device
Pat. Sub. Date(s): 001: Oct 23, 2014
Mar 22, 2019U-1597: Treatment of diabetic macular edema
Pat. No. 8252307 DP* Method for treating and/or preventing retinal diseases with sustained release corticosteroids
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 23, 2014
Jun 27, 2019 
Pat. No. 8871241 DP* Injectable sustained release delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 12, 2014
Aug 12, 2027 

ALKERMES
VIVITROL (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) NALTREXONE
Drug Classes: opioid antagonist
NDA Applicant: ALKERMES      NDA No.: 021897  Prod. No.: 001 RX (380MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6264987 DP* Method for preparing microparticles having a selected polymer molecular weight
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
May 19, 2020 
Pat. No. 6331317 DP* Apparatus and method for preparing microparticles
Claim Types: Device; Product-by-process; Process
Pat. Sub. Date(s): 001: None
Nov 12, 2019 
Pat. No. 6379704 DP* Method for preparing microparticles having a selected polymer molecular weight
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
May 19, 2020 
Pat. No. 6395304 DP* Apparatus and method for preparing microparticles
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: None
Nov 12, 2019 
Pat. No. 6495164 DP* Preparation of injectable suspensions having improved injectability
Claim Types: Formulation; Process; Method of use; Product-by-process
Pat. Sub. Date(s): 001: None
May 25, 2020 
Pat. No. 6495166 DP* Apparatus and method for preparing microparticles using in-line solvent extraction
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: None
Nov 12, 2019 
Pat. No. 6534092 DP* Method for preparing microparticles having a selected polymer molecular weight
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
May 19, 2020 
Pat. No. 6537586 DP* Apparatus and method for preparing microparticles
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Nov 12, 2019 
Pat. No. 6667061 DP* Preparation of injectable suspensions having improved injectability
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 25, 2020 
Pat. No. 6713090 DP* Apparatus and method for preparing microparticles
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Nov 12, 2019 
Pat. No. 6939033 DP* Method and apparatus for preparing microparticles using in-line solvent extraction
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Nov 12, 2019 
Pat. No. 7799345 DP* Preparation of injectable suspensions having improved injectability
Claim Types: Composition
Pat. Sub. Date(s): 001: Oct 28, 2010
May 25, 2020 
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, 2029U-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: 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))
PatentsExpirationPatented 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, 2030U-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, 2032U-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, 2033U-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, 2035U-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, 2030U-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
Nov 7, 2032U-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, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2020 

ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 207533  Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML)); 003 RX (882MG/3.2ML (275.63MG/ML))
PatentsExpirationPatented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): All strengths: 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): All strengths: Oct 14, 2015
Jun 24, 2030U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2015
Nov 7, 2032U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 9, 2015
Oct 24, 2033U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Oct 5, 2016
Mar 19, 2035U-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): All strengths: 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): All strengths: Nov 20, 2018
Jun 24, 2030U-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
Nov 7, 2032U-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, 2035U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2020 

ALKERMES INC
ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.: 209830  Prod. No.: 001 RX (675MG/2.4ML)
PatentsExpirationPatented 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, 2030U-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, 2030U-543: Treatment of schizophrenia
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 5, 2020 

ALLERGAN
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: ALLERGAN      NDA No.: 021528  Prod. No.: 001 RX (0.4%)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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, 2024U-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, 2024U-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, 2024U-1800: A method of treating ocular pain and/or enhancing ocular comfort

ALLERGAN
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: cyclooxygenase inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: ALLERGAN      NDA No.: 022427  Prod. No.: 001 RX (0.45%)
PatentsExpirationPatented 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
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021262  Prod. No.: 001 RX (0.15%)
PatentsExpirationPatented 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 *PEDU-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: alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021770  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented 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 *PEDU-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 
Pat. No. 10307368 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 24, 2019
Jul 10, 2021 

ALLERGAN
COMBIGAN (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Drug Classes: alpha adrenergic agonist; beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN      NDA No.: 021398  Prod. No.: 001 RX (0.2%;EQ 0.5% BASE)
PatentsExpirationPatented 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, 2022U-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, 2022U-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. 7323463 DP* DLR* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Jan 19, 2023 
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, 2022U-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, 2022U-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, 2022U-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, 2022U-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, 2022U-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, 2022U-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, 2022U-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, 2022U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid

ALLERGAN
LASTACAFT (SOLUTION/DROPS) (OPHTHALMIC) ALCAFTADINE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: ALLERGAN      NDA No.: 022134  Prod. No.: 001 RX (0.25%)
PatentsExpirationPatented Use
Pat. No. 8664215 Ocular allergy treatments with alcaftadine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2014
Dec 23, 2027U-1493: Method for preventing itching associated with allergic conjunctivitis

ALLERGAN
LATISSE (SOLUTION/DROPS) (TOPICAL) BIMATOPROST [GENERIC AT]
Drug Classes: prostaglandin analog
NDA Applicant: ALLERGAN      NDA No.: 022369  Prod. No.: 001 RX (0.03%)
PatentsExpirationPatented 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, 2023U-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, 2024U-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, 2023U-1277: Method of increasing eyelash growth including length, thickness, darkness and/or number of eyelashes by administering bimatoprost to an eyelid margin
Pat. No. 8541466 Compositions and methods for treating hair loss using non-naturally occurring prostaglandins
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 27, 2015
Jan 31, 2021U-1217: Method of increasing hair growth
Pat. No. 8632760 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2014
Jan 15, 2023U-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, 2023U-1487: Method of increasing eyelash growth
Pat. No. 8906962 Compositions and methods for treating hair loss using non-naturally occurring prostaglandins
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2014
Jan 31, 2021U-1217: Method of increasing hair growth
Pat. No. 8986715 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 1, 2015
Jan 15, 2023U-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, 2023U-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, 2023U-1799: Method of increasing growth of hair including eyelashes
Pat. No. 9579270 Compositions and methods for treating hair loss using non-naturally occurring prostaglandins
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2017
Jan 31, 2021U-1975: Method of increasing eyelash growth with bimatoprost

ALLERGAN
LUMIGAN (SOLUTION/DROPS) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
NDA Applicant: ALLERGAN      NDA No.: 022184  Prod. No.: 001 RX (0.01%)
PatentsExpirationPatented 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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-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, 2025U-1814: Method of treating glaucoma or elevated intraocular pressure

