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.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Jan 26, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 26, 2025 | ODE-166: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS) including foregut, midgut, and hindgut neuroendocrine tumors in adults |
AAA USA INC
NETSPOT (POWDER) (INTRAVENOUS) GALLIUM DOTATATE GA-68
NDA Applicant: AAA USA INC NDA No.: 208547 Prod. No.: 001 RX (2.1-5.5mCi/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9375498 DP* Process for the preparation of complexes of .sup.68Ga Claim Types: Kit; Product-by-process; Drug in a container; Process Pat. Sub. Date(s): 001: Jul 9, 2018 | Aug 10, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 1, 2021 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 1, 2023 | ODE-120: For use after radiolabeling with Ga 68, with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. |
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)
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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 *PED | U-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))
| Patents | Expiration | Patented 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 *PED | U-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, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8466138 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8486925 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2013 | Oct 12, 2026 | |
| Pat. No. 8729057 DP* Testosterone gel and method of use Claim Types: Composition Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014 | Oct 12, 2026 | |
| Pat. No. 8741881 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2014 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8754070 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 16, 2014 | Oct 12, 2026 | |
| Pat. No. 8759329 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 9, 2014 | Oct 12, 2026 | |
| 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 *PED | U-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 *PED | U-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**)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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, 2030 | U-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)
| Patents | Expiration | Patented 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, 2030 | U-1787: Treatment of exocrine pancreatic insufficiency |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jul 29, 2019 | M-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)
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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)
| Patents | Expiration | Patented 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 *PED | U-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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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 *PED | U-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)
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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 *PED | U-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 *PED | U-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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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)
| Patents | Expiration | Patented 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, 2020 | U-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, 2023 | U-847: Adjunctive therapy to diet in adults to reduce LDL-c, triglycerides and Apo b, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V) |
ABBVIE
TRILIPIX (CAPSULE, DELAYED RELEASE) (ORAL) CHOLINE FENOFIBRATE [GENERIC AB]
NDA Applicant: ABBVIE NDA No.: 022224 Prod. No.: 001 RX (EQ 45MG FENOFIBRIC ACID); 002 RX (EQ 135MG FENOFIBRIC ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7259186 DS* Salts of fenofibric acid and pharmaceutical formulations thereof Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Jan 7, 2025 |
ABBVIE
ZEMPLAR (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**)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Oct 18, 2019 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 18, 2023 | ODE-125: Indicated in pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4 and ckd stage 5 in patients on hemodialysis or peritoneal dialysis |
ABBVIE ENDOCRINE INC
LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC NDA No.: 020517 Prod. No.: 003 RX (45MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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, 2031 | U-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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 9, 2022 | ODE-84: Treatment of motor fluctuations in patients with advanced Parkinson's disease |
ABBVIE INC
MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor; hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: ABBVIE INC NDA No.: 209394 Prod. No.: 001 RX (100MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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, 2032 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2034 | 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Aug 6, 2021 | M-230: Revisions to the glecaprevir/pibrentasvir combination product prescribing information to include safety and efficacy data from the HCV/HIV-1 coinfection study M14-730 and from the liver and renal transplant study M13-596 |
| Exclusivity Code: NCE - New chemical entity | Aug 3, 2022 | |
| Exclusivity Code: NPP - New patient population | Apr 30, 2022 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 30, 2026 | ODE-232: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 30, 2026 | ODE-233: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 7, 2024 | ODE-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)
| Patents | Expiration | Patented 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, 2024 | U-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, 2021 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Aug 20, 2018 | Jul 6, 2024 | U-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, 2021 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 23, 2023 |
ABBVIE INC
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
NDA Applicant: ABBVIE INC NDA No.: 211675 Prod. No.: 001 RX (EQ 15MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Aug 16, 2024 |
ABBVIE INC
TECHNIVIE (TABLET) (ORAL) OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: hepatitis C virus (HCV) NS5A inhibitor; hepatitis C virus (HCV) NS3/4A protease inhibitor; CYP3A inhibitor; HIV protease inhibitor
NDA Applicant: ABBVIE INC NDA No.: 207931 Prod. No.: 001 DISC (12.5MG;75MG;50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 6, 2015 | Apr 13, 2032 | |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2015 | Jun 10, 2030 | U-1687: Treatment of hcv infection using ombitasvir |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 6, 2015 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8546399 DS* DP* Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 4, 2016 | Jun 27, 2031 | |
| Pat. No. 9174982 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 4, 2016 | May 26, 2030 | U-2323: Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy U-2445: Treatment in combination with azacitidine or decitabine or low-dose cytarabine of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy U-2446: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
| Pat. No. 9539251 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2019 | Sep 6, 2033 | U-2538: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (Sll) in combination with a GA101 antibody such as obinutuzumab for one or more dosing periods, wherein the CLL or SLL is a CD20-expressing cancer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 8, 2021 | I-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 Indication | Nov 21, 2021 | I-789: Venetoclax in combo with azacitidine or decitabine or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy |
| Exclusivity Code: I - New Indication | May 15, 2022 | I-795: Venetoclax in combination with obinutuzumab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma |
| Exclusivity Code: M - Miscellaneous | Jun 8, 2021 | M-228: Information added to the package insert regarding the revision of the monotherapy indication of venetoclax |
| Exclusivity Code: NCE - New chemical entity | Apr 11, 2021 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 11, 2023 | ODE-114: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2025 | ODE-185: Indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 21, 2025 | ODE-211: Indicated in combo with azacitidine, or decitabine, or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 15, 2026 | ODE-239: Treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
ABBVIE INC
VIEKIRA PAK (COPACKAGED) (TABLET, 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)
| Patents | Expiration | Patented 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, 2029 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 25, 2024 | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Aug 25, 2024 | |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 10, 2031 | |
| Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1637: Treatment of hcv infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 17, 2028 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1637: Treatment of hcv infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jan 15, 2015 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 15, 2015 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 15, 2015 | Apr 13, 2032 | |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: May 6, 2015 | Jun 10, 2030 | U-1687: Treatment of hcv infection using ombitasvir |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 1, 2015 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2015 | Nov 9, 2028 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 9629841 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jun 16, 2017 | Oct 18, 2033 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 10201542 DP* Formulations of pyrimidinedione derivative compounds Claim Types: Formulation; Method of use; Process; Method of improving a treatment Pat. Sub. Date(s): 001: Mar 14, 2019 | Oct 18, 2033 | U-1753: Treatment of HCV infection using dasabuvir |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Apr 22, 2019 | D-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 entity | Dec 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)
