Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as GENERIC have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6100274 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 7, 2020 *PED | |
| Pat. No. 7405223 Treating allergic and inflammatory conditions Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: None | Jan 7, 2020 *PED | U-886: Administering desloratadine to treat the symptoms of perennial allergic rhinitis, seasonal allergic rhinitis, or chronic idiopathic urticaria |
CLARINEX (TABLET, ORALLY DISINTEGRATING) (ORAL) DESLORATADINE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: MERCK SHARP DOHME NDA No.: 021312 Prod. No.: 001 RX (5MG); 002 RX (2.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 7, 2020 *PED | |
| Pat. No. 7618649 DP* Extended release oral dosage composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 19, 2021 *PED | U-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis |
CLARINEX-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: MERCK SHARP DOHME NDA No.: 021313 Prod. No.: 001 RX (2.5MG;120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 7, 2020 *PED | |
| Pat. No. 8187630 DP* Extended release oral dosage composition Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Jun 28, 2012 | Dec 19, 2020 | U-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis |
| Pat. No. 6709676 DP* Extended release oral dosage composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Feb 18, 2021 | U-707: Allergic rhinitis |
| Pat. No. 7618649 DP* Extended release oral dosage composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jun 19, 2021 *PED | U-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis |
CLARINEX D 24 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist; alpha adrenergic agonist
NDA Applicant: MERCK SHARP DOHME NDA No.: 021605 Prod. No.: 001 RX (5MG;240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6100274 DP* 8-chloro-6,11-dihydro-11-](4-piperidylidine)-5H-benzo [5,6]cyclohepta[1,2-bpyridine oral compositions Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 7, 2020 *PED | |
| Pat. No. 7618649 DP* Extended release oral dosage composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jun 19, 2021 *PED | U-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis |
| Pat. No. 6979463 DP* Stable extended release oral dosage composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Mar 28, 2022 | |
| Pat. No. 7820199 DP* Stable extended release oral dosage composition Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 23, 2010 | Sep 28, 2022 *PED |
MICARDIS (TABLET) (ORAL) TELMISARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 020850 Prod. No.: 001 RX (40MG); 003 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 10, 2020 |
MICARDIS (TABLET) (ORAL) TELMISARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 020850 Prod. No.: 002 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jan 10, 2020 | |
| Pat. No. 7998953 Use of inhibitors of the renin-angiotensin system Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 9, 2011 | Jun 6, 2020 | U-1177: Reduction of cardiac tissue damage associated with myocardial infarction |
| Pat. No. 8003679 Use of inhibitors of the renin-angiotensin system Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 9, 2011 | Oct 6, 2022 | U-1176: Treatment or prevention of stroke |
MICARDIS HCT (TABLET) (ORAL) HYDROCHLOROTHIAZIDE; TELMISARTAN [GENERIC AB]
Drug Classes: thiazide diuretic; angiotensin II receptor blocker
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021162 Prod. No.: 001 RX (12.5MG;40MG); 002 RX (12.5MG;80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 10, 2020 |
RUBRACA (TABLET) (ORAL) RUCAPARIB CAMSYLATE
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: CLOVIS ONCOLOGY INC NDA No.: 209115 Prod. No.: 001 RX (EQ 200MG BASE); 002 RX (EQ 300MG BASE); 003 RX (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6495541 DS* DP* Tricyclic inhibitors of poly(ADP-ribose) polymerases Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Jan 10, 2020 | |
| Pat. No. 7351701 Therapeutic compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Jul 23, 2024 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation |
| Pat. No. 7531530 Therapeutic compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Jul 23, 2024 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation |
| Pat. No. 8071579 DNA damage repair inhibitors for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Aug 12, 2027 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation |
| Pat. No. 8143241 DNA damage repair inhibitors for treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Aug 12, 2027 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation |
| Pat. No. 8754072 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[- 5,4,3-cd]indol-6-one Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Feb 10, 2031 | |
| Pat. No. 9045487 DS* DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Feb 10, 2031 | |
| Pat. No. 9861638 Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 6, 2018 | Feb 10, 2031 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation |
| Pat. No. 10278974 DP* Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Jun 4, 2019 | Feb 10, 2031 | |
| Pat. No. 8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 21, 2016; 002: Dec 21, 2016; 003: May 9, 2017 | Aug 4, 2031 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation |
| Pat. No. 9987285 DP* High dosage strength tablets of rucaparib Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 28, 2018 | Aug 17, 2035 | |
| Pat. No. 10130636 High dosage strength tablets of rucaparib Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 17, 2018 | Aug 17, 2035 | U-2012: A method for treating ovarian cancer by administering rucaparib, wherein the cancer is associated with a deleterious BRCA mutation U-2101: Maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy U-2273: A method for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer, wherein the cancer is associated with a deleterious brca mutation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 6, 2021 | I-772: For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy |
| Exclusivity Code: NCE - New chemical entity | Dec 19, 2021 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 19, 2023 | ODE-126: As monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 6, 2025 | ODE-168: For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy |
NEXAVAR (TABLET) (ORAL) SORAFENIB TOSYLATE
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HLTHCARE NDA No.: 021923 Prod. No.: 001 RX (EQ 200MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7235576 DS* DP* Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: None | Jan 12, 2020 | |
| Pat. No. 7351834 DS* [Extended 898 days (2.5 years)] .omega.-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: None | Jan 12, 2020 | |
| Pat. No. 7897623 DP* Omega-carboxyl aryl substituted ureas as P38 kinase inhibitors Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: None | Jan 12, 2020 | |
| Pat. No. 8124630 .omega.-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2013 | Jan 12, 2020 | U-1459: Treatment of carcinoma of the thyroid |
| Pat. No. 8841330 Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: May 15, 2015 | Jan 12, 2020 | U-1696: Treatment of unresectable hepatocellular carcinoma |
| Pat. No. 8618141 Aryl ureas with angiogenesis inhibiting activity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 30, 2014 | Feb 11, 2023 | U-1480: Treatment of advanced renal cell carcinoma |
| Pat. No. 8877933 DS* DP* Thermodynamically stable form of a tosylate salt Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation; Method of use; Product-by-process Pat. Sub. Date(s): 001: Dec 22, 2014 | Dec 24, 2027 | U-1624: Treatment of unresectable hepatocellular carcinoma, advanced renal cell carcinoma, or differentiated thyroid carcinoma. |
| Pat. No. 9737488 DP* Pharmaceutical composition for the treatment of cancer Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 20, 2017 | Sep 10, 2028 | U-1480: Treatment of advanced renal cell carcinoma U-1696: Treatment of unresectable hepatocellular carcinoma U-2107: Treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 22, 2020 | ODE-56: Treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DCT) that is refractory to radioactive iodine treatment. |
TRIESENCE (INJECTABLE) (INTRAVITREAL) TRIAMCINOLONE ACETONIDE
Drug Classes: corticosteroid
NDA Applicant: NOVARTIS NDA No.: 022048 Prod. No.: 001 RX (40MG/ML (40MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6395294 DP* Method of visualization of the vitreous during vitrectomy Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: None | Jan 13, 2020 | U-846: Use for delineation (visualization) during a vitrectomy surgical procedure |
| Pat. No. 8211880 Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection Claim Types: Method of use; Diagnostic or surgical method Pat. Sub. Date(s): 001: Aug 6, 2012 | Mar 10, 2029 | U-1257: Treatment of ophthalmic disorders U-1258: Visualization during vitrectomy procedures |
| Pat. No. 8128960 DP* Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection Claim Types: Formulation Pat. Sub. Date(s): 001: None | Dec 17, 2029 |
BYDUREON (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 001 RX (2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6872700 Methods for glucagon suppression Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jan 14, 2020 | U-2288: Treatment of Type 2 diabetes mellitus with exenatide as an add-on to basil [sic, "basal"] insulin or basal insulin plus metformin therapy U-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4 |
| 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. 6667061 DP* Preparation of injectable suspensions having improved injectability Claim Types: Formulation Pat. Sub. Date(s): 001: None | May 25, 2020 | |
| Pat. No. 6479065 DP* Process for the preparation of polymer-based sustained release compositions Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: None | Aug 10, 2020 | |
| Pat. No. 6414126 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6936590 C-aryl glucoside SGLT2 inhibitors and method Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Oct 4, 2020 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Aug 31, 2021 | |
| Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Oct 9, 2022 | |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 15, 2024 | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 17, 2016 | Apr 15, 2024 | U-412: Treatment of Type 2 diabetes |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Apr 13, 2025 | U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 29, 2013 | Apr 13, 2025 | U-412: Treatment of Type 2 diabetes |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 10, 2013 | Apr 13, 2025 | U-412: Treatment of Type 2 diabetes |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jun 30, 2025 | U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 10, 2013 | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2015 | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus U-2154: Reducing fasting plasma glucose in a human in need thereof using a sustained-release composition containing Exendin-4 U-2155: Reducing body weight in a human in need thereof using a sustained-release composition containing Exendin-4 U-2156: Reducing HBA1C in a human in need thereof using a sustained-release composition containing Exendin-4 |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Jun 20, 2027 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 17, 2017 | Mar 21, 2028 | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | Mar 21, 2028 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 17, 2017 | Mar 21, 2028 | |
| Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 17, 2017 | Aug 19, 2028 | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Nov 17, 2017 | Dec 16, 2029 | |
| Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 17, 2017 | May 26, 2030 | U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 20, 2020 | M-212: Information added to the labeling regarding the safety and efficacy of dapagliflozin in patients with Type 2 diabetes who have inadequate glycemic control on a background combination of metformin and exenatide extended release |
| Exclusivity Code: M - Miscellaneous | Apr 2, 2021 | M-224: Information added to the labeling regarding the safety and efficacy of exenatide extended release as add-on in patients with Type 2 diabetes who have inadequate glycemic control on basal insulin glargine with or without metformin |
BYDUREON BCISE (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 209210 Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6872700 DLR* Methods for glucagon suppression Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Jan 14, 2020 | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2591: Lowering plasma glucagon in adults with Type 2 diabetes mellitus by administering exenatide as an adjunct to diet and exercise |
| Pat. No. 6667061 DP* Preparation of injectable suspensions having improved injectability Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 3, 2017 | May 25, 2020 | |
| Pat. No. 6479065 DP* Process for the preparation of polymer-based sustained release compositions Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Nov 3, 2017 | Aug 10, 2020 | |
| Pat. No. 6414126 C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Oct 4, 2020 | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 6515117 C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Oct 4, 2020 | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 6936590 C-aryl glucoside SGLT2 inhibitors and method Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Oct 4, 2020 | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Oct 4, 2020 | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Nov 3, 2017 | Aug 31, 2021 | |
| Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 9, 2022 | |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 15, 2024 | |
| Pat. No. 9238076 DP* DLR* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 15, 2024 | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less |
| Pat. No. 7612176 DP* DLR* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 13, 2025 | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2592: Improving glycemic control in adults with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise |
| Pat. No. 8431685 DP* DLR* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 13, 2025 | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2598: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an injectable sustained release formulation of exenatide as an adjunct to diet and exercise |
| Pat. No. 8461105 DP* DLR* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Apr 13, 2025 | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2598: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an injectable sustained release formulation of exenatide as an adjunct to diet and exercise |
| Pat. No. 7456254 DP* DLR* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Jun 30, 2025 | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2592: Improving glycemic control in adults with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise |
| Pat. No. 8329648 DLR* Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Aug 18, 2026 | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml |
| Pat. No. 8906851 DLR* Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2017 | Aug 18, 2026 | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin |
| Pat. No. 9884092 DLR* Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2018 | Aug 18, 2026 | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2593: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2594: Reducing fasting plasma glucose in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2595: Reducing body weight in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2596: Reducing HBA1C in adults with Type 2 diabetes mellitus by administering an exenatide formulation once weekly as an adjunct to diet and exercise to achieve a mean steady state plasma concentration of exenatide at least 170 pg/ml U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin |
| Pat. No. 8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Jun 20, 2027 | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 21, 2019 | Mar 21, 2028 | U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin |
| Pat. No. 8895033 DP* DLR* Sustained release formulations using non-aqueous carriers Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Nov 3, 2017 | Oct 4, 2030 | U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin U-2600: Improving glycemic control in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-2601: Stimulating insulin release in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise U-2602: Delaying gastric emptying in adults with Type 2 diabetes mellitus by administering a pre-mixed exenatide formulation as an adjunct to diet and exercise |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Oct 20, 2020 |
BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 022200 Prod. No.: 002 RX (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6872700 Methods for glucagon suppression Claim Types: Method of use Pat. Sub. Date(s): 002: None | Jan 14, 2020 | U-2288: Treatment of Type 2 diabetes mellitus with exenatide as an add-on to basil [sic, "basal"] insulin or basal insulin plus metformin therapy U-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4 |
| 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): 002: Mar 28, 2014 | May 25, 2020 | |
| Pat. No. 6667061 DP* Preparation of injectable suspensions having improved injectability Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 28, 2014 | May 25, 2020 | |
| Pat. No. 6479065 DP* Process for the preparation of polymer-based sustained release compositions Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 002: Mar 28, 2014 | Aug 10, 2020 | |
| Pat. No. 6414126 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6936590 C-aryl glucoside SGLT2 inhibitors and method Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Oct 4, 2020 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Oct 4, 2020 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Mar 28, 2014 | Aug 31, 2021 | |
| Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Mar 28, 2014 | Oct 9, 2022 | |
| Pat. No. 7563871 DP* Polymer-based sustained release device Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 28, 2014 | Apr 15, 2024 | |
| Pat. No. 9238076 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Feb 17, 2016 | Apr 15, 2024 | U-412: Treatment of Type 2 diabetes |
| Pat. No. 7612176 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Apr 13, 2025 | U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide |
| Pat. No. 8431685 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Apr 13, 2025 | U-412: Treatment of Type 2 diabetes |
| Pat. No. 8461105 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Apr 13, 2025 | U-412: Treatment of Type 2 diabetes |
| Pat. No. 7456254 DP* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Jun 30, 2025 | U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide |
| Pat. No. 8329648 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 28, 2014 | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 8906851 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2015 | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus |
| Pat. No. 9884092 Methods for treating diabetes and reducing body weight Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 6, 2018 | Aug 18, 2026 | U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus U-2154: Reducing fasting plasma glucose in a human in need thereof using a sustained-release composition containing Exendin-4 U-2155: Reducing body weight in a human in need thereof using a sustained-release composition containing Exendin-4 U-2156: Reducing HBA1C in a human in need thereof using a sustained-release composition containing Exendin-4 |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Jun 20, 2027 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8758292 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Nov 12, 2027 | |
| Pat. No. 8216180 DP* Administering apparatus with functional drive element Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Jan 12, 2028 | |
| Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 15, 2017 | Mar 21, 2028 | |
| Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | Mar 21, 2028 | U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 15, 2017 | Mar 21, 2028 | |
| Pat. No. 8439864 DP* Device for administering fluid from a multi-chamber ampoule in incremental steps Claim Types: Device Pat. Sub. Date(s): 002: Mar 28, 2014 | Mar 25, 2028 | |
| Pat. No. 9320853 DP* Method for administering a fluid active substance from a multi-chamber ampoule Claim Types: Device; Process Pat. Sub. Date(s): 002: Nov 15, 2017 | Mar 25, 2028 | |
| Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 15, 2017 | Aug 19, 2028 | |
| Pat. No. 8827963 DP* Administering device with holding mechanism Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Feb 4, 2029 | |
| Pat. No. 8690837 DP* Mixing device for a two-chamber ampoule Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | May 19, 2029 | |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 002: Nov 15, 2017 | Dec 16, 2029 | |
| Pat. No. 8998876 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jan 7, 2030 | |
| Pat. No. 8721615 DP* Ampoule comprising an ampoule holder Claim Types: Device Pat. Sub. Date(s): 002: Nov 15, 2017 | Jan 18, 2030 | |
| Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017 | May 26, 2030 | U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Apr 2, 2021 | M-224: Information added to the labeling regarding the safety and efficacy of exenatide extended release as add-on in patients with Type 2 diabetes who have inadequate glycemic control on basal insulin glargine with or without metformin |
BYETTA (INJECTABLE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB NDA No.: 021773 Prod. No.: 001 RX (300MCG/1.2ML (250MCG/ML)); 002 RX (600MCG/2.4ML (250MCG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6872700 Methods for glucagon suppression Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 14, 2020 | U-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4 |
| Pat. No. 6902744 DP* Exendin agonist formulations and methods of administration thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jan 14, 2020 |
GLUCOVANCE (TABLET) (ORAL) GLYBURIDE; METFORMIN HYDROCHLORIDE
Drug Classes: sulfonylurea; biguanide
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 021178 Prod. No.: 001 DISC (1.25MG;250MG**); 002 DISC (2.5MG;500MG**); 003 DISC (5MG;500MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6303146 Solid oral dosage form comprising a combination of metformin and glibenclamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jan 14, 2020 *PED | U-412: Treatment of Type 2 diabetes |
LEXIVA (TABLET) (ORAL) FOSAMPRENAVIR CALCIUM [GENERIC AB]
NDA Applicant: VIIV HLTHCARE NDA No.: 021548 Prod. No.: 001 RX (EQ 700MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6514953 DS* DP* Calcium (3S) tetrahydro-3-furanyl(1S,2R)-3-[[(4-aminophenyl) sulfonyl](isobutyl)amino]-1-benzyl- 2-(phosphonooxy)propylcarbamate Claim Types: New polymorph, salt or hydrate; Process; Method of use; Pat. Sub. Date(s): 001: None | Jan 15, 2020 *PED | U-257: Treatment of HIV infection |
LUZU (CREAM) (TOPICAL) LULICONAZOLE
Drug Classes: azole antifungal
NDA Applicant: MEDICIS NDA No.: 204153 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5900488 DS* DP* [Extended 1291 days (3.5 years)] Method for treating mycosis using imidazolylacetonitrile derivatives Claim Types: Compound; Composition; Process; Method of use Pat. Sub. Date(s): 001: Dec 6, 2013 | Jan 18, 2020 | |
| Pat. No. 9012484 DS* DP* Crystal and pharmaceutical preparation containing the same crystal Claim Types: New polymorph, salt or hydrate; Product-by-process; Method of use; Process Pat. Sub. Date(s): 001: Apr 22, 2015 | Sep 6, 2033 | U-540: Treatment of fungal infections |
| Pat. No. 9199977 DS* DP* Crystal having crystal habits and pharmaceutical composition obtained by processing the crystal Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Feb 5, 2016 | Sep 6, 2033 | |
| Pat. No. 9453006 DS* Crystalline form having specific crystal habit and pharmaceutical composition containing this crystalline form as active ingredient Claim Types: New polymorph, salt or hydrate; Process; Method of use Pat. Sub. Date(s): 001: Sep 29, 2016 | Sep 6, 2033 | |
| Pat. No. 8980931 DP* Method of evaluating pharmaceutical preparation containing luliconazole and index substance Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 23, 2015 | Apr 28, 2034 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Feb 20, 2021 |
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. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Feb 25, 2025 *PED | |
| 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. 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 |
| 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. 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. 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. 8025899 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 11, 2011; 002: None | Jun 14, 2028 *PED |
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. 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 |
| 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 |
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. 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. 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 |
| Pat. No. 8686026 DP* Solid compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015 | Jun 9, 2031 | |
| 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. 8691938 DS* DP* Anti-viral compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 6, 2015 | Apr 13, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 19, 2019 |
BELBUCA (FILM) (BUCCAL) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: partial opioid agonist
NDA Applicant: BDSI NDA No.: 207932 Prod. No.: 001 RX (EQ 0.075MG BASE); 002 RX (EQ 0.15MG BASE); 003 RX (EQ 0.3MG BASE); 004 RX (EQ 0.45MG BASE); 005 RX (EQ 0.6MG BASE); 006 RX (EQ 0.75MG BASE); 007 RX (EQ 0.9MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Nov 20, 2015 | Jan 22, 2020 | U-1769: Treatment of pain by transmucosal delivery of buprenorphine |
| Pat. No. 8147866 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation Pat. Sub. Date(s): All strengths: Nov 20, 2015 | Jul 23, 2027 | U-1769: Treatment of pain by transmucosal delivery of buprenorphine |
| Pat. No. 9655843 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2017 | Jul 23, 2027 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
| Pat. No. 9901539 Transmucosal drug delivery devices for use in chronic pain relief Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 28, 2018 | Dec 21, 2032 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
BUNAVAIL (FILM) (BUCCAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug Classes: partial opioid agonist; opioid antagonist
NDA Applicant: BDSI NDA No.: 205637 Prod. No.: 001 RX (EQ 2.1MG BASE;EQ 0.3MG BASE); 002 RX (EQ 4.2MG BASE;EQ 0.7MG BASE); 003 RX (EQ 6.3MG BASE;EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jun 20, 2014 | Jan 22, 2020 | U-1521: Maintenance treatment of opioid dependence |
| Pat. No. 8147866 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation Pat. Sub. Date(s): All strengths: Jun 20, 2014 | Jul 23, 2027 | U-1521: Maintenance treatment of opioid dependence |
| Pat. No. 9655843 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2017 | Jul 23, 2027 | U-2017: Treatment of opioid dependence |
| Pat. No. 8703177 DP* Abuse-resistant mucoadhesive devices for delivery of buprenorphine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 20, 2014 | Aug 20, 2032 | |
| Pat. No. 9522188 DP* Abuse resistant transmucosal drug delivery device Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 20, 2016 | Apr 24, 2035 |
ONSOLIS (FILM) (BUCCAL) FENTANYL CITRATE
Drug Classes: opioid agonist
NDA Applicant: BDSI NDA No.: 022266 Prod. No.: 001 DISC (EQ 0.2MG BASE); 002 DISC (EQ 0.4MG BASE); 003 DISC (EQ 0.6MG BASE); 004 DISC (EQ 0.8MG BASE); 005 DISC (EQ 1.2MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces Claim Types: Method of administration Pat. Sub. Date(s): All strengths: None | Jan 22, 2020 | U-767: Management of breakthrough pain in patients with cancer |
| Pat. No. 9597288 DP* Transmucosal delivery devices with enhanced uptake Claim Types: Method of administration; Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 3, 2017 | Jul 23, 2027 | U-767: Management of breakthrough pain in patients with cancer |
DALIRESP (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 022522 Prod. No.: 001 RX (500MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5712298 DS* DP* [Extended 5 years] Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: None | Jan 27, 2020 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8431154 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient Claim Types: Product-by-process Pat. Sub. Date(s): 001: None | Feb 19, 2023 | |
| Pat. No. 9468598 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 3, 2016 | Feb 19, 2023 | |
| Pat. No. 8536206 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2013 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8604064 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2014 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8618142 DP* Process for the preparation of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 30, 2014 | Mar 8, 2024 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Jan 23, 2021 | D-171: Revised dosing to include up-titration as a strategy to improve tolerability and thereby reduce treatment discontinuation for roflumilast maintenance dosage of 500 mcg daily |
| Exclusivity Code: M - Miscellaneous | Aug 31, 2020 | M-208: Information added to the labeling to include results of a randomized, double-blind, placebo-controlled study in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
DALIRESP (TABLET) (ORAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 022522 Prod. No.: 002 RX (250MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5712298 DS* DP* [Extended 5 years] Fluoroalkoxy-substituted benzamides and their use as cyclic nucleotide phosphodiesterase inhibitors Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 002: Mar 14, 2018 | Jan 27, 2020 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8431154 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient Claim Types: Product-by-process Pat. Sub. Date(s): 002: Mar 14, 2018 | Feb 19, 2023 | |
| Pat. No. 9468598 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 14, 2018 | Feb 19, 2023 | |
| Pat. No. 8536206 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8604064 Process for the preparation of roflumilast Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 14, 2018 | Mar 8, 2024 | U-1115: Treatment to reduce the risk of copd exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations |
| Pat. No. 8618142 DP* Process for the preparation of roflumilast Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 14, 2018 | Mar 8, 2024 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | Jan 23, 2021 |
ENSTILAR (AEROSOL, FOAM) (TOPICAL) BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Drug Classes: corticosteroid; vitamin D analog
NDA Applicant: LEO PHARMA AS NDA No.: 207589 Prod. No.: 001 RX (0.064%;0.005%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6753013 DP* Pharmaceutical composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 12, 2015 | Jan 27, 2020 | U-1761: Plaque psoriasis U-2627: Topical treatment of plaque psoriasis in patients 12 years and older |
| Pat. No. 9119781 DP* Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 12, 2015 | Dec 10, 2031 *PED | U-1761: Plaque psoriasis U-2627: Topical treatment of plaque psoriasis in patients 12 years and older |
| Pat. No. 10130640 DP* Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 6, 2018 | Dec 10, 2031 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 30, 2023 PED |
TACLONEX (OINTMENT) (TOPICAL) BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE [GENERIC AB]
Drug Classes: corticosteroid; vitamin D analog
NDA Applicant: LEO PHARMA AS NDA No.: 021852 Prod. No.: 001 RX (0.064%;0.005%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6753013 DP* Pharmaceutical composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jan 27, 2020 | U-193: Psoriasis U-88: Treatment of moderate plaque psoriasis |
TACLONEX (SUSPENSION) (TOPICAL) BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Drug Classes: corticosteroid; vitamin D analog
NDA Applicant: LEO PHARMA AS NDA No.: 022185 Prod. No.: 001 RX (0.064%;0.005%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6753013 DP* Pharmaceutical composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jan 27, 2020 | U-1761: Plaque psoriasis U-193: Psoriasis U-88: Treatment of moderate plaque psoriasis |
| Pat. No. 6787529 DP* Topical composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Jan 27, 2020 | U-1761: Plaque psoriasis U-193: Psoriasis U-88: Treatment of moderate plaque psoriasis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jan 25, 2023 PED |
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. 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. 8298554 DP* Stable pharmaceutical composition and methods of using same Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 29, 2030 | |
| 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 |
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. 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. 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. 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 |
WAKIX (TABLET) (ORAL) PITOLISANT HYDROCHLORIDE