ALLERGAN
OZURDEX (IMPLANT) (INTRAVITREAL) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: ALLERGAN      NDA No.: 022315  Prod. No.: 001 RX (0.7MG)
PatentsExpirationPatented Use
Pat. No. 6726918 DP* Methods for treating inflammation-mediated conditions of the eye
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Oct 20, 2020U-1204: Treatment of uveitis
U-1205: Treatment of macular edema
Pat. No. 6899717 Methods and apparatus for delivery of ocular implants
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Nov 1, 2023U-1206: Delivering an ocular implant as described in the dosage and administration section of the approved labeling of OZURDEX
Pat. No. 7033605 DP* Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Oct 20, 2020 
Pat. No. 7767223 DP* Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 28, 2021 
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, 2023U-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. 8043628 Methods for reducing edema
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Oct 20, 2020U-1205: Treatment of macular edema
Pat. No. 8063031 DP* Implants and methods for treating inflammation-mediated conditions of the eye
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 23, 2011
Oct 20, 2020 
Pat. No. 8088407 Method for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Oct 20, 2020U-1205: Treatment of macular edema
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, 2023U-1204: Treatment of uveitis
U-1205: Treatment of macular edema
Pat. No. 9012437 Implants and methods for treating inflammation-mediated conditions of the eye
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 19, 2015
Oct 20, 2020U-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. 9283178 Methods for treating edema in the eye and intraocular implants for use therefor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 12, 2016
Oct 20, 2020U-1205: Treatment of macular edema
Pat. No. 9592242 Methods for treating edema in the eye and intraocular implants for use therefor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 13, 2017
Oct 20, 2020U-1989: Intravitreal treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
U-1990: Intravitreal treatment of diabetic macular edema
Pat. No. 9775849 Implants and methods for treating inflammation-mediated conditions of the eye
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 2, 2017
Oct 20, 2020U-1989: Intravitreal treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
U-1990: Intravitreal treatment of diabetic macular edema
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 

ALLERGAN
RESTASIS (EMULSION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ALLERGAN      NDA No.: 050790  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 8629111 DP* Methods of providing therapeutic effects using cyclosporin components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 14, 2014
Aug 27, 2024 
Pat. No. 8633162 Methods of providing therapeutic effects using cyclosporin components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2014
Aug 27, 2024U-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): 001: Feb 4, 2014
Aug 27, 2024 
Pat. No. 8648048 Methods of providing therapeutic effects using cyclosporin components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 11, 2014
Aug 27, 2024U-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): 001: Apr 1, 2014
Aug 27, 2024 
Pat. No. 9248191 Methods of providing therapeutic effects using cyclosporin components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 2, 2016
Aug 27, 2024U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye).

ALLERGAN
RESTASIS MULTIDOSE (EMULSION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: ALLERGAN      NDA No.: 050790  Prod. No.: 002 RX (0.05%)
PatentsExpirationPatented 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, 2024U-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, 2024U-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, 2024U-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
ZYMAR (SOLUTION/DROPS) (OPHTHALMIC) GATIFLOXACIN
Drug Classes: quinolone antimicrobial
NDA Applicant: ALLERGAN      NDA No.: 021493  Prod. No.: 001 RX (0.3%)
PatentsExpirationPatented Use
Pat. No. 6333045 DP* DLR* Aqueous liquid pharmaceutical composition comprised of gatifloxacin
Claim Types: Formulation; Method of use Process
Pat. Sub. Date(s): 001: None
Feb 20, 2020 *PED 

ALLERGAN HOLDINGS
VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: mu-opioid receptor agonist
NDA Applicant: ALLERGAN HOLDINGS      NDA No.: 206940  Prod. No.: 001 RX (75MG); 002 RX (100MG)
PatentsExpirationPatented Use
Pat. No. 7741356 DS* DP* Compounds as opioid receptor modulators
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Jun 26, 2015
Mar 25, 2028 
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, 2025U-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, 2028U-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
Comments: Method of use
Mar 14, 2025U-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, 2028U-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, 2025U-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, 2028U-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, 2028U-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, 2025U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 27, 2020 

ALLERGAN SALES LLC
AVYCAZ (POWDER) (IV (INFUSION)) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor; cephalosporin antibacterial
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
PatentsExpirationPatented 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
Feb 24, 2022U-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. 8178554 DS* DP* Heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 17, 2015
Jul 24, 2021U-2245: A method of treating a bacterial infection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering an effective amount of avibactam sodium
U-2509: A method of treating a bacterial infection in complicated intra-abdominal infection (CIAI) and complicated urinary tract infection (CUTI), including pyelonephritis, patients comprising administering an effective amount of avibactam sodium
U-282: Method of treating bacterial infections
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 

ALLERGAN SALES LLC
BYSTOLIC (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE
Drug Classes: beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 021742  Prod. No.: 002 RX (EQ 2.5MG BASE); 003 RX (EQ 5MG BASE); 004 RX (EQ 10MG BASE); 005 RX (EQ 20MG BASE)
PatentsExpirationPatented Use
Pat. No. 6545040 DP* [Extended 618 days (1.7 years)]
Method of lowering the blood pressure
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Dec 17, 2021U-3: Treatment of hypertension

ALLERGAN SALES LLC
BYVALSON (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Drug Classes: beta-adrenergic receptor inhibitor; angiotensin II receptor blocker
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 206302  Prod. No.: 001 RX (EQ 5MG BASE;80MG)
PatentsExpirationPatented 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, 2027U-185: Method of treating hypertension
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationJun 3, 2019 

ALLERGAN SALES LLC
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE
Drug Classes: aminosalicylate
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 021252  Prod. No.: 001 DISC (500MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousSep 2, 2019M-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling

ALLERGAN SALES LLC
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 021252  Prod. No.: 002 RX (1GM)
PatentsExpirationPatented 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
Pat. Sub. Date(s): 002: May 24, 2013
Comments: Method of use
Jun 6, 2028 