| Patents | Expiration | Patented 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, 2029 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Aug 25, 2024 | |
| Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Aug 25, 2024 | |
| Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 10, 2031 | |
| Pat. No. 8466159 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1637: Treatment of hcv infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8492386 Methods for treating HCV Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8501238 DS* DP* Anti-infective agents and uses thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 17, 2028 | U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection. |
| Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 10, 2029 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 8680106 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1637: Treatment of hcv infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin. |
| Pat. No. 8685984 Methods for treating HCV Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Sep 4, 2032 | U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 17, 2016 | Jun 9, 2031 | |
| Pat. No. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 13, 2032 | |
| Pat. No. 9006387 Anti-viral compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Jun 10, 2030 | U-1687: Treatment of hcv infection using ombitasvir |
| Pat. No. 9044480 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Apr 10, 2031 | U-1638: Treatment of HCV infection using paritaprevir |
| Pat. No. 9139536 Anti-infective agents and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Nov 9, 2028 | U-1753: Treatment of HCV infection using dasabuvir |
| Pat. No. 9333204 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 17, 2016 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 9744170 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 27, 2017 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 10105365 DP* Solid antiviral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 20, 2018 | Jan 2, 2035 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Pat. No. 10201541 DP* Compositions and methods for treating HCV Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 14, 2019 | May 17, 2032 | |
| Pat. No. 10201584 Compositions and methods for treating HCV Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 14, 2019 | May 17, 2032 | U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2013 | Feb 21, 2026 | U-1434: Treatment of pancreatic cancer |
| Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 12, 2010 | Oct 27, 2024 | U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 15, 2011 | Dec 9, 2023 | U-1117: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Aug 13, 2026 | U-1290: Treatment of lung cancer |
| Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents Claim Types: Formulation; Drug in a container; Method of administration Pat. Sub. Date(s): 001: Mar 27, 2012 | Dec 9, 2023 | U-1092: Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
| Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 | Feb 21, 2026 | U-1290: Treatment of lung cancer |
| Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2012 | Dec 9, 2023 | U-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, 2020 | U-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, 2026 | U-1434: Treatment of pancreatic cancer |
| Pat. No. 9393318 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2016 | Mar 4, 2032 | U-1290: Treatment of lung cancer |
| Pat. No. 9511046 Methods of treating pancreatic cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2016 | Jan 12, 2034 | U-1434: Treatment of pancreatic cancer |
| Pat. No. 9597409 Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2017 | Mar 4, 2032 | U-1290: Treatment of lung cancer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2020 | ODE-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)
| Patents | Expiration | Patented 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, 2021 | U-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, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: May 25, 2016 | Jun 3, 2028 | |
| Pat. No. 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, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 25, 2016 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 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, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 4, 2017 | Jul 27, 2022 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 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)
| Patents | Expiration | Patented 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, 2021 | U-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, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 002: Jul 25, 2018 | Jun 3, 2028 | |
| Pat. No. 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, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 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, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 9765053 Methods of treatment using selective 5-HT2A inverse agonists Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jul 27, 2022 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 002: Jul 25, 2018 | Jan 15, 2024 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 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)
| Patents | Expiration | Patented 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, 2021 | U-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, 2026 | U-1844: Treatment of Parkinson's disease psychosis |
| Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: Jul 25, 2018 | Jun 3, 2028 | |
| Pat. No. 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, 2024 | U-1845: Treatment of psychosis or a symptom thereof |
| Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | U-1846: Treatment of a neurodegenerative disease or a symptom thereof |
| Pat. No. 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, 2022 | U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis |
| Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2018 | Jan 15, 2024 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Mar 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jan 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8202535 Small-volume oral transmucosal dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Oct 22, 2030 | U-1351: Treatment of acute pain |
| Pat. No. 8226978 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8231900 DP* Small-volume oral transmucosal dosage Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | |
| Pat. No. 8252328 DP* Bioadhesive drug formulations for oral transmucosal delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | |
| Pat. No. 8252329 DP* Bioadhesive drug formulations for oral transmucosal delivery Claim Types: Formulation; Device Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | |
| Pat. No. 8535714 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8574189 DP* Storage and dispensing devices for administration of oral transmucosal dosage forms Claim Types: Device Pat. Sub. Date(s): 001: Nov 28, 2018 | Mar 16, 2030 | |
| Pat. No. 8778393 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8778394 Small-volume oral transmucosal dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8865211 Bioadhesive drug formulations for oral transmucosal delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 8865743 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Oct 22, 2030 | U-1351: Treatment of acute pain |
| Pat. No. 8945592 DP* Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same Claim Types: Drug in a container?; Method of reducing drug degration? Pat. Sub. Date(s): 001: Nov 28, 2018 | Jul 29, 2031 | |
| Pat. No. 9320710 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 9744129 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2018 | Jan 5, 2027 | |
| Pat. No. 10245228 DP* Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 19, 2019 | Jan 5, 2027 | U-1351: Treatment of acute pain |
| Pat. No. 10342762 DP* Small-volume oral transmucosal dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 23, 2019 | Jan 5, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Nov 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 DISC (40%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7381427 Seborrheic keratosis treatment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 3, 2018 | Jun 8, 2022 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 3, 2018 | Jul 4, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 18, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Apr 21, 2035 | U-2205: Treatment of seborrheic keratoses that are raised |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 14, 2020 |
ACLARIS
RHOFADE (CREAM) (TOPICAL) OXYMETAZOLINE HYDROCHLORIDE
Drug Classes: vasoconstrictor