NDA Applicant: HARMONY NDA No.: 211150 Prod. No.: 001 RX (EQ 4.45MG BASE); 002 RX (EQ 17.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7169928 DS* DP* Non-imidazole alkylamines as histamine H.sub.3-receptor ligands and their therapeutic applications Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 11, 2019 | Feb 2, 2020 | |
| Pat. No. 7910605 Non-imidazole alkylamines as histamine H.sub.3- receptor ligands and their therapeutic applications Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 11, 2019 | Sep 23, 2022 | U-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy |
| Pat. No. 8354430 Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 11, 2019 | Feb 26, 2026 | U-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy |
| Pat. No. 8207197 DS* DP* Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy] propyl] -piperidine Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Sep 11, 2019 | Feb 25, 2029 | |
| Pat. No. 8486947 Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H.sub.3-receptor ligands Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 11, 2019 | Sep 26, 2029 | U-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 14, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 14, 2026 | ODE-255: Indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy |
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 |
AURYXIA (TABLET) (ORAL) FERRIC CITRATE
Drug Classes: iron replacement product; phosphate binder; decorporation agent
NDA Applicant: KERYX BIOPHARMS NDA No.: 205874 Prod. No.: 001 RX (EQ 210MG IRON)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5753706 DP* Methods for treating renal failure Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 3, 2020 | U-1577: Control of serum phosphorous levels |
| Pat. No. 7767851 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Product-by-process; Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8299298 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8338642 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 8609896 DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8754257 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8754258 DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 | Feb 18, 2024 | |
| Pat. No. 8846976 Ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2014 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 8901349 Ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2015 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9050316 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 9, 2015 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9328133 DS* DP* Ferric organic compounds, uses thereof and methods of making same Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Dec 30, 2016 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9757416 DS* DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 5, 2017 | Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
| Pat. No. 8093423 Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2014 | Apr 21, 2026 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9387191 DP* Ferric citrate dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 9, 2016 | Jul 21, 2030 | |
| Pat. No. 10300039 Ferric citrate dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jul 21, 2030 | U-2549: Control of serum phosphorus levels |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 6, 2020 | I-790: Use of ferric citrate for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis |
ERAXIS (POWDER) (INTRAVENOUS) ANIDULAFUNGIN
Drug Classes: echinocandin antifungal
NDA Applicant: VICURON NDA No.: 021632 Prod. No.: 001 RX (50MG/VIAL); 002 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5965525 DS* DP* [Extended 1223 days (3.4 years)] Cyclic peptide antifungal agents Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: None | Feb 17, 2020 | U-540: Treatment of fungal infections |
| Pat. No. 6960564 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: None | Apr 12, 2021 | U-540: Treatment of fungal infections |
| Pat. No. 7709444 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): All strengths: None | Apr 12, 2021 | U-540: Treatment of fungal infections |
SILENOR (TABLET) (ORAL) DOXEPIN HYDROCHLORIDE
Drug Classes: tricyclic antidepressant (TCA)
NDA Applicant: CURRAX NDA No.: 022036 Prod. No.: 001 RX (EQ 3MG BASE); 002 RX (EQ 6MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6211229 Treatment of transient and short term insomnia Claim Types: Method of administration Pat. Sub. Date(s): All strengths: None | Feb 17, 2020 | U-620: Treatment of insomnia |
| Pat. No. 9486437 Methods of using low-dose doxepin for the improvement of sleep Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Dec 2, 2016 | May 18, 2027 | U-620: Treatment of insomnia |
| Pat. No. 9861607 Methods of using low-dose doxepin for the improvement of sleep Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 24, 2018 | May 18, 2027 | U-620: Treatment of insomnia |
| Pat. No. 10238620 Methods of using low-dose doxepin for the improvement of sleep Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019 | May 18, 2027 | U-620: Treatment of insomnia |
| Pat. No. 9572814 Methods of improving the pharmacokinetics of doxepin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 21, 2017 | Jul 20, 2027 | U-620: Treatment of insomnia |
| Pat. No. 7915307 Methods of improving the pharmacokinetics of doxepin Claim Types: Method of administration Pat. Sub. Date(s): All strengths: None | Aug 24, 2027 | U-620: Treatment of insomnia |
| Pat. No. 9907780 DP* Low-dose doxepin formulations and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 26, 2018 | Apr 11, 2028 | |
| Pat. No. 9107898 Methods of using low-dose doxepin for the improvement of sleep Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 9, 2015 | May 1, 2028 | U-620: Treatment of insomnia |
| Pat. No. 9532971 DP* Low-dose doxepin formulations and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 13, 2017 | Jun 1, 2029 | |
| Pat. No. 8513299 Methods of using low-dose doxepin for the improvement of sleep Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 20, 2013; 002: None | Sep 7, 2030 | U-620: Treatment of insomnia |
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 |
AKYNZEO (CAPSULE) (ORAL) NETUPITANT; PALONOSETRON HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist; serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE NDA No.: 205718 Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6297375 DS* 4-phenyl-pyridine derivatives Claim Types: Compound Pat. Sub. Date(s): 001: Nov 6, 2014 | Feb 22, 2020 | |
| Pat. No. 8623826 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 6, 2014 | Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 8951969 DP* Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 6, 2015 | Nov 18, 2030 | |
| Pat. No. 9186357 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 2, 2015 | Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 9943515 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of use Pat. Sub. Date(s): 001: May 16, 2018 | Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 9271975 Compositions and methods for treating centrally mediated nausea and vomiting Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jul 14, 2016 | Sep 9, 2031 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
| Pat. No. 9951016 DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 16, 2018 | Sep 25, 2035 | |
| Pat. No. 10233154 DS* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Mar 28, 2019 | Sep 25, 2035 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Oct 10, 2019 |
DETROL LA (CAPSULE, EXTENDED RELEASE) (ORAL) TOLTERODINE TARTRATE [GENERIC AB]
Drug Classes: muscarinic antagonist
NDA Applicant: PHARMACIA AND UPJOHN NDA No.: 021228 Prod. No.: 001 RX (2MG); 002 RX (4MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6770295 DP* Therapeutic formulation for administering tolterodine with controlled release Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: None | Feb 26, 2020 *PED | U-544: Treatment of overactive bladder. Treatment of urinary incontinence. |
| Pat. No. 6630162 DP* Pharmaceutical formulation and its use Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): All strengths: None | May 11, 2020 *PED | U-544: Treatment of overactive bladder. Treatment of urinary incontinence. |
| Pat. No. 6911217 DP* Controlled release bead, a method of producing the same and multiple unit formulationcomprising it Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 30, 2013; 002: None | May 11, 2020 *PED | U-544: Treatment of overactive bladder. Treatment of urinary incontinence. |
ONZETRA XSAIL (POWDER) (NASAL) SUMATRIPTAN SUCCINATE
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX NDA No.: 206099 Prod. No.: 001 RX (EQ 11MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6715485 DP* Nasal delivery device Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Mar 3, 2020 | |
| Pat. No. 8555877 DP* Nasal delivery device Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Mar 3, 2020 | |
| Pat. No. 8047202 DP* Nasal devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Jul 2, 2023 | |
| Pat. No. 8327844 Nasal delivery method Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Oct 3, 2023 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 9119932 DP* Nasal delivery device Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: Feb 23, 2016 | Apr 23, 2024 | |
| Pat. No. 7975690 DP* Nasal devices Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Aug 18, 2025 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 8590530 DP* Nasal delivery devices Claim Types: Device; Drug in a container; Method of use Pat. Sub. Date(s): 001: Feb 23, 2016 | Sep 15, 2025 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 9108015 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Sep 15, 2025 | |
| Pat. No. 10124132 DP* Nasal delivery Claim Types: Method of use; Device Pat. Sub. Date(s): 001: Dec 10, 2018 | Mar 6, 2027 | U-1719: Acute treatment of migraine U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity |
| Pat. No. 10398859 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Sep 30, 2019 | Dec 19, 2027 | |
| Pat. No. 8875704 DP* Nasal administration Claim Types: Device; Method of use; Drug in a container Pat. Sub. Date(s): 001: Feb 23, 2016 | Apr 7, 2028 | U-1809: Method of drug delivery via the nasal cavity |
| Pat. No. 10076615 Nasal delivery Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Oct 12, 2018 | Jul 30, 2029 | U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity U-2404: Method of delivering sumatriptan to a nasal cavity |
| Pat. No. 8550073 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Oct 22, 2029 | |
| Pat. No. 8899229 DP* Powder delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Aug 18, 2030 | |
| Pat. No. 9649456 DP* Nasal administration Claim Types: Method of administration; Device Pat. Sub. Date(s): 001: May 26, 2017 | Oct 21, 2030 | U-1719: Acute treatment of migraine U-2010: Acute treatment of migraine by delivering a powdered substance comprising sumatriptan via a breath-powered delivery device U-2011: Treatment of migraine via delivery of sumatriptan via the nasal cavity |
| Pat. No. 8978647 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 23, 2016 | Dec 6, 2030 | |
| Pat. No. 10076614 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Oct 12, 2018 | Oct 20, 2034 |
XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: OPTINOSE US INC NDA No.: 209022 Prod. No.: 001 RX (0.093MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6715485 DP* Nasal delivery device Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Mar 3, 2020 | |
| Pat. No. 8555878 DP* Nasal delivery device Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Mar 20, 2020 | |
| Pat. No. 9468727 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Jul 30, 2020 | |
| Pat. No. 9072857 DP* Nasal delivery device Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Apr 10, 2021 | |
| Pat. No. 8522778 DP* Nasal devices Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | May 11, 2022 | |
| Pat. No. 8327844 Nasal delivery method Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 17, 2017 | Oct 8, 2023 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 7975690 Nasal devices Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 17, 2017 | Dec 29, 2025 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10124132 DP* Nasal delivery Claim Types: Method of use; Device Pat. Sub. Date(s): 001: Dec 6, 2018 | Mar 6, 2027 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10076615 Nasal delivery Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Oct 12, 2018 | Jul 30, 2029 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 8550073 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Oct 22, 2029 | |
| Pat. No. 8978647 DP* Nasal delivery Claim Types: Device Pat. Sub. Date(s): 001: Oct 17, 2017 | Aug 6, 2030 | |
| Pat. No. 10252010 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: May 8, 2019 | Feb 7, 2031 | |
| Pat. No. 10179216 DP* Nasal delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Feb 8, 2019 | Jul 8, 2033 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Pat. No. 10076614 DP* Nasal delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Oct 12, 2018 | Oct 20, 2034 | |
| Pat. No. 10300229 DP* Nasal delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jun 18, 2019 | Jul 7, 2035 | U-2133: Method of delivering fluticasone propionate to a nasal airway |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Sep 18, 2020 |
RENOVA (CREAM) (TOPICAL) TRETINOIN
Drug Classes: retinoid
NDA Applicant: VALEANT PHARMS NORTH NDA No.: 021108 Prod. No.: 001 RX (0.02%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6531141 Oil-in-water emulsion containing tretinoin Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Mar 7, 2020 |
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. 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 | |
| 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 | |
| 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 |
SOMATULINE DEPOT (SOLUTION) (SUBCUTANEOUS) LANREOTIDE ACETATE
Drug Classes: somatostatin analog
NDA Applicant: IPSEN PHARMA NDA No.: 022074 Prod. No.: 001 RX (EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)); 002 RX (EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)); 003 RX (EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5595760 DP* [Extended 5 years] Sustained release of peptides from pharmaceutical compositions Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: None | Mar 8, 2020 | U-831: Method of administering lanreotide acetate |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Sep 15, 2020 | I-754: To reduce the frequency of short-acting somatostatin analog rescue therapy when used for the treatment of adults with carcinoid syndrome |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 15, 2024 | ODE-156: Treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 16, 2021 | ODE-82: Treatment of patients with unresectable,well- or moderately-differentiated locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors to improve progression-free survival |
AFINITOR DISPERZ (TABLET, FOR SUSPENSION) (ORAL) EVEROLIMUS
Drug Classes: kinase inhibitor; mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS PHARM NDA No.: 203985 Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5665772 DS* DP* [Extended 5 years] O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 26, 2012; 002: None; 003: None | Mar 9, 2020 *PED | |
| Pat. No. 7297703 DP* Macrolides Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 26, 2012; 002: None; 003: None | Jun 6, 2020 *PED | |
| Pat. No. 8778962 Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2014 | Aug 18, 2022 *PED | U-1541: Treatment of patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. U-2280: Adjunctive treatment of patients with TSC-associated partial-onset seizures |
| Pat. No. 8617598 DP* Pharmaceutical compositions comprising colloidal silicon dioxide Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Mar 27, 2014 | Mar 27, 2023 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 10, 2021 | I-773: For the adjunctive treatment of adult and pediatric patients age 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 10, 2025 | ODE-169: For the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures |
ZORTRESS (TABLET) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: kinase inhibitor; mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS NDA No.: 021560 Prod. No.: 001 RX (0.25MG); 002 RX (0.5MG); 003 RX (0.75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5665772 DS* DP* [Extended 5 years] O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: None | Mar 9, 2020 *PED | U-1049: Prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a renal transplant U-1365: Prophylaxis of allograft rejection in adult patients receiving a liver transplant |