ALLERGAN SALES LLC
DALVANCE (POWDER) (INTRAVENOUS) DALBAVANCIN HYDROCHLORIDE
Drug Classes: lipoglycopeptide antibacterial
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 021883  Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
PatentsExpirationPatented 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, 2023U-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, 2023U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin.
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleJan 20, 2019D-154: Addition of a 1500mg-single-dose regimen for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSI)
Exclusivity Code: GAIN - Generating Antibiotic Incentives NowMay 23, 2024 
Exclusivity Code: NCE - New chemical entityMay 23, 2019 

ALLERGAN SALES LLC
FETZIMA (CAPSULE, EXTENDED RELEASE) (ORAL) LEVOMILNACIPRAN HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALLERGAN SALES LLC      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)
PatentsExpirationPatented 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
Jun 3, 2023U-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, 2031U-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 

ALLERGAN SALES LLC
GELNIQUE (GEL) (TRANSDERMAL) OXYBUTYNIN CHLORIDE [GENERIC AB]
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 022204  Prod. No.: 001 RX (10% (100MG/PACKET))
PatentsExpirationPatented Use
Pat. No. 7029694 DP* Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7179483 Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 8241662 Unoccluded topical oxybutynin gel composition and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2012
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
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, 2031U-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, 2029U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin
Pat. No. 10272061 Compositions and methods for unoccluded transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2019
Apr 26, 2020U-2525: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency or urge incontinence

ALLERGAN SALES LLC
GELNIQUE 3% (GEL, METERED) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 202513  Prod. No.: 001 DISC (3%)
PatentsExpirationPatented Use
Pat. No. 7029694 DP* Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Apr 27, 2012
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7179483 Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 27, 2012
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7198801 DP* Formulations for transdermal or transmucosal application
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 27, 2012
Jun 25, 2022 
Pat. No. 8241662 Unoccluded topical oxybutynin gel composition and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 23, 2012
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence

ALLERGAN SALES LLC
LEXAPRO (TABLET) (ORAL) ESCITALOPRAM OXALATE [GENERIC AB]
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 021323  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE)
PatentsExpirationPatented 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 SALES LLC
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 202811  Prod. No.: 001 RX (145MCG)
PatentsExpirationPatented 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, 2026U-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, 2024U-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, 2031U-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, 2033U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.

ALLERGAN SALES LLC
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 202811  Prod. No.: 002 RX (290MCG)
PatentsExpirationPatented 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, 2026U-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, 2024U-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, 2031U-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, 2033U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.

ALLERGAN SALES LLC
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 202811  Prod. No.: 003 RX (72MCG)
PatentsExpirationPatented 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, 2026U-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, 2024U-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, 2031U-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, 2033U-1516: Method of treating chronic idiopathic constipation in adult patients.
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthJan 25, 2020 

ALLERGAN SALES LLC
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: cholinesterase inhibitor; N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 206439  Prod. No.: 001 RX (10MG;14MG); 002 RX (10MG;28MG); 003 RX (10MG;7MG); 004 RX (10MG;21MG)
PatentsExpirationPatented 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 *PEDU-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, 2029U-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 *PEDU-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 *PEDU-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, 2025U-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 *PEDU-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, 2025U-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 SALES LLC
OXYTROL (FILM, EXTENDED RELEASE) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 021351  Prod. No.: 002 RX (3.9MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6743441 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Device
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7081249 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7081250 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7081251 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7081252 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Pat. No. 7179483 DS* DP* Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Apr 26, 2020U-318: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence

ALLERGAN SALES LLC
OXYTROL FOR WOMEN (FILM, EXTENDED RELEASE) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 202211  Prod. No.: 001 OTC (3.9MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6743441 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Device
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7081249 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7081250 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7081251 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7081252 DP* Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder
Pat. No. 7179483 Compositions and methods for transdermal oxybutynin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 26, 2020U-1329: Treatment of patients with an overactive bladder

ALLERGAN SALES LLC
SAVELLA (TABLET) (ORAL) MILNACIPRAN HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 022256  Prod. No.: 001 RX (12.5MG); 002 RX (25MG); 003 RX (50MG); 004 RX (100MG)
PatentsExpirationPatented 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, 2023U-882: Management of fibromyalgia (FM)
Pat. No. 6992110 Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Nov 5, 2021U-882: Management of fibromyalgia (FM)
Pat. No. 7888342 Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 15, 2011; 002: None; 003: None; 004: None
Nov 5, 2021U-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, 2029U-819: Management of fibromyalgia

ALLERGAN SALES LLC
TEFLARO (POWDER) (INTRAVENOUS) CEFTAROLINE FOSAMIL
Drug Classes: cephalosporin antibacterial
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 200327  Prod. No.: 001 RX (400MG/VIAL); 002 RX (600MG/VIAL)
PatentsExpirationPatented 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, 2022U-1676: Methods for treating bacterial infections
Pat. No. 6906055 DS* DP* Phosphonocephem compound
Claim Types: Compound; Composition; Process; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Dec 15, 2021 
Pat. No. 7419973 DP* Phosphonocephem compound
Claim Types: Composition
Pat. Sub. Date(s): All strengths: None
Dec 15, 2021 
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, 2031U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 27, 2019 

ALLERGAN SALES LLC
TRELSTAR (INJECTABLE) (INTRAMUSCULAR) TRIPTORELIN PAMOATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 022437  Prod. No.: 001 RX (EQ 22.5MG BASE/VIAL)
PatentsExpirationPatented Use
Pat. No. 10166181 DP* Slow release pharmaceutical composition made of microgranules
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 25, 2019
Feb 10, 2029 

ALLERGAN SALES LLC
VIIBRYD (TABLET) (ORAL) VILAZODONE HYDROCHLORIDE
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 022567  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG)
PatentsExpirationPatented Use
Pat. No. 5532241 DS* DP* [Extended 5 years]
Piperidines and piperazines
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Jan 25, 2011
Sep 29, 2019 
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
Jun 5, 2022U-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
Jun 5, 2022U-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
Jun 5, 2022U-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
Jun 5, 2022 

ALLERGAN SALES LLC
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 204370  Prod. No.: 001 RX (EQ 1.5MG BASE)
PatentsExpirationPatented 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, 2029U-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
Mar 27, 2027U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 24, 2022I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression)
Exclusivity Code: M - MiscellaneousNov 9, 2020M-213: Information added to the labeling to include the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in patients with schizophrenia
Exclusivity Code: NCE - New chemical entitySep 17, 2020 