NDA Applicant: ACLARIS NDA No.: 208552 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented 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, 2028 | U-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, 2024 | U-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, 2024 | U-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, 2035 | U-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, 2035 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jan 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8007826 Sustained release aminopyridine composition Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 28, 2011 | May 26, 2027 | U-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, 2026 | U-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, 2025 | U-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, 2025 | U-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, 2024 | U-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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43711 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Feb 3, 2029 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 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, 2020 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 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, 2020 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 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, 2021 | U-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, 2020 | U-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, 2020 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 7146978 Inhalation device and method Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Apr 16, 2021 | U-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, 2021 | U-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, 2023 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 8545878 DP* Capsules containing high doses of levodopa for pulmonary use Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 16, 2032 | |
| Pat. No. 8586093 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Mar 19, 2023 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 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, 2020 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Dec 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6888027 DS* DP* Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 1, 2014 | Sep 27, 2021 | U-1544: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). |
| Pat. No. 8835501 DP* Pharmaceutical formulations of HDAC inhibitors Claim Types: Formulation; Drug in a container; Kit Pat. Sub. Date(s): 001: Oct 9, 2014 | Oct 27, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 3, 2019 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 3, 2021 | ODE-68: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
ACROTECH
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: ACROTECH NDA No.: 207155 Prod. No.: 001 RX (EQ 50MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8410077 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Compound; Product-by-process; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016 | Mar 13, 2029 | |
| Pat. No. 9200088 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016 | Mar 13, 2029 | |
| Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Formulation; Product-by-process; Process Pat. Sub. Date(s): 001: Mar 14, 2017 | Feb 27, 2033 | |
| Pat. No. 10040872 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 6, 2018 | Jan 30, 2034 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 10, 2023 | ODE-110: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma |
ACROTECH
FOLOTYN (SOLUTION) (INTRAVENOUS) PRALATREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: ACROTECH NDA No.: 022468 Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (40MG/2ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6028071 DS* DP* [Extended 5 years] Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors Claim Types: Compound; Composition; Method of use; Formulation Pat. Sub. Date(s): All strengths: None | Jul 16, 2022 | U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
| Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 31, 2025 | U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
| Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None | May 31, 2025 | U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma |
ACROTECH
FUSILEV (POWDER; SOLUTION) (INTRAVENOUS) LEVOLEUCOVORIN CALCIUM [GENERIC AP]
NDA Applicant: ACROTECH NDA No.: 020140 Prod. No.: 001 RX (EQ 50MG BASE/VIAL) NDA No.: 020140 Prod. No.: 002 DISC (EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)**); 003 DISC (EQ 250MG BASE/25ML (EQ 10MG BASE/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6500829 DS* DP* [Extended 797 days (2.2 years)] Substantially pure diastereoisomers of tetrahydrofolate derivatives Claim Types: Formulation Pat. Sub. Date(s): 001: None; 002: May 9, 2011; 003: May 9, 2011 | Mar 7, 2022 |
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))
| Patents | Expiration | Patented 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, 2020 | U-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, 2020 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 9, 2019 | ODE-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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Apr 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Aug 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7959945 DP* Dispersible bosentan tablet Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 3, 2017 | Dec 28, 2027 | |
| Pat. No. 8309126 DP* Dispersible bosentan tablet Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Oct 3, 2017 | May 15, 2026 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 5, 2020 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 5, 2024 | ODE-161: Treatment of pulmonary arterial hypertension (PAH) (WHO group 1) in pediatric patients aged 3 yrs and older with idiopathic or congenital pah to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability |
ACTELION PHARMS LTD
OPSUMIT (TABLET) (ORAL) MACITENTAN
Drug Classes: endothelin receptor antagonist
NDA Applicant: ACTELION PHARMS LTD NDA No.: 204410 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7094781 DS* DP* [Extended 1150 days (3.2 years)] Sulfamides and their use as endothelin receptor antagonists Claim Types: Compound Pat. Sub. Date(s): 001: Nov 6, 2013 | Dec 5, 2025 | |
| Pat. No. 8268847 Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 6, 2013 | Apr 18, 2029 | U-1446: Method of treating pulmonary hypertension comprising administering macitentan in combination with a compound having phosphodiesterase-5 inhibitory properties |
| Pat. No. 8367685 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 6, 2013 | Oct 4, 2028 | U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition |
| Pat. No. 9265762 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 16, 2016 | May 29, 2027 | U-1820: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 3% of the weight of said pharmaceutical composition |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 18, 2020 | ODE-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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Sep 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7205302 DS* DP* Heterocyclic compound derivatives and medicines Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Apr 4, 2023 | U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag |
| Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Aug 1, 2030 | |
| Pat. No. 9173881 Therapeutic compositions containing macitentan Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Aug 12, 2029 | U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan |
| Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 12, 2016 | Jun 25, 2030 | U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 21, 2020 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 21, 2022 | ODE-106: For use of UPTRAVI (selexipag) tablets, 200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg for treatment of pulmonary arterial hypertension (PAH, WHO group I) to reduce the risks of disease progression and hospitalization for pah |
ACTELION 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8318802 DP* Epoprostenol formulation and method of making thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 26, 2012; 002: None | Mar 15, 2027 | |
| Pat. No. 8598227 Epoprostenol formulation and method of making thereof Claim Types: Method of use; Process Pat. Sub. Date(s): All strengths: None | Feb 2, 2027 |
ADAMAS PHARMA
GOCOVRI (CAPSULE, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: ADAMAS PHARMA NDA No.: 208944 Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8389578 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Jan 22, 2028 | U-2105: Treatment of dyskinesia in patients with Parkinson's disease receiving immediate release levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8741343 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8796337 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8889740 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 8895614 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 8895615 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8895616 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8895617 Composition and method for treating neurological disease Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 8895618 DP* Composition and method for treating neurological disease Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 21, 2017 | Nov 23, 2025 | |
| Pat. No. 9867791 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 9867792 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 9867793 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 16, 2018 | Dec 2, 2030 | U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 9877933 Method of administering amantadine prior to a sleep period Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 30, 2018 | Dec 2, 2030 | U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Pat. No. 10154971 Methods of administering amantadine Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Dec 18, 2018 | Dec 4, 2034 | U-2459: Treatment of dyskinesia and decreasing off time in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Aug 24, 2020 | I-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 exclusivity | Aug 24, 2024 | ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications |
ADAPT
NARCAN (SPRAY, METERED) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: ADAPT NDA No.: 208411 Prod. No.: 001 RX (4MG/SPRAY)
| Patents | Expiration | Patented 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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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, 2035 | U-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)