CYMBALTA (CAPSULE, DELAYED REL PELLETS) (ORAL) DULOXETINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: LILLY NDA No.: 021427 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE); 004 RX (EQ 60MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6596756 Treatment of fibromyalgia Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Mar 10, 2020 *PED | U-882: Management of fibromyalgia (FM) |
TOTECT (INJECTABLE) (INJECTION) DEXRAZOXANE HYDROCHLORIDE [Has competitive generic]
Drug Classes: cytoprotective agent
NDA Applicant: CLINIGEN HLTHCARE NDA No.: 022025 Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6727253 Treatment of accidental extravasation of anthracyclines Claim Types: Method of use Pat. Sub. Date(s): 001: None | Mar 13, 2020 | U-829: Treatment of extravasation resulting from IV anthracycline chemotherapy |
RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: HORIZON PHARMA USA NDA No.: 202020 Prod. No.: 001 RX (1MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6488960 DP* Corticosteroid formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 22, 2012 | Mar 14, 2020 | U-1267: Treatment of rheumatoid arthritis by delayed release formulation of 1mg or 2mg of prednisone |
| Pat. No. 6677326 DP* Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 22, 2012 | Mar 14, 2020 | U-1268: Treatment of pulmonary, gastrointestinal and/or rheumatological diseases or conditions by use of delayed release formulations of 1mg or 2mg prednisone |
| Pat. No. 8309124 Delayed release tablet with defined core geometry Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 13, 2012 | Apr 23, 2024 | U-1292: Treatment of diseases or conditions by the use of a delayed release 1, 2, or 5 mg prednisone tablet |
| Pat. No. 8394407 DP* Delayed release tablet with defined core geometry Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Mar 12, 2013 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9040085 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 25, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9186332 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 7, 2016 | Aug 3, 2027 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: HORIZON PHARMA USA NDA No.: 202020 Prod. No.: 002 RX (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6488960 DP* Corticosteroid formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: None | Mar 14, 2020 | U-1267: Treatment of rheumatoid arthritis by delayed release formulation of 1mg or 2mg of prednisone |
| Pat. No. 6677326 DP* Corticosteroid formulation comprising less than 2.5 mg prednisolone for once daily administration Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: None | Mar 14, 2020 | U-1268: Treatment of pulmonary, gastrointestinal and/or rheumatological diseases or conditions by use of delayed release formulations of 1mg or 2mg prednisone |
| Pat. No. 8309124 Delayed release tablet with defined core geometry Claim Types: Method of administration Pat. Sub. Date(s): 002: None | Apr 23, 2024 | |
| Pat. No. 8394407 DP* Delayed release tablet with defined core geometry Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 002: None | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9040085 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 25, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9186332 Delayed release tablet with defined core geometry Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 4, 2015 | Apr 23, 2024 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
| Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 7, 2016 | Aug 3, 2027 | U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet |
LONSURF (TABLET) (ORAL) TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Drug Classes: thymidine phosphorylase inhibitor; nucleoside analog antiviral; nucleoside metabolic inhibitor
NDA Applicant: TAIHO ONCOLOGY NDA No.: 207981 Prod. No.: 001 RX (EQ 6.14MG BASE;15MG); 002 RX (EQ 8.19MG BASE;20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6479500 Agents for alleviating side effects Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 21, 2015 | Mar 16, 2020 | U-1751: Treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf biological therapy, and if RAS wild-type, an anti-EGFR therapy |
| Pat. No. RE46284 Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Feb 7, 2017 | Dec 16, 2026 | U-1751: Treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf biological therapy, and if RAS wild-type, an anti-EGFR therapy U-2503: Treatment of adults with metastatic gastric or GJA previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropiate, HER2/NEU-targeted therapy |
| Pat. No. 9527833 DS* DP* Stable crystal form of tipiracil hydrochloride and crystallization method for the same Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Jan 27, 2017 | Jun 17, 2034 | |
| Pat. No. 10457666 DS* DP* Stable crystal form of tipiracil hydrochloride and crystallization method for the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Nov 8, 2019 | Jun 17, 2034 | |
| Pat. No. 10456399 Method for treating cancer patients with severe renal impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 8, 2019 | Feb 3, 2037 | U-2642: Method of treating cancer by detecting a creatinine clearance of a patient and administering LONSURF |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Feb 22, 2022 | I-794: Treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy, and if appropriate, HER2/NEU-targeted therapy |
| Exclusivity Code: NCE - New chemical entity | Sep 22, 2020 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 22, 2026 | ODE-229: Treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy, and if appropriate, HER2/NEU-targeted therapy |
KOVANAZE (SPRAY, METERED) (NASAL) OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE
Drug Classes: vasoconstrictor; ester local anesthetic
NDA Applicant: ST RENATUS NDA No.: 208032 Prod. No.: 001 RX (0.1MG/SPRAY;6MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6413499 Methods and kits for maxillary dental anesthesia by means of a nasal deliverable anesthetic Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 20, 2016 | Mar 20, 2020 | U-1876: Method of anesthetizing at least a portion of the maxillary dental arch |
| Pat. No. 8580282 DP* Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration Claim Types: Formulation; Method of use; Device; Method of administration Pat. Sub. Date(s): 001: Jul 20, 2016 | Apr 2, 2030 | U-1876: Method of anesthetizing at least a portion of the maxillary dental arch |
| Pat. No. 9308191 DP* Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Jul 20, 2016 | Apr 2, 2030 | U-1876: Method of anesthetizing at least a portion of the maxillary dental arch |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Jun 29, 2019 |
PREFEST (TABLET) (ORAL) ESTRADIOL; NORGESTIMATE
Drug Classes: estrogen; progestin
NDA Applicant: TEVA WOMENS NDA No.: 021040 Prod. No.: 001 DISC (1MG,1MG;N/A,0.09MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6747019 Low dose estrogen interrupted hormone replacement therapy Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: None | Mar 20, 2020 | U-311: Hormone replacement |
| Pat. No. 7320970 DP* Low dose estrogen interrupted hormone replacement therapy Claim Types: Method of use; Kit Pat. Sub. Date(s): 001: None | Mar 30, 2020 | U-844: PREFEST is indicated in women who have a uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021343 Prod. No.: 001 RX (7.5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process Pat. Sub. Date(s): 001: None | Mar 27, 2020 |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021379 Prod. No.: 001 RX (22.5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process Pat. Sub. Date(s): 001: None | Mar 27, 2020 | |
| Pat. No. 8840916 DP* Sustained release polymer Claim Types: Compound Pat. Sub. Date(s): 001: Jan 31, 2017 | Nov 13, 2020 | |
| Pat. No. 9539333 DS* DP* Sustained release polymer Claim Types: Intermediate; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 31, 2017 | Nov 13, 2020 | U-621: Method of treating cancer |
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 31, 2017 | Oct 15, 2023 | U-621: Method of treating cancer |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021488 Prod. No.: 001 RX (30MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process Pat. Sub. Date(s): 001: None | Mar 27, 2020 | |
| Pat. No. 8840916 DP* Sustained release polymer Claim Types: Compound Pat. Sub. Date(s): 001: Jan 31, 2017 | Nov 13, 2020 | |
| Pat. No. 9539333 DS* DP* Sustained release polymer Claim Types: Intermediate; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 30, 2017 | Nov 13, 2020 | U-621: Method of treating cancer |
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 31, 2017 | Oct 15, 2023 | U-621: Method of treating cancer |
ELIGARD (INJECTABLE) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR THERAP NDA No.: 021731 Prod. No.: 001 RX (45MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6626870 DP* Stoppering method to maintain sterility Claim Types: Device; Process Pat. Sub. Date(s): 001: None | Mar 27, 2020 | |
| Pat. No. 8840916 DP* Sustained release polymer Claim Types: Compound Pat. Sub. Date(s): 001: Jan 31, 2017 | Nov 13, 2020 | |
| Pat. No. 9539333 DS* DP* Sustained release polymer Claim Types: Intermediate; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 31, 2017 | Nov 13, 2020 | U-621: Method of treating cancer |
| Pat. No. 9914802 DS* DP* Sustained release polymer Claim Types: Method of use; Process; Formulation Pat. Sub. Date(s): 001: Mar 14, 2018 | Nov 13, 2020 | U-1666: Palliative treatment of prostate cancer |
| Pat. No. 8470359 DS* DP* Sustained release polymer Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 31, 2017 | Oct 15, 2023 | U-621: Method of treating cancer |
TAYTULLA (CAPSULE) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: estrogen; progestin
NDA Applicant: APIL NDA No.: 204426 Prod. No.: 001 RX (0.02MG;1MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6652880 DP* Oral pharmaceutical compositions containing long-chain triglycerides and liphophilic surfactants Claim Types: Formulation Pat. Sub. Date(s): 001: None | Mar 29, 2020 |
MOXEZA (SOLUTION/DROPS) (OPHTHALMIC) MOXIFLOXACIN HYDROCHLORIDE [GENERIC AT2]
Drug Classes: quinolone antimicrobial
NDA Applicant: NOVARTIS NDA No.: 022428 Prod. No.: 001 RX (EQ 0.5% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6716830 DP* Ophthalmic antibiotic compositions containing moxifloxacin Claim Types: Composition Pat. Sub. Date(s): 001: None | Mar 29, 2020 *PED | |
| Pat. No. 7671070 DP* Method of treating ophthalmic infections with moxifloxacin compositions Claim Types: Method of use Pat. Sub. Date(s): 001: None | Mar 29, 2020 *PED | U-709: Method of combating bacteria in a patient |
| Pat. No. 8450311 DP* Pharmaceutical compositions containing a fluoroquinolone antibiotic drug Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 10, 2013 | May 29, 2029 | |
| Pat. No. 9114168 DP* Pharmaceutical compositions containing a fluoroquinolone antibiotic drug Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 8, 2015 | May 29, 2029 |
VIGAMOX (SOLUTION/DROPS) (OPHTHALMIC) MOXIFLOXACIN HYDROCHLORIDE [GENERIC AT1]
Drug Classes: quinolone antimicrobial
NDA Applicant: NOVARTIS NDA No.: 021598 Prod. No.: 001 RX (EQ 0.5% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6716830 DP* Ophthalmic antibiotic compositions containing moxifloxacin Claim Types: Composition Pat. Sub. Date(s): 001: None | Mar 29, 2020 *PED | |
| Pat. No. 7671070 Method of treating ophthalmic infections with moxifloxacin compositions Claim Types: Method of use Pat. Sub. Date(s): 001: None | Mar 29, 2020 *PED | U-709: Method of combating bacteria in a patient |
LEVO-T (TABLET) (ORAL) LEVOTHYROXINE SODIUM [GENERIC AB1,AB2,AB3]
Drug Classes: L-thyroxine (T4)
NDA Applicant: CEDIPROF INC NDA No.: 021342 Prod. No.: 001 RX (0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 002 RX (0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 003 RX (0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 004 RX (0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 005 RX (0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 006 RX (0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 007 RX (0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 008 RX (0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 009 RX (0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 010 RX (0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium); 011 RX (0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6399101 Stable thyroid hormone preparations and method of making same Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Mar 30, 2020 |
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. 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 |
| Pat. No. 7247316 DP* Compositions and methods for treating lymphoma Claim Types: Kit Pat. Sub. Date(s): 001: Sep 6, 2012 | Sep 25, 2020 | |
| 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 |
AUGMENTIN XR (TABLET, EXTENDED RELEASE) (ORAL) AMOXICILLIN; CLAVULANATE POTASSIUM [GENERIC AB]
Drug Classes: penicillin class antibacterial
NDA Applicant: NEOPHARMA NDA No.: 050785 Prod. No.: 001 RX (1GM;EQ 62.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6746692 DP* Modified release pharmaceutical formulation comprising amoxycillin Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 4, 2020 | |
| Pat. No. 6783773 DP* Composition comprising amoxicillin and potassium clavulanate Claim Types: Formulation Pat. Sub. Date(s): 001: None | Apr 4, 2020 | |
| Pat. No. 6878386 Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 4, 2020 | U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml) |
| Pat. No. 7217430 DP* Compositions and methods of treatment comprising amoxicillin and potassium clavulanate with xanthan Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None | Apr 4, 2020 | U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml) |
| Pat. No. 7250176 Method of treating a bacterial infection Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 4, 2020 | U-926: Mgt specific bacterial infections. treatment pts w/ community acquired pneumonia or bacterial sinusitis due to confirmed, or suspected b-lactamase producing pathogens & S. pneumoniae with reduced susceptibility to penicillin (mic=2mc/ml) |
XEPI (CREAM) (TOPICAL) OZENOXACIN
Drug Classes: quinolone antimicrobial
NDA Applicant: FERRER INTERNACIONAL NDA No.: 208945 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6335447 DS* Quinolonecarboxylic acid derivatives or salts thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jan 19, 2018 | Apr 6, 2020 | |
| Pat. No. 9399014 Pharmaceutical topical compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2018 | Dec 15, 2029 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
| Pat. No. 9180200 DP* Pharmaceutical topical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 19, 2018 | Jan 29, 2032 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 11, 2022 |
QBREXZA (CLOTH) (TOPICAL) GLYCOPYRRONIUM TOSYLATE
Drug Classes: anticholinergic
NDA Applicant: DERMIRA INC NDA No.: 210361 Prod. No.: 001 RX (EQ 2.4% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6433003 Method for treating hyperhidrosis in mammals Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 20, 2018 | Apr 10, 2020 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 10052267 DP* Topical glycopyrrolate formulations Claim Types: Formulation; Device; Method of use Pat. Sub. Date(s): 001: Sep 20, 2018 | Oct 17, 2028 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 8618160 DP* Topical glycopyrrolate formulations Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Sep 20, 2018 | Dec 10, 2029 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 9744105 DP* Topical glycopyrrolate formulations Claim Types: Formulation; Device; Method of use Pat. Sub. Date(s): 001: Sep 20, 2018 | Jul 18, 2030 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 8859610 DP* Crystalline glycopyrrolate tosylate Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Sep 20, 2018 | Feb 28, 2033 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 9259414 Glycopyrrolate salts Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 20, 2018 | Feb 28, 2033 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 10004717 DP* Glycopyrrolate salts Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): 001: Sep 20, 2018 | Feb 28, 2033 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
ZOLOFT (CONCENTRATE) (ORAL) SERTRALINE HYDROCHLORIDE [GENERIC AA]
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: PFIZER NDA No.: 020990 Prod. No.: 001 RX (EQ 20MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6727283 DP* Sertraline oral concentrate Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | Apr 11, 2020 *PED | U-580: Treatment of disorders of the serotonergic system such as depression and anxiety-related disorders |
| Pat. No. 7067555 DP* Sertraline oral concentrate Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None | Apr 11, 2020 *PED |
ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9358207 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Apr 12, 2020 | |