ALLERGAN SALES LLC
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 204370  Prod. No.: 002 RX (EQ 3MG BASE)
PatentsExpirationPatented 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
Mar 27, 2027U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 24, 2022I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression)
Exclusivity Code: M - MiscellaneousNov 9, 2020M-213: Information added to the labeling to include the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in patients with schizophrenia
Exclusivity Code: NCE - New chemical entitySep 17, 2020 

ALLERGAN SALES LLC
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN SALES LLC      NDA No.: 204370  Prod. No.: 003 RX (EQ 4.5MG BASE); 004 RX (EQ 6MG BASE)
PatentsExpirationPatented 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
Mar 27, 2027U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 24, 2022I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression)
Exclusivity Code: M - MiscellaneousNov 9, 2020M-213: Information added to the labeling to include the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in patients with schizophrenia
Exclusivity Code: NCE - New chemical entitySep 17, 2020 

ALMIRALL
ACZONE (GEL) (TOPICAL) DAPSONE [GENERIC AB]
Drug Classes: sulfone
NDA Applicant: ALMIRALL      NDA No.: 207154  Prod. No.: 001 RX (7.5%)
PatentsExpirationPatented 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, 2033U-1033: Topical treatment of acne vulgaris
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthFeb 24, 2019 

ALMIRALL
ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: pleuromutilin antibacterial
NDA Applicant: ALMIRALL      NDA No.: 022055  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. RE43390 DS* DP* Pleuromutilin derivatives as antimicrobials
Claim Types: Compound; Process; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jul 9, 2012
Apr 12, 2021U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
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, 2024U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes

ALMIRALL
SEYSARA (TABLET) (ORAL) SARECYCLINE HYDROCHLORIDE
NDA Applicant: ALMIRALL      NDA No.: 209521  Prod. No.: 001 RX (EQ 60MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)
PatentsExpirationPatented 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, 2031U-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, 2029U-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, 2033U-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, 2028U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 1, 2023 

ALMIRALL
SOLAGE (SOLUTION) (TOPICAL) MEQUINOL; TRETINOIN
Drug Classes: skin lightening agent; retinoid
NDA Applicant: ALMIRALL      NDA No.: 020922  Prod. No.: 001 DISC (2%;0.01%)
PatentsExpirationPatented Use
Pat. No. 6353029 Storage stable tretinoin and 4-hydroxyanisole containing topical composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Aug 24, 2020 

ALMIRALL
VERDESO (AEROSOL, FOAM) (TOPICAL) DESONIDE
Drug Classes: corticosteroid
NDA Applicant: ALMIRALL      NDA No.: 021978  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 6730288 DP* Mousse composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Sep 8, 2019 
Pat. No. 7029659 DP* Mousse composition
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: None
Sep 8, 2019 
Pat. No. 8460641 DP* Microemulsion process and composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 5, 2013
Aug 13, 2027U-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, 2025U-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, 2025U-1412: Treatment of atopic dermatitis

ALMIRALL
XOLEGEL (GEL) (TOPICAL) KETOCONAZOLE
Drug Classes: azole antifungal
NDA Applicant: ALMIRALL      NDA No.: 021946  Prod. No.: 001 RX (2%)
PatentsExpirationPatented Use
Pat. No. 8232276 DP* Anhydrous topical skin preparations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 20, 2012
Nov 24, 2020 

ALNYLAM PHARMS INC
ONPATTRO (SOLUTION) (INTRAVENOUS) PATISIRAN SODIUM
NDA Applicant: ALNYLAM PHARMS INC      NDA No.: 210922  Prod. No.: 001 RX (EQ 10MG BASE/5ML (EQ 2MG BASE/ML))
PatentsExpirationPatented 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, 2030U-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, 2029U-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. 8362231 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
Pat. No. 8372968 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Compound; Product-by-process; Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
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. 8552171 DS* DP* RNA sequence-specific mediators of RNA interference
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
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, 2029U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 8778902 RNA interference mediating small RNA molecules
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021U-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, 2030U-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, 2029U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 8895718 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
Pat. No. 8895721 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
Pat. No. 9193753 RNA sequence-specific mediators of RNA interference
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021U-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, 2029U-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, 2029U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis
Pat. No. 9567582 DS* DP* RNA interference mediating small RNA molecules
Claim Types: Composition
Pat. Sub. Date(s): 001: Sep 6, 2018
Mar 30, 2021 
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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 10, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityAug 10, 2025ODE-197: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

ALPHARMA PHARMS
EMBEDA (CAPSULE, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Drug Classes: dopaminergic agonist; opioid agonist; opioid antagonist
NDA Applicant: ALPHARMA PHARMS      NDA No.: 022321  Prod. No.: 001 RX (20MG;0.8MG); 002 RX (30MG;1.2MG); 003 RX (50MG;2MG); 004 RX (60MG;2.4MG); 005 RX (80MG;3.2MG); 006 RX (100MG;4MG)
PatentsExpirationPatented Use
Pat. No. 7682633 Pharmaceutical composition
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 19, 2027U-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, 2027U-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, 2029U-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, 2025U-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 

ALVOGEN
FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
Drug Classes: aminoketone
NDA Applicant: ALVOGEN      NDA No.: 022497  Prod. No.: 001 RX (450MG)
PatentsExpirationPatented 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 

ALYVANT
NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator; vasopressin analog
NDA Applicant: ALYVANT      NDA No.: 201656  Prod. No.: 001 DISC (0.00083MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 7405203 Pharmaceutical compositions including low dosages of desmopressin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 31, 2017
May 6, 2023U-1980: A method of treating nocturia due to nocturnal polyuria in adults
Pat. No. 7579321 Pharmaceutical compositions including low dosages of desmopressin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 31, 2017
May 6, 2023U-1980: A method of treating nocturia due to nocturnal polyuria in adults
Pat. No. 7799761 DP* Pharmaceutical compositions including low dosages of desmopressin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 31, 2017
Sep 26, 2024 
Pat. No. 9539302 DP* Safe desmopressin administration
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 31, 2017
Jun 15, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 3, 2020 