| Patents | Expiration | Patented 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, 2035 | U-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, 2035 | U-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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | Dec 21, 2020 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 21, 2024 | ODE-177: To reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crisis |
ADHERA
PRESTALIA (TABLET) (ORAL) AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Drug Classes: 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6696481 DS* DP* Salt of perindopril and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Apr 15, 2023 | U-3: Treatment of hypertension |
| Pat. No. 7846961 DS* DP* .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 29, 2015 | Oct 5, 2029 | U-3: Treatment of hypertension |
ADIENNE SA
TEPADINA (POWDER) (INTRAVENOUS) THIOTEPA
Drug Classes: alkylating drug
NDA Applicant: ADIENNE SA NDA No.: 208264 Prod. No.: 001 RX (15MG/VIAL); 002 RX (100MG/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: I - New Indication | Jan 26, 2020 | I-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 exclusivity | Jan 26, 2024 | ODE-129: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan & cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor cell transplantation for peds. patients with class 3 beta-thalassemia |
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)
| Patents | Expiration | Patented 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, 2020 | U-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, 2019 | U-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, 2027 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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, 2025 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 21, 2019 | ODE-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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Nov 10, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9415043 DS* Combination therapy Claim Types: Compound Pat. Sub. Date(s): 001: Dec 21, 2017 | Mar 14, 2034 | |
| Pat. No. 9931336 DS* DP* Combination therapy Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Apr 11, 2018 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 18, 2022 |
AERIE PHARMS INC
ROCKLATAN (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST; NETARSUDIL DIMESYLATE
Drug Classes: prostaglandin analog; Rho kinase inhibitor
NDA Applicant: AERIE PHARMS INC NDA No.: 208259 Prod. No.: 001 RX (0.005%;EQ 0.02% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Nov 10, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9415043 DS* Combination therapy Claim Types: Compound Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | |
| Pat. No. 9931336 DS* DP* Combination therapy Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9993470 DS* DP* Combination therapy Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Mar 12, 2022 | |
| Exclusivity Code: NCE - New chemical entity | Dec 18, 2022 |
AGIOS PHARMS INC
TIBSOVO (TABLET) (ORAL) IVOSIDENIB
NDA Applicant: AGIOS PHARMS INC NDA No.: 211192 Prod. No.: 001 RX (250MG)
| Patents | Expiration | Patented 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, 2033 | U-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, 2033 | U-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, 2035 | U-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) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 20, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 20, 2025 | ODE-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 exclusivity | May 2, 2026 | ODE-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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7638536 DS* DP* 2-Acylaminothiazole derivative or salt thereof Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jun 15, 2018 | May 5, 2025 | |
| Pat. No. 8338429 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 25, 2019 | Jun 30, 2023 | U-2577: Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment |
| Pat. No. 8765764 2-acylaminothiazole derivative or salt thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 15, 2018 | Jan 15, 2023 | U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET U-2578: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 26, 2022 | I-802: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment |
| Exclusivity Code: NCE - New chemical entity | May 21, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 26, 2026 | ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment |
AKCEA THERAPS
TEGSEDI (SOLUTION) (SUBCUTANEOUS) INOTERSEN SODIUM
NDA Applicant: AKCEA THERAPS NDA No.: 211172 Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7015315 DS* Gapped oligonucleotides Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Mar 21, 2023 | |
| Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Sep 5, 2023 | |
| Pat. No. 8101743 DS* DP* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 1, 2025 | |
| Pat. No. 8697860 DP* Diagnosis and treatment of disease Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9061044 DS* Modulation of transthyretin expression Claim Types: Compound Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | |
| Pat. No. 9399774 Modulation of transthyretin expression Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 1, 2018 | Apr 29, 2031 | U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 5, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 5, 2025 | ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
AKORN
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic; antiarrhythmic
NDA Applicant: AKORN NDA No.: 022221 Prod. No.: 001 RX (3.5%)
| Patents | Expiration | Patented 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, 2026 | U-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)
| Patents | Expiration | Patented 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, 2021 | U-891: Use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye |
ALEXZA PHARMS
ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS NDA No.: 022549 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6716416 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013 | May 20, 2022 | |
| Pat. No. 7052679 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 7078020 DP* Delivery of antipsychotics through an inhalation route Claim Types: Method of use; Kit Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | U-1375: ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults |
| Pat. No. 7090830 DP* Drug condensation aerosols and kits Claim Types: Kit; Formulation; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Aug 18, 2024 | |
| Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 28, 2024 | |
| Pat. No. 7585493 DP* Thin-film drug delivery article and method of use Claim Types: Device; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 7601337 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Product-by-process; Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 8074644 DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013 | Jul 25, 2022 | |
| Pat. No. 8173107 DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 8235037 DP* Drug condensation aerosols and kits Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 26, 2021 | |
| Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 23, 2026 | |
| Pat. No. 8955512 DP* Method of forming an aerosol for inhalation delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 18, 2015 | Oct 26, 2021 | |
| Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Apr 29, 2015 | May 21, 2024 | |
| Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Jul 7, 2016 | May 20, 2024 | |
| Pat. No. 9439907 DP* Method of forming an aerosol for inhalation delivery Claim Types: Device; Process Pat. Sub. Date(s): 001: Oct 13, 2016 | Oct 26, 2021 | |
| Pat. No. 9440034 DP* Drug condensation aerosols and kits Claim Types: Formulation; Kit; Method of administration Pat. Sub. Date(s): 001: Oct 13, 2016 | Oct 26, 2021 | |
| Pat. No. 9687487 DS* DP* Aerosol forming device for use in inhalation therapy Claim Types: Device Pat. Sub. Date(s): 001: Jul 14, 2017 | Oct 26, 2021 |
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)
| Patents | Expiration | Patented 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, 2019 | U-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, 2020 | U-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, 2019 | U-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)
| Patents | Expiration | Patented 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, 2029 | U-1123: Treatment of alcohol dependence U-1124: Prevention of relapse to opioid dependence, following opioid detoxification |
ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 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, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2015 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 9, 2015 | Oct 24, 2033 | U-543: Treatment of schizophrenia |
| Pat. No. 9452131 Aripiprazole formulations having increased injection speeds Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Oct 5, 2016 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds Claim Types: Kit Pat. Sub. Date(s): 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, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Nov 7, 2032 | U-543: Treatment of schizophrenia |
| Pat. No. 10238651 Aripiprazole formulations having increased injection speeds Claim Types: Method of use; Kit Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 19, 2035 | U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound Pat. Sub. Date(s): 001: Jul 18, 2018 | Oct 26, 2030 | |
| Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 18, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Pat. No. 10016415 DP* Aripiprazole prodrug compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 18, 2018 | Sep 8, 2035 | |
| Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Nov 20, 2018 | Jun 24, 2030 | U-543: Treatment of schizophrenia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 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%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 23, 2011 | Nov 24, 2027 *PED | U-1181: A method of treating or preventing ocular pain in a patient |
| Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2012 | Nov 28, 2024 *PED | U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient |
| Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 18, 2013 | Nov 28, 2024 *PED | U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery |
| Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2013 | Nov 28, 2024 *PED | U-1441: A method of treating or reducing ocular pain and burning/stinging |
| Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2014 | May 28, 2024 | |
| Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2015 | May 28, 2024 | U-1626: A method of treating or preventing ocular pain and burning |
| Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 4, 2015 | May 28, 2024 | U-1662: A method of treating ocular pain |
| Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | May 28, 2024 | U-1800: A method of treating ocular pain and/or enhancing ocular comfort |
ALLERGAN
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: cyclooxygenase inhibitor; nonsteroidal anti-inflammatory drug
NDA Applicant: ALLERGAN NDA No.: 022427 Prod. No.: 001 RX (0.45%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010 | Aug 15, 2029 | |
| Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 19, 2013 | Mar 7, 2028 | |
| Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2015 | Aug 5, 2024 | |
| Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015 | Mar 7, 2028 |
ALLERGAN
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021262 Prod. No.: 001 RX (0.15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
ALLERGAN
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: alpha adrenergic agonist
NDA Applicant: ALLERGAN NDA No.: 021770 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 10, 2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 18, 2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 28, 2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 26, 2022 *PED | |
| Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 13, 2014 | Mar 2, 2024 *PED | |
| Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 | Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2017 | Jan 10, 2022 *PED | |
| 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 19, 2022 | U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily |
| Pat. No. 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, 2022 | U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP |
| Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 2, 2012 | Apr 19, 2022 | U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension |
| Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Mar 27, 2013 | Apr 19, 2022 | U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma |
| Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 7, 2014 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2016 | Apr 19, 2022 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 12, 2017 | Apr 19, 2022 | U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid |
| Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 7, 2018 | Apr 19, 2022 | U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid |
ALLERGAN
LASTACAFT (SOLUTION/DROPS) (OPHTHALMIC) ALCAFTADINE
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: ALLERGAN NDA No.: 022134 Prod. No.: 001 RX (0.25%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8664215 Ocular allergy treatments with alcaftadine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2014 | Dec 23, 2027 | U-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%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8038988 DS* DP* Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 31, 2011 | Aug 25, 2023 | U-1208: Treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness |
| Pat. No. 8101161 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012 | May 25, 2024 | U-1217: Method of increasing hair growth U-1218: Method of stimulating hair growth |
| Pat. No. 8263054 Method of enhancing hair growth Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 17, 2012 | Jan 15, 2023 | U-1277: Method of increasing eyelash growth including length, thickness, darkness and/or number of eyelashes by administering bimatoprost to an eyelid margin |
| Pat. No. 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, 2021 | U-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, 2023 | U-1487: Method of increasing eyelash growth |
| Pat. No. 8758733 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 16, 2014 | Jan 15, 2023 | U-1487: Method of increasing eyelash growth |
| Pat. No. 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, 2021 | U-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, 2023 | U-1217: Method of increasing hair growth |
| Pat. No. 9216183 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | Jan 15, 2023 | U-1487: Method of increasing eyelash growth |
| Pat. No. 9226931 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016 | Jan 15, 2023 | U-1799: Method of increasing growth of hair including eyelashes |
| 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, 2021 | U-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%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7851504 DS* DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jun 13, 2027 | |
| Pat. No. 8278353 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2012 | Mar 16, 2025 | |
| Pat. No. 8299118 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2012 | Mar 16, 2025 | U-1295: A method of treating a patient with glaucoma or ocular hypertension |
| Pat. No. 8309605 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2012 | Mar 16, 2025 | U-1293: A method of lowering intraocular pressure in a patient with open angle glaucoma or ocular hypertension U-1294: Method of treating glaucoma in a patient |
| Pat. No. 8338479 DP* Enhanced bimatoprost ophthalmic solution Claim Types: ;Composition; Method of administration Pat. Sub. Date(s): 001: Dec 26, 2012 | Mar 16, 2025 | U-1295: A method of treating a patient with glaucoma or ocular hypertension |
| Pat. No. 8524777 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2013 | Mar 16, 2025 | U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension |
| Pat. No. 8586630 Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: None | Mar 16, 2025 | U-1458: A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension |
| Pat. No. 8772338 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 21, 2014 | Mar 16, 2025 | U-1528: A method of lowering intraocular pressure |
| Pat. No. 8933120 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 10, 2015 | Mar 16, 2025 | |
| Pat. No. 8933127 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 10, 2015 | Mar 16, 2025 | |
| Pat. No. 9155716 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2015 | Mar 16, 2025 | U-1528: A method of lowering intraocular pressure |
| Pat. No. 9241918 DP* Enhanced bimatoprost ophthalmic solution Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 24, 2016 | Mar 16, 2025 | U-1814: Method of treating glaucoma or elevated intraocular pressure |
ALLERGAN
OZURDEX (IMPLANT) (INTRAVITREAL) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: ALLERGAN NDA No.: 022315 Prod. No.: 001 RX (0.7MG)
| Patents | Expiration | Patented 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, 2020 | U-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, 2023 | U-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, 2023 | U-1204: Treatment of uveitis U-1205: Treatment of macular edema |
| Pat. No. 8034370 DP* Ocular implant made by a double extrusion process Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 23, 2011 | Jan 9, 2023 | |
| Pat. No. 8043628 Methods for reducing edema Claim Types: Method of use Pat. Sub. Date(s): 001: None | Oct 20, 2020 | U-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, 2020 | U-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, 2023 | U-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, 2020 | U-1205: Treatment of macular edema |
| Pat. No. 9192511 DP* Ocular implant made by a double extrusion process Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015 | Jan 9, 2023 | |
| Pat. No. 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, 2020 | U-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, 2020 | U-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, 2020 | U-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%)
| Patents | Expiration | Patented 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, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8642556 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 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, 2024 | U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8685930 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 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, 2024 | U-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%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8292129 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 25, 2031 | |
| Pat. No. 8561859 DP* Dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 16, 2032 | |
| Pat. No. 8629111 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 8633162 Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8642556 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 8648048 Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 8685930 DP* Methods of providing therapeutic effects using cyclosporin components Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | |
| Pat. No. 9248191 Methods of providing therapeutic effects using cyclosporin components Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 18, 2016 | Aug 27, 2024 | U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye). |
| Pat. No. 9669974 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | May 11, 2034 | |
| Pat. No. 9676525 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids Claim Types: Device Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 7, 2034 |
ALLERGAN
ZYMAR (SOLUTION/DROPS) (OPHTHALMIC) GATIFLOXACIN
Drug Classes: quinolone antimicrobial