| Pat. No. 8518421 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 26, 2013 | Jul 24, 2021 *PED | |
| Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 9089567 Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 | Jan 28, 2022 | U-543: Treatment of schizophrenia |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 004 DISC (20MG**); 005 DISC (30MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9358207 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Apr 12, 2020 | |
| Pat. No. 8518421 DP* Flashmelt oral dosage formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 26, 2013 | Jul 24, 2021 *PED | |
| Pat. No. 7053092 5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8642600 Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
| Pat. No. 9359302 DS* DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
| Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Mar 25, 2023 *PED | |
| Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 | Mar 25, 2023 *PED | |
| Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 | Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None | Dec 16, 2024 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ULTRAM (TABLET) (ORAL) TRAMADOL HYDROCHLORIDE [Has competitive generic]
Drug Classes: opioid agonist
NDA Applicant: JANSSEN PHARMS NDA No.: 020281 Prod. No.: 002 RX (50MG) NDA No.: 020281 Prod. No.: 001 DISC (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6339105 Analgesic regimen Claim Types: Method of administration Pat. Sub. Date(s): All strengths: None | Apr 12, 2020 *PED | U-435: A titration dosing regimen for the treatment of pain using an initial dose of about 25mg |
DELZICOL (CAPSULE, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: APIL NDA No.: 204412 Prod. No.: 001 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6649180 DP* Hard capsule formed of cellulose ether film with a specific content of methoxyl and hydroxypropoxyl groups Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 12, 2013 | Apr 13, 2020 |
SAFYRAL (TABLET) (ORAL) DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM [GENERIC AB]
Drug Classes: progestin; estrogen
NDA Applicant: BAYER HLTHCARE NDA No.: 022574 Prod. No.: 001 RX (3MG,N/A;0.03MG,N/A;0.451MG,0.451MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6441168 DS* [Extended 834 days (2.3 years)] Stable crystalline salts of 5-methyltetrahydrofolic acid Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: None | Apr 17, 2020 | |
| Pat. No. 6958326 DP* Cyclodextrin-drospirenone inclusion complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None | Dec 20, 2021 | |
| Pat. No. 7163931 Compositions of estrogen-cyclodextrin complexes Claim Types: Method of use Pat. Sub. Date(s): 001: None | Mar 3, 2022 | U-1: Prevention of pregnancy |
| Pat. No. 8617597 DP* Pharmaceutical composition containing a tetrahydrofolic acid Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 29, 2014 | Feb 8, 2030 |
VIAGRA (TABLET) (ORAL) SILDENAFIL CITRATE [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: PFIZER INC NDA No.: 020895 Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 50MG BASE); 003 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6469012 Pyrazolopyrimidinones for the treatment of impotence Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Apr 22, 2020 *PED | U-155: Treatment of erectile dysfunction |
GELNIQUE (GEL) (TRANSDERMAL) OXYBUTYNIN CHLORIDE [GENERIC AB]
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN 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. 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 |
| Pat. No. 9259388 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 16, 2016 | Nov 6, 2029 | U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin |
| Pat. No. 10449173 DP* Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 30, 2019 | Nov 6, 2029 | U-2637: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence with a single unit dose of 10% oxybutynin chloride gel |
| 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 |
GELNIQUE 3% (GEL, METERED) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN 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. 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 |
| Pat. No. 7198801 DP* Formulations for transdermal or transmucosal application Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 27, 2012 | Jun 25, 2022 |
OXYTROL (FILM, EXTENDED RELEASE) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN 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 |
OXYTROL FOR WOMEN (FILM, EXTENDED RELEASE) (TRANSDERMAL) OXYBUTYNIN
Drug Classes: muscarinic antagonist
NDA Applicant: ALLERGAN 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 |
MINIVELLE (FILM, EXTENDED RELEASE) (TRANSDERMAL) ESTRADIOL [GENERIC AB3]
Drug Classes: estrogen
NDA Applicant: NOVEN NDA No.: 203752 Prod. No.: 001 RX (0.0375MG/24HR); 002 RX (0.075MG/24HR); 003 RX (0.05MG/24HR); 004 RX (0.1MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6841716 DP* Patch Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 27, 2012; 002: None; 003: None; 004: None | Apr 27, 2020 | |
| Pat. No. 9730900 Transdermal estrogen device and delivery Claim Types: Method of administration; Process Pat. Sub. Date(s): All strengths: Aug 18, 2017 | Jul 10, 2028 | U-2086: A method for administering estradiol comprising a monolithic transdermal drug delivery system consisting of (i) a backing layer and (ii) a single adhesive polymer matrix layer as claimed in US Patent No. 9730900 |
| Pat. No. 9833419 DP* Transdermal estrogen device and delivery Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 14, 2017 | Jul 10, 2028 | |
| Pat. No. 8231906 DS* DP* Transdermal estrogen device and delivery Claim Types: Formulation; Method of administration; Process Pat. Sub. Date(s): 001: Mar 22, 2013; 002: None; 003: None; 004: None | Jul 4, 2030 |
MINIVELLE (FILM, EXTENDED RELEASE) (TRANSDERMAL) ESTRADIOL [GENERIC AB3]
Drug Classes: estrogen
NDA Applicant: NOVEN NDA No.: 203752 Prod. No.: 005 RX (0.025MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6841716 DP* Patch Claim Types: Formulation Pat. Sub. Date(s): 005: May 8, 2015 | Apr 27, 2020 | |
| Pat. No. 9724310 DS* DP* Transdermal estrogen device and delivery Claim Types: Formulation Pat. Sub. Date(s): 005: Aug 18, 2017 | Jul 10, 2028 | |
| Pat. No. 9730900 DP* Transdermal estrogen device and delivery Claim Types: Method of administration; Process Pat. Sub. Date(s): 005: Aug 18, 2017 | Jul 10, 2028 | U-2086: A method for administering estradiol comprising a monolithic transdermal drug delivery system consisting of (i) a backing layer and (ii) a single adhesive polymer matrix layer as claimed in US Patent No. 9730900 |
| Pat. No. 9833419 DP* Transdermal estrogen device and delivery Claim Types: Formulation Pat. Sub. Date(s): 005: Dec 14, 2017 | Jul 10, 2028 | |
| Pat. No. 8231906 DS* DP* Transdermal estrogen device and delivery Claim Types: Formulation; Method of administration; Process Pat. Sub. Date(s): 005: May 8, 2015 | Jul 4, 2030 |
MUCINEX (TABLET, EXTENDED RELEASE) (ORAL) GUAIFENESIN [GENERIC OTC]
NDA Applicant: RB HLTH NDA No.: 021282 Prod. No.: 001 OTC (600MG); 002 OTC (1.2GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6372252 Guaifenesin sustained release formulation and tablets Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 28, 2020 | U-489: Expectorant |
| Pat. No. 6955821 DP* Sustained release formulations of guaifenesin and additional drug ingredients Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Apr 28, 2020 | U-489: Expectorant |
| Pat. No. 7838032 DP* Sustained release of guaifenesin Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2010; 002: None | Apr 28, 2020 |
MUCINEX D (TABLET, EXTENDED RELEASE) (ORAL) GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: alpha adrenergic agonist
NDA Applicant: RB HLTH NDA No.: 021585 Prod. No.: 001 OTC (600MG;60MG); 002 OTC (1.2GM;120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6372252 DP* Guaifenesin sustained release formulation and tablets Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 28, 2020 | |
| Pat. No. 6955821 DP* Sustained release formulations of guaifenesin and additional drug ingredients Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Apr 28, 2020 | U-686: Expectorant and nasal decongestant |
| Pat. No. 7838032 DP* Sustained release of guaifenesin Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2010; 002: None | Apr 28, 2020 |
MUCINEX DM (TABLET, EXTENDED RELEASE) (ORAL) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN [GENERIC OTC]
Drug Classes: sigma-1 agonist; uncompetitive NMDA receptor antagonist
NDA Applicant: RB HLTH NDA No.: 021620 Prod. No.: 001 OTC (60MG;1.2GM); 002 OTC (30MG;600MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6372252 DP* Guaifenesin sustained release formulation and tablets Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Apr 28, 2020 | |
| Pat. No. 6955821 DP* Sustained release formulations of guaifenesin and additional drug ingredients Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Apr 28, 2020 | U-685: Expectorant and cough suppressant |
| Pat. No. 7838032 DP* Sustained release of guaifenesin Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2010; 002: None | Apr 28, 2020 |
NEXIUM (FOR SUSPENSION, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 021957 Prod. No.: 001 RX (EQ 20MG BASE/PACKET); 002 RX (EQ 40MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: None | May 3, 2020 *PED | U-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis U-729: Treatment of gastroesophageal reflux disease (GERD), risk-reduction of NSAID-associated gastric ulcer, H.pylori eradication to reduce the risk of duodenal ulcer recurrence U-773: Pathological hypersecretory conditions |
NEXIUM (FOR SUSPENSION, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 021957 Prod. No.: 003 RX (EQ 2.5MG BASE/PACKET); 004 RX (EQ 5MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 003: Jan 12, 2012; 004: None | May 3, 2020 *PED | U-1207: Infant use aged 1 month to less than one year, GERD and erosive esophagitis |
NEXIUM (FOR SUSPENSION, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 022101 Prod. No.: 001 RX (EQ 10MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | May 3, 2020 *PED | U-858: Pediatric use aged 1-11 years, GERD and erosive esophagitis |
NEXIUM 24HR (CAPSULE, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM [GENERIC OTC]
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA LP NDA No.: 204655 Prod. No.: 001 OTC (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Apr 24, 2014 | May 3, 2020 *PED | U-1509: Treatment of frequent heartburn by administering a gastric acid reducer U-1874: Treatment of frequent heartburn by administering omeprazole according to claims 1-8 |
NEXIUM 24HR (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM
Drug Classes: proton pump inhibitor
NDA Applicant: ASTRAZENECA LP NDA No.: 207920 Prod. No.: 001 OTC (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6428810 DP* Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Dec 18, 2015 | May 3, 2020 *PED | U-1785: Method of treating frequent heartburn by administering an esomeprazole magnesium formulation as claimed |
ABLAVAR (SOLUTION) (INTRAVENOUS) GADOFOSVESET TRISODIUM
Drug Classes: paramagnetic contrast agent
NDA Applicant: LANTHEUS MEDCL NDA No.: 021711 Prod. No.: 001 DISC (2440MG/10ML (244MG/ML)); 002 DISC (3660MG/15ML (244MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6676929 DP* [Extended 1805 days (4.9 years)] Diagnostic imaging contrast agents with extended blood retention Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: None | May 4, 2020 |
INSPRA (TABLET) (ORAL) EPLERENONE [GENERIC AB]
Drug Classes: aldosterone antagonist
NDA Applicant: SEARLE, GD LLC NDA No.: 021437 Prod. No.: 001 RX (25MG); 002 RX (50MG) NDA No.: 021437 Prod. No.: 003 DISC (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6410524 Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: None | May 5, 2020 *PED | U-467: Use of eplerenone in combination with an angiotensin converting enzyme (ACE) inhibitor for treating hypertension |
| Pat. No. 6747020 Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 5, 2020 *PED | U-587: Use of eplerenone in combination with an angiotensin converting enzyme (ACE) inhibitor (and optionally a diuretic) for treating congestive heart failure and hypertension |
| Pat. No. 6410054 Immediate release eplerenone compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-3: Treatment of hypertension U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone |
| Pat. No. 6495165 Eplerenone compositions having improved bioavailability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-3: Treatment of hypertension U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone |
| Pat. No. 6534093 Immediate release eplerenone compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-3: Treatment of hypertension U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone |
| Pat. No. 6558707 DP* Immediate release eplerenone compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-537: Treatment of conditions related to hyperaldosteronism such as hypertension and cardiac insufficiency, with eplerenone |
| Pat. No. 7157101 DP* Micronized eplerenone compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 8, 2020 *PED | U-664: Treatment of conditions for which an aldosterone receptor blocker is indicated, such as hypertension, heart failure, and post-myocardial infarction |
LUVOX CR (CAPSULE, EXTENDED RELEASE) (ORAL) FLUVOXAMINE MALEATE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: JAZZ PHARMS NDA No.: 022033 Prod. No.: 001 DISC (100MG**); 002 DISC (150MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7465462 DP* Multiparticulate controlled release selective serotonin reuptake inhibitor formulations Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | May 10, 2020 | U-929: Treatment of obsessive compulsive disorder treatable with an ssri |
TOBI PODHALER (POWDER) (INHALATION) TOBRAMYCIN
Drug Classes: aminoglycoside antibacterial
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 201688 Prod. No.: 001 RX (28MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7442388 DP* Phospholipid-based powders for drug delivery Claim Types: Formulation; Method of administration; Process Pat. Sub. Date(s): 001: Apr 19, 2013 | May 10, 2020 | |
| Pat. No. 8349294 DP* Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 19, 2013 | May 10, 2020 | |
| Pat. No. 7368102 DP* Pulmonary delivery of aminoglycosides Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Dec 19, 2022 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 8715623 DP* Pulmonary delivery of aminoglycoside Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: Oct 20, 2014 | Dec 19, 2022 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 9421166 DP* Pulmonary delivery of aminoglycoside Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Jun 17, 2019 | Dec 19, 2022 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 7516741 DP* Aerosolization apparatus with feedback mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Apr 19, 2013 | Jan 11, 2024 | |
| Pat. No. 8069851 DP* Aeorosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Apr 19, 2013 | Sep 24, 2024 | |
| Pat. No. 8664187 Methods of treatment of endobronchial infections Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 001: Jun 17, 2019 | Jun 20, 2025 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 7559325 DP* Aerosolization apparatus with air inlet shield Claim Types: Device Pat. Sub. Date(s): 001: Apr 19, 2013 | Oct 27, 2025 | |
| Pat. No. 8869794 DP* Aerosolization apparatus with capsule puncturing member Claim Types: Device; Process; Part of a dosage form Pat. Sub. Date(s): 001: Jun 17, 2019 | Sep 12, 2028 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
| Pat. No. 10207066 DP* Aerosolization apparatus with capsule puncture alignment guide Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jun 17, 2019 | Nov 4, 2030 | U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa |
LYMPHOSEEK KIT (INJECTABLE) (INJECTION) TECHNETIUM TC-99M TILMANOCEPT
NDA Applicant: CARDINAL HEALTH 414 NDA No.: 202207 Prod. No.: 001 RX (N/A)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6409990 DS* Macromolecular carrier for drug and diagnostic agent delivery Claim Types: Compound; Process; Formulation Pat. Sub. Date(s): 001: None | May 12, 2020 | |
| Pat. No. 9439985 DS* DP* Compositions for radiolabeling diethylenetriaminepentaacetic acid (DTPA)-dextran Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 14, 2016 | Sep 27, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 13, 2021 | ODE-67: Guiding sentinel lymph node biopsy, using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity |
EPANOVA (CAPSULE) (ORAL) OMEGA-3-CARBOXYLIC ACIDS
Drug Classes: omega-3 fatty acid
NDA Applicant: ASTRAZENECA PHARMS NDA No.: 205060 Prod. No.: 001 DISC (1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5792795 DP* Treatment of inflammatory bowel disease using oral dosage forms of omega-3 polyunsaturated acids Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 3, 2014 | May 13, 2020 | |