ALYVANT
NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator; vasopressin analog
NDA Applicant: ALYVANT      NDA No.: 201656  Prod. No.: 002 DISC (0.00166MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 7405203 Pharmaceutical compositions including low dosages of desmopressin
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 31, 2017
May 6, 2023U-1980: A method of treating nocturia due to nocturnal polyuria in adults
Pat. No. 7579321 Pharmaceutical compositions including low dosages of desmopressin
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 31, 2017
May 6, 2023U-1980: A method of treating nocturia due to nocturnal polyuria in adults
Pat. No. 9539302 DP* Safe desmopressin administration
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 31, 2017
Jun 15, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 3, 2020 

ALZA
TESTODERM TTS (FILM, EXTENDED RELEASE) (TRANSDERMAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ALZA      NDA No.: 020791  Prod. No.: 001 DISC (5MG/24HR)
PatentsExpirationPatented Use
Pat. No. 6348210 Methods for transdermal drug administration
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Nov 10, 2019U-440: Method for transdermal administration of a drug through non-scrotal skin using a transdermal drug delivery device containing the drug and having an adhesive surface

AM REGENT
INJECTAFER (INJECTABLE) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))
PatentsExpirationPatented 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 DP* Methods and compositions for administration of iron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 12, 2013
Feb 15, 2028U-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
Pat. No. 8895612 DP* 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, 2027U-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.
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 

AM REGENT
SELENIOUS ACID (SOLUTION) (INTRAVENOUS) SELENIOUS ACID
NDA Applicant: AM REGENT      NDA No.: 209379  Prod. No.: 001 RX (EQ 600MCG BASE/10ML (EQ 60MCG BASE/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 30, 2024 

AMAG PHARMA USA
MAKENA (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) HYDROXYPROGESTERONE CAPROATE
Drug Classes: progestin
NDA Applicant: AMAG PHARMA USA      NDA No.: 021945  Prod. No.: 004 RX (275MG/1.1ML (250MG/ML))
PatentsExpirationPatented Use
Pat. No. RE44846 DP* Needle assisted jet injector
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 2, 2018
Aug 10, 2019 
Pat. No. 8021335 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 2, 2018
Oct 4, 2026 
Pat. No. 8562564 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 2, 2018
Jan 24, 2026 
Pat. No. 9180259 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 2, 2018
Jan 24, 2026 
Pat. No. 9533102 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 2, 2018
Jan 24, 2026 
Pat. No. 9629959 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 2, 2018
Jan 24, 2026 
Pat. No. 9789257 DP* Needle assisted injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): 004: Mar 2, 2018
Feb 11, 2034 
Pat. No. 9844558 Methods of reducing risk of preterm birth
Claim Types: Method of use
Pat. Sub. Date(s): 004: Mar 2, 2018
May 2, 2036U-2236: Reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth

AMAG PHARMS INC
FERAHEME (SOLUTION) (INTRAVENOUS) FERUMOXYTOL
Drug Classes: iron replacement product
NDA Applicant: AMAG PHARMS INC      NDA No.: 022180  Prod. No.: 001 RX (EQ 510MG IRON/17ML (EQ 30MG IRON/ML))
PatentsExpirationPatented Use
Pat. No. 6599498 DS* DP* [Extended 1209 days (3.3 years)]
Heat stable colloidal iron oxides coated with reduced carbohydrates and carbohdrate derivatives
Claim Types: Method of administration; Process; Formulation
Pat. Sub. Date(s): 001: None
Jun 30, 2023 
Pat. No. 7553479 DS* DP* Heat stable colloidal iron oxides coated with reduced carbohydrates and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Mar 8, 2020 
Pat. No. 7871597 DS* DP* Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 15, 2011
Mar 8, 2020 
Pat. No. 8501158 Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 6, 2013
Mar 8, 2020U-1422: Method of treating patients needing an iron supplement
Pat. No. 8591864 DP* Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 12, 2013
Mar 8, 2020 
Pat. No. 8926947 DS* DP* Polyol and polyether iron oxide complexes as pharmacological and/or MRI contrast agents
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Jan 8, 2015
Mar 8, 2020 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFeb 2, 2021I-767: Treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron

AMAG PHARMS INC
INTRAROSA (INSERT) (VAGINAL) PRASTERONE
NDA Applicant: AMAG PHARMS INC      NDA No.: 208470  Prod. No.: 001 RX (6.5MG)
PatentsExpirationPatented Use
Pat. No. 8268806 DP* Pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 8, 2016
Mar 19, 2031 
Pat. No. 8629129 DP* Pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 8, 2016
Aug 7, 2028 
Pat. No. 8957054 Pharmaceutical compositions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 8, 2016
Aug 7, 2028U-1922: Intravaginal PRASTERONE (dehydroepiandrosterone) at a daily dose of 6.5mg for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 16, 2021 

AMAG PHARMS INC
VYLEESI (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) BREMELANOTIDE ACETATE
NDA Applicant: AMAG PHARMS INC      NDA No.: 210557  Prod. No.: 001 RX (EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML))
PatentsExpirationPatented Use
Pat. No. 6579968 DS* DP* Compositions and methods for treatment of sexual dysfunction
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 10, 2019
Jun 28, 2020 
Pat. No. 6794489 DS* DP* Compositions and methods for treatment of sexual dysfunction
Claim Types: Composition; Method of use; Compound; Kit
Pat. Sub. Date(s): 001: Jul 10, 2019
Jun 28, 2020 
Pat. No. 9352013 Uses of bremelanotide in therapy for female sexual dysfunction
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 10, 2019
Nov 5, 2033U-2568: Treatment of hypoactive sexual desire disorder (HSDD)
Pat. No. 9700592 Uses of bremelanotide in therapy for female sexual dysfunction
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 10, 2019
Nov 5, 2033U-2568: Treatment of hypoactive sexual desire disorder (HSDD)
Pat. No. 10286034 Uses of bremelanotide in therapy for female sexual dysfunction
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 10, 2019
Nov 5, 2033U-2568: Treatment of hypoactive sexual desire disorder (HSDD)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 21, 2024 