NDA Applicant: ALLERGAN NDA No.: 021493 Prod. No.: 001 RX (0.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6333045 DP* DLR* Aqueous liquid pharmaceutical composition comprised of gatifloxacin Claim Types: Formulation; 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741356 DS* DP* Compounds as opioid receptor modulators Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Jun 26, 2015 | 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, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 8609709 DS* Compounds as opioid receptor modulators Claim Types: Compound; New polymorph, salt, or hydrate Pat. Sub. Date(s): All strengths: Jun 26, 2015 | Mar 14, 2025 | |
| Pat. No. 8691860 DS* Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl Claim Types: New polymorph, salt, or hydrate; Method of use Pat. Sub. Date(s): All strengths: Jun 26, 2015 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 8772325 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 16, 2017 Comments: Method of use | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9115091 DS* DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): All strengths: Sep 23, 2015 | Jul 7, 2028 | U-1738: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline) |
| Pat. No. 9205076 Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 30, 2015 | Mar 14, 2025 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 14, 2016 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). |
| Pat. No. 9675587 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 7, 2017 | Mar 14, 2033 | |
| Pat. No. 9700542 DP* Compounds as opioid receptor modulators Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Aug 7, 2017 | Mar 14, 2025 | |
| Pat. No. 9789125 DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Nov 1, 2017 | Jul 7, 2028 | U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline). U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline) |
| Pat. No. 10188632 DP* Opioid receptor modulator dosage formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 28, 2019 | Mar 14, 2033 | |
| Pat. No. 10213415 DS* Compounds as opioid receptor modulators Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 21, 2019 | Mar 14, 2025 | U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015 | Feb 24, 2022 | U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pnenumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium U-282: Method of treating bacterial infections |
| Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Nov 12, 2026 | |
| Pat. No. 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, 2021 | U-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)
| Patents | Expiration | Patented 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, 2021 | U-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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7803838 DP* Compositions comprising nebivolol Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 5, 2016 | Aug 29, 2026 | |
| Pat. No. 7838552 Compositions comprising nebivolol Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 5, 2016 | Oct 4, 2027 | U-185: Method of treating hypertension |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Jun 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Sep 2, 2019 | M-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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8217083 DP* Mesalamine suppository Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: May 24, 2013 | Jun 6, 2028 | |
| Pat. No. 8436051 DP* Mesalamine suppository Claim Types: Formulation 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6900175 Methods of administering dalbavancin for treatment of bacterial infections Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 13, 2014 | Dec 25, 2023 | U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin. |
| Pat. No. 7115564 DP* Stable pharmaceutical compositions of dalbavancin and methods of administration Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014 | Nov 14, 2023 | |
| Pat. No. 7119061 DP* Dalbavancin compositions for treatment of bacterial infections Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014 | Nov 14, 2023 | |
| Pat. No. 8143212 Dalbavancin compositions for treatment of bacterial infections Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 13, 2014 | Nov 14, 2023 | U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Jan 20, 2019 | D-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 Now | May 23, 2024 | |
| Exclusivity Code: NCE - New chemical entity | May 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43879 Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2013 | Jun 3, 2023 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8481598 Stable dosage forms of levomilnacipran Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Aug 15, 2013 | Mar 2, 2031 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8865937 DS* DP* Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Nov 20, 2014 | May 23, 2032 |
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))
| Patents | Expiration | Patented 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, 2020 | U-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, 2020 | U-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, 2020 | U-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, 2031 | U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin |
| Pat. No. 9259388 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 16, 2016 | Nov 6, 2029 | U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin |
| Pat. No. 10272061 Compositions and methods for unoccluded transdermal oxybutynin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2019 | Apr 26, 2020 | U-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%)
| Patents | Expiration | Patented 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, 2020 | U-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, 2020 | U-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, 2020 | U-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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6916941 DS* DP* Crystalline composition containing escitalopram Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation Pat. Sub. Date(s): All strengths: None | Feb 12, 2023 *PED | |
| Pat. No. 7420069 DP* Crystalline composition containing escitalopram Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Feb 12, 2023 *PED |
ALLERGAN 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 18, 2012 | Jan 28, 2024 | U-1278: Method of treating irritable bowel syndrome with constipation in adults |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
ALLERGAN 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 002: None | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 002: None | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 002: None | Jan 28, 2024 | U-1278: Method of treating irritable bowel syndrome with constipation in adults |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. |
ALLERGAN 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Aug 30, 2026 | U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Product-by-process; Process Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | |
| Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Method of use Pat. Sub. Date(s): 003: Feb 24, 2017 | Jan 28, 2024 | U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Feb 24, 2017 | Feb 17, 2031 | U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Aug 10, 2017 | Aug 16, 2033 | U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Jan 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: None; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Sep 24, 2029 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Dec 5, 2029 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8168209 DP* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | |
| Pat. No. 8173708 Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8283379 Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8329752 DP* Composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | |
| Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | |
| Pat. No. 8338486 Methods for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8362085 Method for administering an NMDA receptor antagonist to a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8580858 Compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | Nov 22, 2025 | U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type |
| Pat. No. 8598233 DP* Method for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016 | May 22, 2026 *PED |
ALLERGAN 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)
| Patents | Expiration | Patented 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, 2020 | U-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, 2020 | U-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, 2020 | U-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, 2020 | U-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, 2020 | U-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, 2020 | U-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)
| Patents | Expiration | Patented 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, 2020 | U-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, 2020 | U-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, 2020 | U-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, 2020 | U-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, 2020 | U-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, 2020 | U-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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6602911 [Extended 435 days (1.2 years)] Methods of treating fibromyalgia Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 14, 2023 | U-882: Management of fibromyalgia (FM) |
| Pat. No. 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, 2021 | U-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, 2021 | U-882: Management of fibromyalgia (FM) |
| Pat. No. 7994220 Milnacipran for the long-term treatment of fibromyalgia syndrome Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None; 004: None | Sep 19, 2029 | U-819: Management of fibromyalgia |