| Pat. No. 5948818 DP* Treatment of inflammatory bowel disease using oral dosage forms of omega-3 polyunsaturated acids Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 3, 2014 | May 13, 2020 | |
| Pat. No. 7960370 DP* Type A gelatin capsule containing PUFA in free acid form Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 3, 2014 | Feb 7, 2025 | |
| Pat. No. 8383678 DP* Type a gelatin capsule containing PUFA in free acid form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 3, 2014 | Feb 7, 2025 | U-1511: Treatment of hypertriglyceridemia |
| Pat. No. 9012501 DP* Type A gelatin capsule containing PUFA in free acid form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 20, 2015 | Feb 7, 2025 | U-1511: Treatment of hypertriglyceridemia |
| Pat. No. 9132112 DP* Type A gelatin capsule containing PUFA in free acid form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 30, 2015 | Feb 7, 2025 | U-1511: Treatment of hypertriglyceridemia |
| Pat. No. 9050308 DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form Claim Types: Method of treatment Pat. Sub. Date(s): 001: Jul 7, 2015 | Jan 4, 2033 | U-1511: Treatment of hypertriglyceridemia |
| Pat. No. 9050309 DS* DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 7, 2015 | Jan 4, 2033 | |
| Pat. No. 10117844 DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2018 | Jan 4, 2033 | U-2447: Treatment of severe hypertriglyceridemia (500 mg/dl) in adult patients as an adjunct to diet |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 5, 2019 |
DEPO-SUBQ PROVERA 104 (INJECTABLE) (SUBCUTANEOUS) MEDROXYPROGESTERONE ACETATE
Drug Classes: progestin
NDA Applicant: PHARMACIA AND UPJOHN NDA No.: 021583 Prod. No.: 001 RX (104MG/0.65ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6495534 DP* Stabilized aqueous suspensions for parenteral use Claim Types: Composition; Process; Formulation Pat. Sub. Date(s): 001: None | May 15, 2020 |
FORTOVASE (CAPSULE) (ORAL) SAQUINAVIR
Drug Classes: HIV protease inhibitor
NDA Applicant: HOFFMANN LA ROCHE NDA No.: 020828 Prod. No.: 001 DISC (200MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6352717 Process for encapsulating shear sensitive fill masses into capsules and capsules containing shear sensitive fill masses Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: None | May 16, 2020 *PED |
JYNARQUE (TABLET) (ORAL) TOLVAPTAN
Drug Classes: vasopressin V2-receptor antagonist
NDA Applicant: OTSUKA PHARM CO LTD NDA No.: 204441 Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG); 004 RX (60MG); 005 RX (90MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5753677 [Extended 5 years] Benzoheterocyclic compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 21, 2018 | May 19, 2020 | U-2307: Treatment of autosomal dominant polycystic kidney disease |
| Pat. No. 8501730 DS* Process for preparing benzazepine compounds or salts thereof Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: May 21, 2018 | Sep 1, 2026 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 23, 2021 | I-779: Use of tolvaptan to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 23, 2025 | ODE-178: Indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) |
SAMSCA (TABLET) (ORAL) TOLVAPTAN
Drug Classes: vasopressin V2-receptor antagonist
NDA Applicant: OTSUKA AMERICA PHARM NDA No.: 022275 Prod. No.: 001 RX (15MG); 002 RX (30MG) NDA No.: 022275 Prod. No.: 003 DISC (60MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5753677 [Extended 5 years] Benzoheterocyclic compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | May 19, 2020 | U-978: Method of treating hyponatremia |
| Pat. No. 8501730 DS* Process for preparing benzazepine compounds or salts thereof Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Sep 27, 2013 | Sep 1, 2026 |
ATROVENT HFA (AEROSOL, METERED) (INHALATION) IPRATROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021527 Prod. No.: 001 RX (0.021MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6739333 DP* Stainless steel canister for propellant-driven metering aerosols Claim Types: Device Pat. Sub. Date(s): 001: None | May 26, 2020 | |
| Pat. No. 6983743 DP* Stainless steel canister for propellant-driven metering aerosols Claim Types: Device Pat. Sub. Date(s): 001: None | May 26, 2020 | |
| Pat. No. 8474447 DP* Inhaler device Claim Types: Device Pat. Sub. Date(s): 001: May 28, 2015 | Jan 17, 2030 |
EGRIFTA (POWDER) (SUBCUTANEOUS) TESAMORELIN ACETATE
Drug Classes: growth hormone releasing factor (GRG) analog
NDA Applicant: THERATECHNOLOGIES NDA No.: 022505 Prod. No.: 001 RX (EQ 1MG BASE/VIAL); 002 RX (EQ 2MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5861379 DS* DP* [Extended 5 years] Chimeric fatty body-pro-GRF analogs with increased biological potency Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: None | May 26, 2020 | U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy |
| Pat. No. 7144577 Treatment of HIV-associated dysmorphia/dysmetabolic syndrome (HADDS) with or without lipodystrophy Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jul 14, 2020 | U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy |
| Pat. No. 7316997 GH secretagogues and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 14, 2023 | U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy |
| Pat. No. 8314066 GH secretagogues and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 10, 2018; 002: Nov 29, 2018 | Aug 14, 2023 | U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy |
| Pat. No. 8435945 GH secretagogues and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 10, 2018; 002: Nov 29, 2018 | Aug 14, 2023 | U-1100: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy |
VARITHENA (SOLUTION) (INTRAVENOUS) POLIDOCANOL
Drug Classes: sclerosing agent
NDA Applicant: PROVENSIS NDA No.: 205098 Prod. No.: 001 RX (180MG/18ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6572873 Generation of therapeutic microfoam Claim Types: Process Pat. Sub. Date(s): 001: None | May 26, 2020 | U-1461: A method of generating an injectable foam of controlled density and bubble size |
| Pat. No. 6942165 DP* Generation of therapeutic microfoam Claim Types: Device Pat. Sub. Date(s): 001: None | May 26, 2020 | |
| Pat. No. 7025290 DP* Generation of therapeutic microfoam Claim Types: Device; Process Pat. Sub. Date(s): 001: None | May 26, 2020 | U-1461: A method of generating an injectable foam of controlled density and bubble size |
| Pat. No. 7357336 Generation of therapeutic microfoam Claim Types: Process Pat. Sub. Date(s): 001: None | May 26, 2020 | U-1461: A method of generating an injectable foam of controlled density and bubble size |
| Pat. No. 7604185 DS* DP* Generation of therapeutic microfoam Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: None | May 26, 2020 | U-1462: A method of using a sclerosing agent for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous (GSV) system above and below the knee |
| Pat. No. 7842282 Generation of therapeutic microfoam Claim Types: Method of use Pat. Sub. Date(s): 001: None | May 26, 2020 | U-1461: A method of generating an injectable foam of controlled density and bubble size |
| Pat. No. 7842283 DP* Generation of therapeutic microfoam Claim Types: Device Pat. Sub. Date(s): 001: None | May 26, 2020 | |
| Pat. No. 8323677 DS* Therapeutic foam Claim Types: Formulation Pat. Sub. Date(s): 001: None | May 26, 2020 | |
| Pat. No. 8734833 DS* DP* Therapeutic foam Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 19, 2014 | May 26, 2020 | |
| Pat. No. 6846412 DP* Combination filter assembly Claim Types: Device; Process Pat. Sub. Date(s): 001: None | Jul 19, 2022 | |
| Pat. No. 8122917 DP* Apparatus and method for dispensing foam Claim Types: Device; Kit Pat. Sub. Date(s): 001: None | Sep 9, 2024 | |
| Pat. No. 7731986 DS* DP* Therapeutic foam Claim Types: Formulation; Drug in a container; Device; Process; Method of use Pat. Sub. Date(s): 001: None | Nov 17, 2024 | U-1463: A method of intravenous injection using ultrasound guidance, administered via a single cannula into the lumen of the target incompetent trunk veins or by direct injection into varicosities |
| Pat. No. 7814943 DP* Apparatus and method for dispensing foam Claim Types: Device; Kit; Method of use Pat. Sub. Date(s): 001: None | Nov 19, 2027 | U-1461: A method of generating an injectable foam of controlled density and bubble size |
| Pat. No. 9480652 DP* Aerosol valve Claim Types: Device; Process Pat. Sub. Date(s): 001: Nov 30, 2016 | May 12, 2032 |
AMBIEN CR (TABLET, EXTENDED RELEASE) (ORAL) ZOLPIDEM TARTRATE [GENERIC AB]
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: SANOFI AVENTIS US NDA No.: 021774 Prod. No.: 001 RX (12.5MG); 002 RX (6.25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6514531 DP* Controlled-release dosage forms comprising zolpidem or a salt thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 1, 2020 *PED |
ARCAPTA NEOHALER (POWDER) (INHALATION) INDACATEROL MALEATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: SUNOVION PHARMS INC NDA No.: 022383 Prod. No.: 001 RX (EQ 75MCG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8067437 Beta-2-adrenoreceptor agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 26, 2013 | Jun 2, 2020 | U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema |
| Pat. No. 8658673 DS* DP* BETA2-adrenoreceptor agonists Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Jul 28, 2015 | Jun 2, 2020 | U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema |
| Pat. No. 8796307 DS* DP* Beta2-adrenoreceptor agonists Claim Types: Composition Pat. Sub. Date(s): 001: Dec 9, 2015 | Jun 2, 2020 | |
| Pat. No. 6878721 DS* DP* [Extended 1599 days (4.4 years)] Beta2-adrenoceptor agonists Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: None | Feb 25, 2025 | U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema |
| Pat. No. 8479730 DP* Inhaler device Claim Types: Device Pat. Sub. Date(s): 001: Aug 6, 2013 | Oct 11, 2028 |
UTIBRON (POWDER) (INHALATION) GLYCOPYRROLATE ; INDACATEROL MALEATE
Drug Classes: anticholinergic; beta-2 adrenergic agonist
NDA Applicant: SUNOVION PHARMS INC NDA No.: 207930 Prod. No.: 001 RX (15.6MCG/INH;27.5MCG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7820694 DP* Beta-2-adrenoreceptor agonists Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 2, 2020 | U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8067437 Beta-2-adrenoreceptor agonists Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 2, 2020 | U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8283362 DP* Beta-2-adrenoreceptor agonists Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 2, 2020 | U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8658673 DP* BETA2-adrenoreceptor agonists Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 2, 2020 | U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8796307 DP* Beta2-adrenoreceptor agonists Claim Types: Composition Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 2, 2020 | |
| Pat. No. 7229607 Treatment of respiratory disease Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2015 | Apr 9, 2021 | U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8029768 Treatment of respiratory diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2015 | Apr 9, 2021 | U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 7736670 DP* Method of making particles for use in a pharmaceutical composition Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 27, 2021 | |
| Pat. No. 8048451 DP* Pharmaceutical compositions for inhalation Claim Types: Method of use; Product-by-process; Method of improving a treatment; Process Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 27, 2021 | |
| Pat. No. 8303991 DP* Method of making particles for use in a pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 27, 2021 | |
| Pat. No. 8435567 DP* Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 27, 2021 | |
| Pat. No. 8580306 DP* Particles for use in a pharmaceutical composition Claim Types: Formulation; ; Method of use; Process Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 27, 2021 | |
| Pat. No. 8956661 DP* Method of making composite particles for use in pharmaceutical compositions and composite particles and compositions thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Dec 4, 2015 | Jun 27, 2021 | |
| Pat. No. 9931304 DP* Method of making particles for use in a pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: May 2, 2018 | Jun 27, 2021 | |
| Pat. No. 9962338 DP* Method of making particles for use in a pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: May 29, 2018 | Jun 27, 2021 | |
| Pat. No. 6878721 DS* DP* [Extended 1599 days (4.4 years)] Beta2-adrenoceptor agonists Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: Dec 4, 2015 | Feb 25, 2025 | U-1773: Long - term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8479730 DP* Inhaler device Claim Types: Device Pat. Sub. Date(s): 001: Dec 4, 2015 | Oct 11, 2028 | |
| Pat. No. 8182838 DP* Dry powder composition comprising co-jet milled particles for pulmonary inhalation Claim Types: Product-by-process; Drug in a container; Process Pat. Sub. Date(s): 001: Dec 4, 2015 | Oct 20, 2028 |
LIALDA (TABLET, DELAYED RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
NDA Applicant: SHIRE NDA No.: 022000 Prod. No.: 001 RX (1.2GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6773720 DP* Mesalazine controlled release oral pharmaceutical compositions Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None | Jun 8, 2020 |
UCERIS (TABLET, EXTENDED RELEASE) (ORAL) BUDESONIDE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: SALIX NDA No.: 203634 Prod. No.: 001 RX (9MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43799 DP* Controlled release and taste masking oral pharmaceutical composition Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2013 | Jun 9, 2020 | U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis |
| Pat. No. 7410651 DP* Controlled release and taste masking oral pharmaceutical composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 18, 2013 | Jun 9, 2020 | U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis |
| Pat. No. 7431943 DP* Controlled release and taste masking oral pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2013 | Jun 9, 2020 | |
| Pat. No. 8293273 DP* Controlled release and taste masking oral pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2013 | Jun 9, 2020 | |
| Pat. No. 8784888 DP* Controlled release and taste masking oral pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2014 | Jun 9, 2020 | |
| Pat. No. 9320716 DP* Controlled release and taste masking oral pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 5, 2016 | Jun 9, 2020 | U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis |
| Pat. No. 9532954 DP* Controlled release and taste masking oral pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 20, 2017 | Jun 9, 2020 | U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis |
| Pat. No. 10064878 DP* Controlled release and taste masking oral pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 24, 2018 | Jun 9, 2020 | U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis |
| Pat. No. 10105374 DP* Controlled release and taste masking oral pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 9, 2018 | Jun 9, 2020 | U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis |
| Pat. No. 10143698 DP* Controlled release and taste masking oral pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 10, 2018 | Jun 9, 2020 | U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis |
| Pat. No. 8895064 DP* Controlled release and taste masking oral pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 25, 2014 | Sep 7, 2031 | |
| Pat. No. 9132093 DP* Controlled release and taste making oral pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 16, 2015 | Sep 7, 2031 | |
| Pat. No. 9192581 DP* Controlled release and taste masking oral pharmaceutical composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 3, 2015 | Sep 7, 2031 | U-1325: Induction of remission in patients with active, mild to moderate ulcerative colitis |
| Pat. No. 10307375 DP* Controlled release and taste masking oral pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 14, 2019 | Sep 7, 2031 |
QSYMIA (CAPSULE, EXTENDED RELEASE) (ORAL) PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Drug Classes: sympathomimetic amine anorectic
NDA Applicant: VIVUS NDA No.: 022580 Prod. No.: 001 RX (EQ 3.75MG BASE;23MG); 002 RX (EQ 7.5MG BASE;46MG); 003 RX (EQ 11.25MG BASE;69MG); 004 RX (EQ 15MG BASE;92MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7056890 DP* Combination therapy for effecting weight loss and treating obesity Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Aug 16, 2012; 002: None; 003: None; 004: None | Jun 14, 2020 | U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight |
| Pat. No. 7553818 Combination therapy for effecting weight loss and treating obesity Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2012; 002: None; 003: None; 004: None | Jun 14, 2020 | U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight |
| Pat. No. 7659256 DP* Combination therapy for effecting weight loss and treating obesity Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Aug 16, 2012; 002: None; 003: None; 004: None | Jun 14, 2020 | U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight |
| Pat. No. 7674776 DP* Combination therapy for effecting weight loss and treating obesity Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 16, 2012; 002: None; 003: None; 004: None | Jun 14, 2020 | U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight |
| Pat. No. 8895057 Escalating dosing regimen for effecting weight loss and treating obesity Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Dec 18, 2014 | Jun 9, 2028 | U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight |
| Pat. No. 8895058 DP* Low dose topiramate/phentermine composition and methods of use thereof Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): All strengths: Dec 18, 2014 | Jun 9, 2028 | |
| Pat. No. 9011905 DP* Low dose topiramate/phentermine composition and methods of use thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 13, 2015 | Jun 9, 2028 | |
| Pat. No. 9011906 Escalating dosing regimen for effecting weight loss and treating obesity Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: May 13, 2015 | Jun 9, 2028 | U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight |
| Pat. No. 8580298 DP* Low dose topiramate/phentermine composition and methods of use thereof Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Nov 14, 2013; 002: None; 003: None; 004: None | May 15, 2029 | |
| Pat. No. 8580299 Escalating dosing regimen for effecting weight loss and treating obesity Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2013; 002: None; 003: None; 004: None | Jun 14, 2029 | U-1262: Use of QSYMIA (phentermine and topiramate) for weight management, including, but not limited to effecting weight loss, treating obesity, and/or treating overweight |
DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022287 Prod. No.: 001 RX (30MG); 002 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9145389 DS* DP* Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition Pat. Sub. Date(s): All strengths: Oct 27, 2015 | Jun 15, 2020 | |
| Pat. No. 6462058 DS* DP* Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Composition; Process; Method of use Pat. Sub. Date(s): All strengths: None | Dec 15, 2020 *PED | U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 6939971 Benzimidazole compound crystal Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Dec 15, 2020 *PED | U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 7285668 DS* Process for the crystallization of (R)- or (S)-lansoprazole Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: None | Dec 15, 2020 *PED | |
| Pat. No. 6664276 DS* DP* [Extended 959 days (2.6 years)] Benzimidazole compound crystal Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Pat. Sub. Date(s): All strengths: None | Jul 30, 2023 *PED | U-1507: To maintain healing of EE and relief of heartburn U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 8722084 DP* Controlled release preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 9, 2014 | Apr 15, 2024 *PED | |
| Pat. No. 8784885 DP* Controlled release preparation Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 19, 2014 | Apr 15, 2024 *PED | U-1552: For healing of all grades of erosive esophagitis (EE) U-1553: To maintain healing of EE and relief of heartburn U-1554: For the treatment of heartburn associated with symptomatic non-erosive gastroesophageal disease (GERD) |
| Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Jan 17, 2026 | |
| Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: May 1, 2015 | Feb 24, 2026 | |
| Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jul 17, 2026 *PED | |
| Pat. No. 7790755 DP* Controlled release preparation Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 29, 2010; 002: None | Feb 2, 2027 *PED | |
| Pat. No. 8105626 DP* Granules containing acid-unstable chemical in large amount Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 28, 2012; 002: None | Mar 27, 2027 *PED | |
| Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014 | Jan 11, 2028 | |
| Pat. No. 8173158 Methods of treating gastrointestinal disorders independent of the intake of food Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 1, 2012; 002: None | Sep 17, 2030 *PED | U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 9233103 Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Mar 5, 2032 | U-1805: Use of dexlansoprazole in patients taking clopidogrel without meaningful cyp2c19 interactions |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jul 8, 2019 |
APTENSIO XR (CAPSULE, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [GENERIC AB3]
Drug Classes: central nervous system stimulant
NDA Applicant: RHODES PHARMS NDA No.: 205831 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (40MG); 006 RX (50MG); 007 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6419960 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 7083808 DP* Controlled/modified release oral methylphenidate formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 7247318 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 7438930 DP* DLR* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 8580310 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 18, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 9066869 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 27, 2015 | Jun 16, 2020 *PED | |
| Pat. No. 9801823 DP* Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 29, 2017 | Jun 16, 2020 *PED | |
| Pat. No. 10039719 Methods of treating attention deficit hyperactivity disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2018 | Jun 16, 2020 *PED | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
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. 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. 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. 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. 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. 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. 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. 7384649 DP* Particulate compositions for pulmonary delivery Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 18, 2019 | Nov 20, 2022 | |
| Pat. No. 8404276 Pulmonary delivery for levodopa Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 18, 2019 | Mar 19, 2023 | U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles |
| Pat. No. 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. 9155699 DP* Pulmonary delivery for levodopa Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 18, 2019 | Mar 19, 2023 | |
| 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. 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. 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. 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. 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 |
GLUMETZA (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE [GENERIC AB3]
Drug Classes: biguanide
NDA Applicant: SANTARUS INC NDA No.: 021748 Prod. No.: 001 RX (500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6488962 DS* DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Claim Types: Composition Pat. Sub. Date(s): 001: None | Jun 20, 2020 | |
| Pat. No. 6723340 DS* DP* Optimal polymer mixtures for gastric retentive tablets Claim Types: Formulation Pat. Sub. Date(s): 001: None | Oct 25, 2021 |
GRALISE (TABLET) (ORAL) GABAPENTIN [Has competitive generic]
Drug Classes: antiepileptic drug (AED)
NDA Applicant: ASSERTIO NDA No.: 022544 Prod. No.: 001 RX (300MG); 002 RX (600MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Claim Types: Composition Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None | Jun 20, 2020 | |
| Pat. No. 6723340 DP* Optimal polymer mixtures for gastric retentive tablets Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None | Oct 25, 2021 | |
| Pat. No. 7731989 DP* Gastric retained gabapentin dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None | Oct 25, 2022 | |
| Pat. No. 8192756 DP* Gastric retained gabapentin dosage form Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: Jun 8, 2012 | Oct 25, 2022 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
| Pat. No. 8252332 DP* Gastric retained gabapentin dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 17, 2012; 002: None | Oct 25, 2022 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
| Pat. No. 8333992 DP* Gastric retained gabapentin dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 17, 2013; 002: None | Oct 25, 2022 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
| Pat. No. 7438927 Methods of treatment using a gastric retained gabapentin dosage Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 28, 2011; 002: None | Feb 26, 2024 | U-1114: Treatment with gabapentin, including treatment of neuropathic pain, including neuropathic pain associated with postherpetic neuralgia |
PROQUIN XR (TABLET, EXTENDED RELEASE) (ORAL) CIPROFLOXACIN HYDROCHLORIDE
Drug Classes: quinolone antimicrobial
NDA Applicant: DEPOMED INC NDA No.: 021744 Prod. No.: 001 DISC (EQ 500MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Claim Types: Composition Pat. Sub. Date(s): 001: None | Jun 20, 2020 |
SYNJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor; biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 208658 Prod. No.: 001 RX (5MG;1GM); 002 RX (10MG;1GM); 003 RX (12.5MG;1GM); 004 RX (25MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Claim Types: Composition Pat. Sub. Date(s): All strengths: Jan 4, 2017 | Jun 20, 2020 | |
| Pat. No. 7579449 DS* Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Claim Types: Compound Pat. Sub. Date(s): All strengths: Jan 4, 2017 | Nov 5, 2025 | |
| Pat. No. 7713938 DS* DP* Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Jan 4, 2017 | Apr 15, 2027 | |
| Pat. No. 10258637 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): All strengths: Apr 30, 2019 | Apr 3, 2034 | U-2290: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=EGFR<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin |
| Pat. No. 9949998 Pharmaceutical composition, methods for treating and uses thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 16, 2018 | Jun 11, 2034 | U-2290: Method of treating Type 2 diabetes mellitus in a patient with renal impairment (45 ml/min/1.73 m2<=EGFR<60 ml/min/1.73 m2) by once daily administration of 10 mg or 25 mg of empagliflozin |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 2, 2019 | I-739: To reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and established cardiovascular disease |
| Exclusivity Code: NCE - New chemical entity | Aug 1, 2019 |
XARTEMIS XR (TABLET, EXTENDED RELEASE) (ORAL) ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: MALLINCKRODT INC NDA No.: 204031 Prod. No.: 001 DISC (325MG;7.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6488962 DP* Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Claim Types: Composition Pat. Sub. Date(s): 001: Apr 3, 2014 | Jun 20, 2020 | |
| Pat. No. 7976870 Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Apr 3, 2014 | Jun 1, 2027 | U-1498: Method of treating patients with gastric retentive dosage form |
| Pat. No. 8372432 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 3, 2014 | Mar 11, 2029 | U-1499: Management of acute pain in patients requiring opioid analgesia |
| Pat. No. 8394408 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2014 | Mar 11, 2029 | |
| Pat. No. 8668929 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 3, 2014 | Mar 11, 2029 | U-1499: Management of acute pain in patients requiring opioid analgesia |
| Pat. No. 8377453 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Apr 3, 2014 | Nov 19, 2029 | U-1499: Management of acute pain in patients requiring opioid analgesia |
| Pat. No. 8597681 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Apr 3, 2014 | Dec 21, 2030 | |
| Pat. No. 8980319 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2015 | Dec 21, 2030 | |
| Pat. No. 8658631 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2014 | May 16, 2032 | |
| Pat. No. 8741885 DP* Gastric retentive extended release pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 17, 2014 | May 16, 2032 | U-1499: Management of acute pain in patients requiring opioid analgesia |
| Pat. No. 8992975 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 3, 2015 | May 16, 2032 | |
| Pat. No. 9050335 DP* Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia Claim Types: Formuation Pat. Sub. Date(s): 001: Jun 25, 2015 | May 16, 2032 | |
| Pat. No. 9468636 Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2016 | May 16, 2032 | U-1499: Management of acute pain in patients requiring opioid analgesia |
XYREM (SOLUTION) (ORAL) SODIUM OXYBATE [GENERIC AA]
Drug Classes: central nervous system depressant
NDA Applicant: JAZZ PHARMS NDA No.: 021196 Prod. No.: 001 RX (500MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7851506 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jun 22, 2020 *PED | U-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy U-1102: Method of treating cataplexy in patients with narcolepsy |
| Pat. No. 8263650 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Claim Types: Formulation; Method of use; Kit Pat. Sub. Date(s): 001: Sep 20, 2012 | Jun 22, 2020 *PED | U-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy U-1102: Method of treating cataplexy in patients with narcolepsy |
| Pat. No. 8324275 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 5, 2012 | Jun 22, 2020 *PED | U-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy U-1102: Method of treating cataplexy in patients with narcolepsy |
| Pat. No. 8859619 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Oct 28, 2014 | Jun 22, 2020 *PED | |
| Pat. No. 8952062 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 19, 2015 | Jun 22, 2020 *PED | U-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy U-1102: Method of treating cataplexy in patients with narcolepsy |
| Pat. No. 9539330 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Feb 8, 2017 | Jun 22, 2020 *PED | |
| Pat. No. 6780889 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 4, 2021 *PED | |
| Pat. No. 7262219 DP* Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jan 4, 2021 *PED | |
| Pat. No. 8731963 Sensitive drug distribution system and method Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: May 30, 2014 | Jun 17, 2023 *PED | U-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution |
| Pat. No. 7668730 DLR* Sensitive drug distribution system and method Claim Types: Method of distribution Pat. Sub. Date(s): 001: None | Dec 16, 2024 *PED | U-1110: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution |
| Pat. No. 10213400 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 15, 2033 | U-2499: Method of reducing adverse effects in patients suffering from excessive daytime sleepiness and/or cataplexy in narcolepsy who are concomitantly administered sodium oxybate and divalproex sodium |
| Pat. No. 8772306 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 9, 2014 | Sep 15, 2033 *PED | U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered. |
| Pat. No. 9050302 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of administration; method of improving a treatment Pat. Sub. Date(s): 001: Jul 8, 2015 | Sep 15, 2033 *PED | U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered. |
| Pat. No. 9486426 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 6, 2016 | Sep 15, 2033 *PED | U-1532: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with sodium oxybate when divalproex sodium is concomitantly administered. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Apr 26, 2022 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 26, 2025 | ODE-231: Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in pediatric patients 7 years of age and older with narcolepsy |
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 |
AFREZZA (POWDER) (INHALATION) INSULIN RECOMBINANT HUMAN
Drug Classes: insulin analog
NDA Applicant: MANNKIND NDA No.: 022472 Prod. No.: 001 RX (4 UNITS/INH); 002 RX (8 UNITS/INH); 003 RX (12 UNITS/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6444226 DP* Purification and stabilization of peptide and protein pharmaceutical agents Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Jun 29, 2020 | U-1534: Administration of a composition comprising insulin complexed with a diketopiperazine. |
| Pat. No. 6652885 Purification and stabilization of peptide and protein pharmaceutical agents Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Jun 29, 2020 | U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine. |
| Pat. No. 7648960 Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Jun 29, 2020 | U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine. |