AMARIN PHARMS
VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL
NDA Applicant: AMARIN PHARMS      NDA No.: 202057  Prod. No.: 001 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 8188146 DS* DP* Highly purified ethyl EPA and other EPA derivatives
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 27, 2020 
Pat. No. 8293727 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8415335 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 17, 2013
Feb 9, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2030U-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, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8501225 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8518929 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8524698 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 11, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8546372 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 1, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8551521 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 9, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8563608 Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8617593 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2014
Apr 29, 2030U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia
Pat. No. 8617594 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8623406 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2014
Apr 29, 2030U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia

AMARIN PHARMS
VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL
NDA Applicant: AMARIN PHARMS      NDA No.: 202057  Prod. No.: 002 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 8188146 DS* DP* Highly purified ethyl EPA and other EPA derivatives
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 26, 2017
Jan 27, 2020 
Pat. No. 8293727 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Apr 29, 2030 
Pat. No. 8314086 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8415335 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Feb 9, 2030U-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): 002: Jun 26, 2017
Apr 29, 2030U-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): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8501225 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8518929 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8524698 Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8546372 Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8551521 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8563608 Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8617593 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8617594 Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8623406 Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia

AMGEN
SENSIPAR (TABLET) (ORAL) CINACALCET HYDROCHLORIDE [GENERIC AB]
Drug Classes: calcium-sensing receptor agonist
NDA Applicant: AMGEN      NDA No.: 021688  Prod. No.: 001 RX (EQ 30MG BASE); 002 RX (EQ 60MG BASE); 003 RX (EQ 90MG BASE)
PatentsExpirationPatented Use
Pat. No. 7829595 DP* Rapid dissolution formulation of a calcium receptor-active compound
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 2, 2010; 002: None; 003: None
Sep 22, 2026U-1098: Method of treating hyperparathyroidism; method of treating hypercalcemia
Pat. No. 9375405 DP* Rapid dissolution formulation of a calcium receptor-active compound
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 22, 2016
Sep 22, 2026 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 23, 2020M-200: Clinical information added to the use in specific populations section of the labeling.
Exclusivity Code: ODE - Orphan drug exclusivityNov 21, 2021ODE-78: Treatment of hypercalcemia in adult patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.

AMGEN INC
CORLANOR (TABLET) (ORAL) IVABRADINE HYDROCHLORIDE
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: AMGEN INC      NDA No.: 206143  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 7.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 7361649 DS* DP* .beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: May 11, 2015
Aug 22, 2026 *PEDU-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7361650 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: May 11, 2015
Aug 22, 2026 *PEDU-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7867996 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): All strengths: May 11, 2015
Aug 22, 2026 *PEDU-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7879842 DS* DP* Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: May 11, 2015
Aug 22, 2026 *PEDU-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 15, 2020 PED 

AMGEN INC
CORLANOR (SOLUTION) (ORAL) IVABRADINE
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: AMGEN INC      NDA No.: 209964  Prod. No.: 001 RX (5MG/5ML (1MG/ML))
PatentsExpirationPatented Use
Pat. No. 7361649 DS* DP* .beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: May 3, 2019
Feb 22, 2026U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7361650 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: May 3, 2019
Feb 22, 2026U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7867996 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: May 3, 2019
Feb 22, 2026U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
Pat. No. 7879842 DS* DP* Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 001: May 3, 2019
Feb 22, 2026U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOct 15, 2020 PED 
Exclusivity Code: NP - New productOct 22, 2022 PED 
Exclusivity Code: ODE - Orphan drug exclusivityOct 22, 2026 PEDODE-234: Indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate

AMICUS THERAPS US
GALAFOLD (CAPSULE) (ORAL) MIGALASTAT HYDROCHLORIDE
NDA Applicant: AMICUS THERAPS US      NDA No.: 208623  Prod. No.: 001 RX (EQ 123MG BASE)
PatentsExpirationPatented Use
Pat. No. 8592362 Method to predict response to pharmacological chaperone treatment of diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
Feb 12, 2029U-2371: The treatment of Fabry patients
Pat. No. 9000011 Methods for treatment of Fabry disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
May 16, 2027U-2371: The treatment of Fabry patients
Pat. No. 9095584 Method to predict response to pharmacological chaperone treatment of diseases
Claim Types: Method of use; Diagnostic or surgical method
Pat. Sub. Date(s): 001: Sep 5, 2018
Feb 12, 2029U-2371: The treatment of Fabry patients
Pat. No. 9480682 Methods for treatment of Fabry disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
May 16, 2027U-2371: The treatment of Fabry patients
Pat. No. 9987263 Methods for treatment of Fabry disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
May 16, 2027U-2371: The treatment of Fabry patients
Pat. No. 9999618 Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 5, 2018
Apr 28, 2028U-2372: A method of reducing left ventricular mass index (LVMI) in a Fabry patient by administering migalastat
U-2373: A method of reducing podocyte globotriaosylceramide (GL-3) in a Fabry patient by administering migalastat
Pat. No. 10076514 Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 18, 2018
Mar 15, 2037U-2371: The treatment of Fabry patients
Pat. No. 10251873 Methods of treating Fabry patients having renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 7, 2019
May 30, 2038U-2371: The treatment of Fabry patients
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAug 10, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityAug 10, 2025ODE-205: Indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data

AMNEAL PHARMS
ABIRATERONE ACETATE (TABLET) (ORAL) ABIRATERONE ACETATE [GENERIC AB]
Drug Classes: CYP17 inhibitor
NDA Applicant: AMNEAL PHARMS      NDA No.: 208327  Prod. No.: 001 RX (250MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeApr 29, 2019 

AMNEAL PHARMS
AMPHETAMINE SULFATE (TABLET) (ORAL) AMPHETAMINE SULFATE [GENERIC AA]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: AMNEAL PHARMS      NDA No.: 211139  Prod. No.: 001 RX (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyMar 26, 2019 

AMNEAL PHARMS
AMPHETAMINE SULFATE (TABLET) (ORAL) AMPHETAMINE SULFATE [GENERIC AA]
Drug Classes: central nervous system stimulant; adrenergic agonist; amphetamine anorectic
NDA Applicant: AMNEAL PHARMS      NDA No.: 211139  Prod. No.: 002 RX (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyMar 30, 2019 