ALLERGAN 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6417175 DS* DP* [Extended 1211 days (3.3 years)] Phosphonocephem derivatives, process for the preparation of the same, and use thereof Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: None | Apr 11, 2022 | U-1676: Methods for treating bacterial infections |
| Pat. No. 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, 2031 | U-282: Method of treating bacterial infections |
| Pat. No. 9629861 DP* Compositions and methods for treating bacterial infections using ceftaroline Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 17, 2017 | Sep 21, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | May 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)
| Patents | Expiration | Patented 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)
| Patents | Expiration | Patented 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, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8193195 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl) butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 14, 2012 | Jun 5, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8236804 Polymorphic forms of 1-'4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl)piperazine hydrochloride Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 14, 2012; 002: None; 003: None | Jun 5, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8673921 DS* DP* Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Mar 21, 2014 | 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47350 Pharmaceutical formulations containing dopamine receptor ligands Claim Types: Method of use Pat. Sub. Date(s): 001: May 15, 2019 | Jul 16, 2029 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine |
| Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): 001: Oct 16, 2015 | Mar 27, 2027 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine |
| Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): 001: Oct 16, 2015 | Dec 16, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 24, 2022 | I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) |
| Exclusivity Code: M - Miscellaneous | Nov 9, 2020 | M-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 entity | Sep 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): 002: Oct 16, 2015 | Mar 27, 2027 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine |
| Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): 002: Oct 16, 2015 | Dec 16, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 24, 2022 | I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) |
| Exclusivity Code: M - Miscellaneous | Nov 9, 2020 | M-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 entity | Sep 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7737142 DS* DP* (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists Claim Types: Compound; Process; Method of use; Composition Pat. Sub. Date(s): All strengths: Oct 16, 2015 | Mar 27, 2027 | U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine U-2543: Treatment of schizophrenia with cariprazine U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine |
| Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Oct 16, 2015 | Dec 16, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | May 24, 2022 | I-798: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) |
| Exclusivity Code: M - Miscellaneous | Nov 9, 2020 | M-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 entity | Sep 17, 2020 |
ALMIRALL
ACZONE (GEL) (TOPICAL) DAPSONE [GENERIC AB]
Drug Classes: sulfone
NDA Applicant: ALMIRALL NDA No.: 207154 Prod. No.: 001 RX (7.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9161926 DP* Topical dapsone and dapsone/adaplene compositions and methods for use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2016 | Nov 18, 2033 | |
| Pat. No. 9517219 Topical dapsone and dapsone/adapalene compositions and methods for use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2016 | Nov 18, 2033 | U-1033: Topical treatment of acne vulgaris |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Feb 24, 2019 |
ALMIRALL
ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: pleuromutilin antibacterial
NDA Applicant: ALMIRALL NDA No.: 022055 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented 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, 2021 | U-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, 2024 | U-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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8318706 DS* DP* Substituted tetracycline compounds Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Oct 12, 2018 | May 1, 2031 | U-2405: A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride |
| Pat. No. 8513223 Substituted tetracycline compounds for treatment of inflammatory skin disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 12, 2018 | Dec 7, 2029 | U-2406: A method for treating a patient 9 years of age and older suffering from an inflammatory skin disorder of non-nodular moderate to severe acne vulgaris comprising administering an effective amount of sarecycline hydrochloride |
| Pat. No. 9255068 DS* DP* Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(met- hyl)amino)-methyl] acid amide and methods of using the same Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 12, 2018 | Feb 9, 2033 | U-2407: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt U-2408: A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt |
| Pat. No. 9481639 Substituted tetracycline compounds for treatment of inflammatory skin disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 12, 2018 | Aug 10, 2028 | U-2409: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering sarecycline hydrochloride in 60 mg, 100 mg or 150 mg equivalent doses |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 1, 2023 |
ALMIRALL
SOLAGE (SOLUTION) (TOPICAL) MEQUINOL; TRETINOIN
Drug Classes: skin lightening agent; retinoid
NDA Applicant: ALMIRALL NDA No.: 020922 Prod. No.: 001 DISC (2%;0.01%)
| Patents | Expiration | Patented 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%)
| Patents | Expiration | Patented 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, 2027 | U-1412: Treatment of atopic dermatitis |
| Pat. No. 8962000 DP* Microemulsion and sub-micron emulsion process and compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 25, 2015 | Aug 31, 2025 | U-1412: Treatment of atopic dermatitis |
| Pat. No. 9492384 DP* Microemulsion and sub-micron emulsion process and compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 19, 2016 | Aug 31, 2025 | U-1412: Treatment of atopic dermatitis |
ALMIRALL
XOLEGEL (GEL) (TOPICAL) KETOCONAZOLE
Drug Classes: azole antifungal
NDA Applicant: ALMIRALL NDA No.: 021946 Prod. No.: 001 RX (2%)
| Patents | Expiration | Patented 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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8058069 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | |
| Pat. No. 8158601 DP* Lipid formulation Claim Types: Compound; Composition; Formulation; Method of administration Pat. Sub. Date(s): 001: Sep 6, 2018 | Nov 10, 2030 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8168775 DS* DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Compound; Composition; Intermediate; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8334373 DS* DP* Nuclease resistant double-stranded ribonucleic acid Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Sep 6, 2018 | May 27, 2025 | |
| Pat. No. 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, 2029 | U-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, 2021 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8802644 DP* Lipid formulation Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 21, 2030 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 8822668 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 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, 2021 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 9234196 DP* Compositions and methods for inhibiting expression of transthyretin Claim Types: Formulation; Intermediate; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Oct 20, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 9364435 DP* Lipid formulations for nucleic acid delivery Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 6, 2018 | Apr 15, 2029 | U-2378: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| Pat. No. 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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 10, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 10, 2025 | ODE-197: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7682633 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jun 19, 2027 | U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed. |
| Pat. No. 7682634 DP* Pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 19, 2027 | |
| Pat. No. 7815934 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 19, 2010; 002: None; 003: None; 004: None; 005: None; 006: None | Dec 12, 2027 | |
| Pat. No. 8158156 Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: None; 004: None; 005: None; 006: None | Jun 19, 2027 | U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed. |
| Pat. No. 8623418 Pharmaceutical composition Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Jan 22, 2015 | Nov 7, 2029 | U-1640: Treatment of moderate to severe chronic pain by administering an intact composition as claimed |
| Pat. No. 8685443 Sequestering subunit and related compositions and methods Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jul 3, 2025 | U-1508: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering a plurality of composite subunits as claimed |
| Pat. No. 8685444 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 3, 2025 | |
| Pat. No. 8846104 DP* Pharmaceutical compositions for the deterrence and/or prevention of abuse Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 28, 2014 | Jun 19, 2027 | |
| Pat. No. 8877247 DP* Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014 | Jun 19, 2027 |
ALVOGEN
FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
Drug Classes: aminoketone
NDA Applicant: ALVOGEN NDA No.: 022497 Prod. No.: 001 RX (450MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7674479 DP* Sustained-release bupropion and bupropion/mecamylamine tablets Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 28, 2011 | Jun 25, 2027 |