AMNEAL PHARMS
ITRACONAZOLE (SOLUTION) (ORAL) ITRACONAZOLE [GENERIC AA]
Drug Classes: azole antifungal
NDA Applicant: AMNEAL PHARMS      NDA No.: 205573  Prod. No.: 001 RX (10MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: PC - Patent challengeMar 17, 2019 

AMNEAL PHARMS
METHYLERGONOVINE MALEATE (TABLET) (ORAL) METHYLERGONOVINE MALEATE [GENERIC AB]
Drug Classes: ergot derivative
NDA Applicant: AMNEAL PHARMS      NDA No.: 211483  Prod. No.: 001 RX (0.2MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyMar 20, 2019 

AMNEAL PHARMS LLC
TIGECYCLINE (POWDER) (INTRAVENOUS) TIGECYCLINE [GENERIC AP]
Drug Classes: tetracycline class antibacterial
NDA Applicant: AMNEAL PHARMS LLC      NDA No.: 211158  Prod. No.: 001 RX (50MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 9855335 DP* Tigecycline composition for injection
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Sep 19, 2018
Apr 7, 2033 

ANACOR PHARMS INC
EUCRISA (OINTMENT) (TOPICAL) CRISABOROLE
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ANACOR PHARMS INC      NDA No.: 207695  Prod. No.: 001 RX (2%)
PatentsExpirationPatented Use
Pat. No. 8039451 DS* DP* Boron-containing small molecules
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 12, 2017
Jun 11, 2026 
Pat. No. 8168614 Boron-containing small molecules as anti-inflammatory agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 12, 2017
Jan 20, 2030U-1932: Method of treating mild to moderate atopic dermatitis.
Pat. No. 8501712 Boron-containing small molecules as anti-inflammatory agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 12, 2017
Feb 16, 2027U-1932: Method of treating mild to moderate atopic dermatitis.
Pat. No. 9682092 Boron-containing small molecules as anti-inflammatory agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 14, 2017
Feb 16, 2027U-1932: Method of treating mild to moderate atopic dermatitis.
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 14, 2021 

ANACOR PHARMS INC
KERYDIN (SOLUTION) (TOPICAL) TAVABOROLE
Drug Classes: oxaborole antifungal
NDA Applicant: ANACOR PHARMS INC      NDA No.: 204427  Prod. No.: 001 RX (5%)
PatentsExpirationPatented Use
Pat. No. 7582621 DLR* Boron-containing small molecules
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 21, 2014
Nov 26, 2027 *PEDU-2016: Treatment for onychomycosis that is tinea unguium
U-2016: Treatment for onychomycosis that is tinea unguium
U-718: Treatment of fungal infections
Pat. No. 9549938 Boron-containing small molecules
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 6, 2017
Aug 16, 2026 *PEDU-1951: Treatment of onychomycosis of a toenail
Pat. No. 9566289 DP* Boron-containing small molecules
Claim Types: Formulation; Composition
Pat. Sub. Date(s): 001: Feb 21, 2017
Aug 16, 2026 *PED 
Pat. No. 9566290 Boron-containing small molecules
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2017
Aug 16, 2026 *PEDU-1970: Treatment of onychomychosis of a toenail caused by trichophyton rubrum or trichophyton mentagrophytes
Pat. No. 9572823 Boron-containing small molecules
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 17, 2017
Aug 16, 2026 *PEDU-1970: Treatment of onychomychosis of a toenail caused by trichophyton rubrum or trichophyton mentagrophytes
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJan 7, 2020 PED 

ANDRX LABS LLC
FORTAMET (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE
Drug Classes: biguanide
NDA Applicant: ANDRX LABS LLC      NDA No.: 021574  Prod. No.: 001 DISC (500MG**); 002 DISC (1GM**)
PatentsExpirationPatented Use
Pat. No. 6790459 Methods for treating diabetes via administration of controlled release metformin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Mar 17, 2021U-604: Method of lowering blood glucose by once daily administration
Pat. No. 6866866 DP* Controlled release metformin compositions
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: None
Mar 17, 2021 

ANGELINI PHARMA
OLEPTRO (TABLET, EXTENDED RELEASE) (ORAL) TRAZODONE HYDROCHLORIDE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ANGELINI PHARMA      NDA No.: 022411  Prod. No.: 001 DISC (150MG**); 002 DISC (300MG**)
PatentsExpirationPatented Use
Pat. No. 6607748 DP* Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Jun 29, 2020 
Pat. No. 7829120 DP* Trazodone composition for once a day administration
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 6, 2010; 002: None
Mar 27, 2027U-796: Method of treating depression
Pat. No. 8133893 DS* DP* Trazodone and trazodone hydrochloride in purified form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 16, 2012; 002: None
Mar 13, 2029 

ANI PHARMS INC
INNOPRAN XL (CAPSULE, EXTENDED RELEASE) (ORAL) PROPRANOLOL HYDROCHLORIDE [Has competitive generic]
Drug Classes: beta-adrenergic receptor inhibitor
NDA Applicant: ANI PHARMS INC      NDA No.: 021438  Prod. No.: 001 RX (80MG); 002 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 6500454 DP* Timed, sustained release systems for propranolol
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 18, 2003; 002: None
Oct 4, 2021 

ANTARES PHARMA INC
OTREXUP (SOLUTION) (SUBCUTANEOUS) METHOTREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ANTARES PHARMA INC      NDA No.: 204824  Prod. No.: 001 RX (10MG/0.4ML (10MG/0.4ML)); 002 RX (15MG/0.4ML (15MG/0.4ML)); 003 RX (20MG/0.4ML (20MG/0.4ML)); 004 RX (25MG/0.4ML (25MG/0.4ML))
PatentsExpirationPatented Use
Pat. No. RE44847 DP* Needle assisted jet injector
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 13, 2014
Aug 10, 2019U-1442: Subcutaneous injection of methotrexate
Pat. No. RE44846 DP* Needle assisted jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 13, 2014
Aug 10, 2019 
Pat. No. 6746429 DP* Needle assisted jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 4, 2013
Apr 12, 2020 
Pat. No. 7744582 DP* Needle assisted jet injector
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 4, 2013; 002: None; 003: None; 004: None
Aug 10, 2019U-1442: Subcutaneous injection of methotrexate
Pat. No. 7776015 DP* Needle assisted jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 4, 2013
Aug 10, 2019 
Pat. No. 8021335 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 4, 2013
Oct 4, 2026 
Pat. No. 8480631 DP* Hazardous agent injection system
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Nov 4, 2013; 002: None; 003: None; 004: None
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 8562564 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 4, 2013
Jan 24, 2026 
Pat. No. 8579865 DP* Hazardous agent injection system
Claim Types: Device; Method of use
Pat. Sub. Date(s): All strengths: Nov 21, 2013
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 8945063 DP* Hazardous agent injection system
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Mar 2, 2015
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 9421333 DP* Hazardous agent injection system
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2016
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 9533102 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Feb 2, 2017
Jan 24, 2026 
Pat. No. 9629959 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 25, 2017
Jan 24, 2026 

ANTARES PHARMA INC
OTREXUP (SOLUTION) (SUBCUTANEOUS) METHOTREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ANTARES PHARMA INC      NDA No.: 204824  Prod. No.: 006 RX (12.5MG/0.4ML (12.5MG/0.4ML)); 007 RX (17.5MG/0.4ML (17.5MG/0.4ML)); 008 RX (22.5MG/0.4ML (22.5MG/0.4ML)) NDA No.: 204824  Prod. No.: 005 DISC (7.5MG/0.4ML (7.5MG/0.4ML))
PatentsExpirationPatented Use
Pat. No. RE44847 DP* Needle assisted jet injector
Claim Types: Method of use
Pat. Sub. Date(s): 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016
Aug 10, 2019U-1442: Subcutaneous injection of methotrexate
Pat. No. RE44846 DP* Needle assisted jet injector
Claim Types: Device
Pat. Sub. Date(s): 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016
Aug 10, 2019 
Pat. No. 6746429 DP* Needle assisted jet injector
Claim Types: Device
Pat. Sub. Date(s): 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016
Apr 12, 2020 
Pat. No. 8021335 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016
Oct 4, 2026 
Pat. No. 8480631 DP* Hazardous agent injection system
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 8562564 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016
Jan 24, 2026 
Pat. No. 8579865 DP* Hazardous agent injection system
Claim Types: Device; Method of use
Pat. Sub. Date(s): 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 8945063 DP* Hazardous agent injection system
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 005: Mar 2, 2015; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 9421333 DP* Hazardous agent injection system
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2016
Mar 19, 2030U-1442: Subcutaneous injection of methotrexate
Pat. No. 9533102 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Feb 2, 2017
Jan 24, 2026 
Pat. No. 9629959 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 25, 2017
Jan 24, 2026 

ANTARES PHARMA INC
XYOSTED (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TESTOSTERONE ENANTHATE
Drug Classes: androgen
NDA Applicant: ANTARES PHARMA INC      NDA No.: 209863  Prod. No.: 001 RX (50MG/0.5ML (50MG/0.5ML)); 002 RX (75MG/0.5ML (75MG/0.5ML)); 003 RX (100MG/0.5ML (100MG/0.5ML))
PatentsExpirationPatented Use
Pat. No. RE44847 DP* Needle assisted jet injector
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Aug 10, 2019U-2419: Method of operating an injection device
Pat. No. RE44846 DP* Needle assisted jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Aug 10, 2019 
Pat. No. 8021335 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Oct 4, 2026 
Pat. No. 8562564 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9180259 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9533102 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9629959 DP* Prefilled syringe jet injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Jan 24, 2026 
Pat. No. 9744302 DP* Needle assisted jet injection device having reduced trigger force
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Nov 19, 2035 
Pat. No. 9950125 DP* Needle assisted jet injection administration of testosterone compositions
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Oct 24, 2018
Sep 4, 2036U-2418: Method of administering testosterone enanthate subcutaneously
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productSep 28, 2021 

APGDI
MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI      NDA No.: 202611  Prod. No.: 001 RX (25MG); 002 RX (50MG)
PatentsExpirationPatented Use
Pat. No. RE44872 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 16, 2014
Nov 4, 2023U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 6346532 DS* DP* [Extended 1259 days (3.4 years)]
Amide derivatives or salts thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
Mar 27, 2022 
Pat. No. 6562375 DP* Stable pharmaceutical composition for oral use
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
Aug 1, 2020 
Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
Nov 4, 2023 
Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative
Claim Types: Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None
Nov 4, 2023 
Pat. No. 8772315 Pharmaceutical composition for treating overactive bladder
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 17, 2018
Oct 30, 2028U-2300: Use in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Pat. No. 8835474 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2014
Nov 4, 2023U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 27, 2021I-777: Co-administration therapy of mirabegron with solifenacin succinate for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

APIL
ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 003 RX (35MG)
PatentsExpirationPatented Use
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: None
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
Pat. Sub. Date(s): 003: None
Jan 17, 2019 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 6432932 Method for inhibiting bone resorption
Claim Types: Method of use
Pat. Sub. Date(s): 003: None
Jan 17, 2019 *PEDU-595: 35 mg orally once a week for prevention of osteoporosis in postmenopausal women; 35 mg orally once a week for treatment of osteoporosis in postmenopausal women
Pat. No. 6465443 DP* Method for inhibiting bone resorption
Claim Types: Composition; Kit
Pat. Sub. Date(s): 003: None
Feb 14, 2019 *PED 

APIL
ACTONEL (TABLET) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL      NDA No.: 020835  Prod. No.: 005 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 7192938 Method of treatment using bisphosphonic acid
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Nov 6, 2023 *PEDU-353: Prevention and treatment of osteoporosis
Pat. No. 7718634 Method of treatment using bisphosphonic acid
Claim Types: Method of use
Pat. Sub. Date(s): 005: None
Nov 6, 2023 *PEDU-662: Treatment of osteoporosis in postmenopausal women

APIL
ASACOL HD (TABLET, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: APIL      NDA No.: 021830  Prod. No.: 001 RX (800MG)
PatentsExpirationPatented Use
Pat. No. 6893662 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Nov 15, 2021U-141: Treatment of ulcerative colitis
Pat. No. 8580302 DP* Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Claim Types: <