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)
| Patents | Expiration | Patented 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, 2023 | U-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, 2023 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 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)
| Patents | Expiration | Patented 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, 2023 | U-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, 2023 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 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)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6348210 Methods for transdermal drug administration Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Nov 10, 2019 | U-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))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 12, 2013 | Feb 5, 2024 | |
| Pat. No. 7754702 DP* Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 12, 2013 | Feb 15, 2028 | U-1432: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron |
| 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, 2027 | U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. |
| 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))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | Apr 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))
| Patents | Expiration | Patented 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, 2036 | U-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))
| Patents | Expiration | Patented 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, 2020 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Feb 2, 2021 | I-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)
| Patents | Expiration | Patented 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, 2028 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Nov 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))
| Patents | Expiration | Patented 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, 2033 | U-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, 2033 | U-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, 2033 | U-2568: Treatment of hypoactive sexual desire disorder (HSDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 21, 2024 |
AMARIN PHARMS
VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL
NDA Applicant: AMARIN PHARMS NDA No.: 202057 Prod. No.: 001 RX (1GM)
| Patents | Expiration | Patented 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, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8293728 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8298554 DP* Stable pharmaceutical composition and methods of using same Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 29, 2030 | |
| Pat. No. 8314086 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8318715 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 29, 2012 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8357677 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8367652 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 7, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8377920 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8399446 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8415335 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 17, 2013 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8426399 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8431560 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8440650 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8445003 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8445013 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8501225 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8518929 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 29, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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)
| Patents | Expiration | Patented 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, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8293728 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8298554 DP* Stable pharmaceutical composition and methods of using same Claim Types: Formulation Pat. Sub. Date(s): 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, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8318715 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8357677 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8367652 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8377920 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8399446 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-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, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8426399 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8440650 Methods of treating hypertriglyceridemia Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2017 | Feb 9, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8445003 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia |
| Pat. No. 8445013 Stable pharmaceutical composition and methods of using same Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 26, 2017 | Apr 29, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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)
| Patents | Expiration | Patented 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, 2026 | U-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 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | May 23, 2020 | M-200: Clinical information added to the use in specific populations section of the labeling. |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 21, 2021 | ODE-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)
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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 *PED | U-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 *PED | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 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))
| Patents | Expiration | Patented 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, 2026 | U-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, 2026 | U-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, 2026 | U-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, 2026 | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 15, 2020 PED | |
| Exclusivity Code: NP - New product | Oct 22, 2022 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 22, 2026 PED | ODE-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)
| Patents | Expiration | Patented 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, 2029 | U-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, 2027 | U-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, 2029 | U-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, 2027 | U-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, 2027 | U-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, 2028 | U-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, 2037 | U-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, 2038 | U-2371: The treatment of Fabry patients |
| Pat. No. 10383864 Methods for treatment of Fabry disease Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 4, 2019 | May 16, 2027 | U-2371: The treatment of Fabry patients |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 10, 2023 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 10, 2025 | ODE-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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Apr 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Mar 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Mar 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Mar 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Mar 20, 2019 |
AMNEAL PHARMS LLC
AMINOCAPROIC ACID (SYRUP) (ORAL) AMINOCAPROIC ACID [GENERIC AA]
Drug Classes: antifibrinolytic
NDA Applicant: AMNEAL PHARMS LLC NDA No.: 212780 Prod. No.: 001 RX (1.25GM/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Feb 26, 2020 |
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)
| Patents | Expiration | Patented 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%)
| Patents | Expiration | Patented 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, 2030 | U-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, 2027 | U-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, 2027 | U-1932: Method of treating mild to moderate atopic dermatitis. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 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%)
| Patents | Expiration | Patented 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 *PED | U-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 *PED | U-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 *PED | U-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 *PED | U-1970: Treatment of onychomychosis of a toenail caused by trichophyton rubrum or trichophyton mentagrophytes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 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**)
| Patents | Expiration | Patented 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, 2021 | U-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**)
| Patents | Expiration | Patented 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, 2027 | U-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)
| Patents | Expiration | Patented 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))
| Patents | Expiration | Patented 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, 2019 | U-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, 2019 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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))
| Patents | Expiration | Patented 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, 2019 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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))
| Patents | Expiration | Patented 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, 2019 | U-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< |