| Pat. No. 7943178 DP* Methods and compositions for delivering peptides Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Jun 29, 2020 | U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine. |
| Pat. No. 8389470 DP* Methods and compositions for delivering peptides Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Jun 29, 2020 | U-1621: Pulmonary administration of a composition comprising insulin bound to a complexing agent. |
| Pat. No. 8889099 DP* Methods and compositions for delivering peptides Claim Types: Method of administration; Formulation Pat. Sub. Date(s): All strengths: Dec 17, 2014 | Jun 29, 2020 | U-1621: Pulmonary administration of a composition comprising insulin bound to a complexing agent. |
| Pat. No. 8950397 DP* Unit dose cartridge and dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Apr 25, 2016 | Jul 20, 2021 | |
| Pat. No. 8215300 DP* Unit dose cartridge and dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Nov 24, 2022 | |
| Pat. No. 7305986 DP* Unit dose capsules for use in a dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Jan 16, 2023 | |
| Pat. No. 8156936 DP* Unit dose capsules and dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Jan 16, 2023 | |
| Pat. No. 7464706 DP* Unit dose cartridge and dry powder inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Mar 2, 2023 | |
| Pat. No. 8146588 DP* Unit dose capsules and dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Apr 24, 2023 | |
| Pat. No. 7943572 Superior control of blood glucose in diabetes treatment Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Aug 10, 2026 | U-1539: Pulmonary administration of an insulin composition comprising FDKP at the beginning of a meal to a patient also being treated with a long-acting insulin. |
| Pat. No. 9283193 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 12, 2016 | Sep 14, 2026 | |
| Pat. No. 9717689 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 28, 2017 | Sep 14, 2026 | |
| Pat. No. 8729019 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 14, 2014; 003: May 15, 2015 | Dec 26, 2028 | |
| Pat. No. 8912193 DP* Dry powder inhaler and system for drug delivery Claim Types: Composition; Method of use; Product-by-process; Method of administration Pat. Sub. Date(s): All strengths: Aug 18, 2015 | Jun 12, 2029 | U-1538: Administration of FDKP microparticles comprising insulin. |
| Pat. No. 9192675 DP* Dry powder inhaler and system for drug delivery Claim Types: Device; Drug in a container Pat. Sub. Date(s): All strengths: Dec 23, 2015 | Jun 12, 2029 | U-1788: Treatment of patient having diabetes mellitus via oral inhalation of fdkp microparticles comprising insulin |
| Pat. No. 9446133 DP* Dry powder inhaler and system for drug delivery Claim Types: Composition; Formulation; Method of use; Method of administration Pat. Sub. Date(s): All strengths: Oct 19, 2016 | Jun 12, 2029 | U-1861: Use of an inhaler to administer dry powder medicament |
| Pat. No. 9662461 DP* Dry powder drug delivery system and methods Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jun 26, 2017 | Jun 12, 2029 | U-2019: Method of delivering to a patient with diabetes mellitus in a single inhalation, greater than 75% of a dry powder dose comprising insulin and fumaryl diketopiperazine using a high resistance to flow dry powder inhaler. |
| Pat. No. 10342938 DP* Dry powder drug delivery system Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 23, 2019 | Jun 12, 2029 | |
| Pat. No. 9393372 DP* Dry powder drug delivery system Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016 | Jul 4, 2029 | |
| Pat. No. 8119593 Method of treating diabetes type 2 by metformin and an ultrarapid acting insulin Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Aug 11, 2029 | U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin. |
| Pat. No. 8258095 Method of controlling glycemia by ultrarapid acting insulin without adjusting an insulin dose for meal content Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Aug 11, 2029 | U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin. |
| Pat. No. 9943571 Use of ultrarapid acting insulin Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 15, 2018 | Aug 11, 2029 | U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin. |
| Pat. No. 10046031 Use of ultrarapid acting insulin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 12, 2018 | Aug 11, 2029 | U-2383: Method of controlling glycemia in a diabetic patient with delayed or prolonged food absorpbtion by administering 50 to 75% of a predetermined dose of insulin-FDKP at mealtime, and administering remainder of dose 30-120 minutes after beginning of meal |
| Pat. No. 8623817 Method of treating diabetes type 2 by administering ultrarapid acting insulin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Sep 18, 2029 | U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin. |
| Pat. No. 9339615 DP* Dry powder inhaler and system for drug delivery Claim Types: Device Pat. Sub. Date(s): All strengths: May 31, 2016 | Oct 20, 2029 | |
| Pat. No. 9511198 Dry powder inhaler and system for drug delivery Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 5, 2017 | Feb 16, 2030 | U-1929: Treatment of diabetes mellitus with an inhaled insulin to improve glycemic control using a dry powder inhalation system comprising an inhaler, a cartridge and a dry powder medicament comprising insulin in a single inhalation U-1930: Method of aerosolizing/deagglomerating an insulin dry powder for use in treating diabetes mellitus via oral inhalation using an inhaler with a cartridge containing the insulin dry powder. |
| Pat. No. 8485180 DP* Dry powder drug delivery system Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Mar 25, 2030 | |
| Pat. No. 8551528 DP* Diketopiperazine microparticles with defined specific surface areas Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Jun 11, 2030 | |
| Pat. No. 8734845 DP* Diketopiperazine microparticles with defined specific surface areas Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Jun 11, 2030 | |
| Pat. No. 8778403 DP* Diketopiperazine microparticles with defined specific surface areas Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jul 24, 2014 | Jun 11, 2030 | U-1538: Administration of FDKP microparticles comprising insulin. |
| Pat. No. 10201672 DP* Dry powder inhaler and system for drug delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 4, 2019 | Aug 2, 2030 | |
| Pat. No. 9358352 DP* Dry powder drug delivery system and methods Claim Types: Device; Drug in a container; Method of administration Pat. Sub. Date(s): All strengths: Jun 30, 2016 | Feb 15, 2031 | U-1861: Use of an inhaler to administer dry powder medicament |
| Pat. No. 9597374 Use of ultrarapid acting insulin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 11, 2017 | Oct 8, 2031 | U-1987: Method of controlling glycemia in diabetics by administering an initial dose of insulin-FDKP with a meal; determining blood glucose level 1-2 hrs after and administering a supplemental dose of insulin-FDKP if postprandial glucose level is >140 mg/dl |
| Pat. No. 8424518 DP* Dry powder inhaler and system for drug delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Oct 17, 2031 | |
| Pat. No. 8499757 DP* Dry powder inhaler and system for drug delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Feb 19, 2032 | |
| Pat. No. 8636001 DP* Dry powder inhaler and system for drug delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 | Jul 12, 2032 |
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 |
RYZOLT (TABLET, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA NDA No.: 021745 Prod. No.: 001 DISC (100MG**); 002 DISC (200MG**); 003 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. 7988998 DP* Sustained-release tramadol formulations with 24-hour efficacy Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None | Oct 27, 2023 |
STALEVO 50; STALEVO 100; STALEVO 150; STALEVO 200; STALEVO 75; STALEVO 125 (TABLET) (ORAL) CARBIDOPA; ENTACAPONE; LEVODOPA [GENERIC AB]
Drug Classes: aromatic amino acid decarboxylation inhibitor; catechol o-methyl transferase (COMT) inhibitor
NDA Applicant: ORION PHARMA NDA No.: 021485 Prod. No.: 001 RX (12.5MG;200MG;50MG); 002 RX (25MG;200MG;100MG); 003 RX (37.5MG;200MG;150MG); 004 RX (50MG;200MG;200MG); 005 RX (18.75MG;200MG;75MG); 006 RX (31.25MG;200MG;125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6500867 DP* Pharmaceutical composition comprising entacapone, levodopa, and carbidopa Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 29, 2020 | U-219: Treatment of Parkinson's disease |
| Pat. No. 6797732 DP* Pharmaceutical composition comprising entracapone, levodopa, and carbidopa Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: None | Jun 29, 2020 |
INLYTA (TABLET) (ORAL) AXITINIB
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV NDA No.: 202324 Prod. No.: 001 RX (1MG); 002 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7141581 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 16, 2012; 002: None | Jun 30, 2020 | U-1220: Treatment of renal cell carcinoma |
| Pat. No. 6534524 DS* DP* [Extended 1764 days (4.8 years)] Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Feb 16, 2012; 002: None | Apr 29, 2025 | |
| Pat. No. 8791140 DS* Crystalline forms of 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyondazole suitable for the treatment of abnormal cell growth in mammals Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None | Dec 14, 2030 |
LIDOSITE TOPICAL SYSTEM KIT (PATCH) (IONTOPHORESIS, TOPICAL) EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI); norepinephrine-releasing agent; alpha adrenergic agonist; beta adrenergic agonist; catecholamine; norepinephrine, serotonin, and dopamine reuptake inhibitor anorectic; amide local anesthetic; antiarrhythmic
NDA Applicant: VYTERIS NDA No.: 021504 Prod. No.: 001 DISC (1.05MG/PATCH;100MG/PATCH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6629968 DS* DP* Shelf storage stable iontophoresis reservoir-electrode and iontophoretic system incorporating the reservoir-electrode Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Jun 30, 2020 | |
| Pat. No. 6635045 DS* DP* Electrodes and method for manufacturing electrodes for electrically assisted drug delivery Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None | Jun 29, 2021 |
DUAKLIR PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Drug Classes: anticholinergic; beta-2 adrenergic agonist
NDA Applicant: CIRCASSIA NDA No.: 210595 Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7078412 DS* DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 7750023 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8129405 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9056100 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9333195 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 10034867 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) U-2514: Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 6681768 DP* Powder formulation disintegrating system and method for dry powder inhalers Claim Types: Device Pat. Sub. Date(s): 001: Apr 24, 2019 | Aug 7, 2022 | |
| Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)] Quinuclidine derivatives and their use as muscarinic M3 receptor ligands Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): 001: Apr 24, 2019 | Feb 10, 2025 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 24, 2019 | Apr 22, 2027 | |
| Pat. No. 10085974 DP* Dosage and formulation Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): 001: Apr 24, 2019 | Mar 13, 2029 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Mar 29, 2022 |
SYNERA (PATCH) (TOPICAL) LIDOCAINE; TETRACAINE
Drug Classes: amide local anesthetic; antiarrhythmic; ester local anesthetic
NDA Applicant: GALEN SPECIALTY NDA No.: 021623 Prod. No.: 001 RX (70MG;70MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6465709 DP* Exothermic bandage Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jul 19, 2012 | Jul 7, 2020 |
TUDORZA PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: CIRCASSIA NDA No.: 202450 Prod. No.: 001 RX (0.4MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7078412 DS* DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 17, 2012 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9056100 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 15, 2015 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 9333195 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jun 8, 2016 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 10034867 DP* Quinuclidine derivatives and medicinal compositions containing the same Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Oct 25, 2018 | Jul 7, 2020 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) U-2514: Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) |
| Pat. No. 6681768 DP* Powder formulation disintegrating system and method for dry powder inhalers Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2012 | Aug 7, 2022 | |
| Pat. No. RE46417 DS* DP* [Extended 1679 days (4.6 years)] Quinuclidine derivatives and their use as muscarinic M3 receptor ligands Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): 001: Jun 28, 2017 | Feb 10, 2025 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
| Pat. No. 8051851 DP* Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler Claim Types: Device Pat. Sub. Date(s): 001: Aug 17, 2012 | Apr 22, 2027 | |
| Pat. No. 10085974 DP* Dosage and formulation Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): 001: Oct 26, 2018 | Mar 13, 2029 | U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD) |
ADLYXIN (SOLUTION) (SUBCUTANEOUS) LIXISENATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: SANOFI-AVENTIS US NDA No.: 208471 Prod. No.: 001 RX (0.15MG/3ML (0.05MG/ML)); 002 RX (0.3MG/3ML (0.1MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE45313 DS* DP* Exendin variant peptides Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Aug 3, 2016 | Jul 12, 2020 | |
| Pat. No. 9855388 DP* Dosing and drive mechanism for drug delivery device Claim Types: Device; Process; Method of administration Pat. Sub. Date(s): All strengths: Jan 12, 2018 | Apr 24, 2029 | U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector |
| Pat. No. 8915888 DP* Dosing and drive mechanism for drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016 | Jun 8, 2030 | U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector |
| Pat. No. 9981013 Use of AVE0010 for the treatment of diabetes mellitus type 2 Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 8, 2018 | Aug 30, 2030 | U-2297: Improvement of glycemic control in Type 2 diabetes patients by administering a starting dose of 10 mcg for 14 days and increasing to a maintenance dose of 20 mcg on day 15 |
| Pat. No. 9707176 DP* Pharmaceutical composition comprising a GLP-1 agonist and methionine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 3, 2017 | Nov 11, 2030 | |
| Pat. No. 10028910 DP* Pharmaceutical composition comprising a GLP-1-agonist and methionine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 30, 2018 | Nov 11, 2030 | |
| Pat. No. 8475414 DP* Medication delivery device and method for operating a medication delivery device Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Aug 3, 2016 | Dec 28, 2030 | U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector |
| Pat. No. 9308329 DP* Medication delivery device and method for operating a medication delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016 | Dec 28, 2030 | U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector |
| Pat. No. 8882721 DP* Drive assembly suitable for use in a drug delivery device and drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016 | Jun 28, 2031 | |
| Pat. No. 9084853 DP* Drive mechanism for a drug delivery device and drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016 | Oct 5, 2031 | |
| Pat. No. 9511193 DP* Assembly and indicator for a drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 29, 2016 | Jan 19, 2032 | |
| Pat. No. 9440029 DP* Drive mechanism for a drug delivery device and drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 29, 2016 | Jan 30, 2032 | |
| Pat. No. 9072836 DP* Drive mechanism for a drug delivery device and drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016 | Mar 15, 2032 | |
| Pat. No. 9821032 Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 19, 2017 | May 9, 2032 | U-2200: Combination treatment with insulin glargine with or without metformin for improvement of glycemic control in Type 2 diabetes mellitus patients |
| Pat. No. 9408893 Pharmaceutical combination for use in glycemic control in diabetes type 2 patients Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 9, 2016 | Aug 27, 2032 | U-1894: Combination treatment with a glitazone for improvement of glycemic control in Type 2 diabetes mellitus patients |
| Pat. No. 10201663 DP* Assembly for a drug delivery device Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Jul 9, 2019 | Mar 10, 2034 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 27, 2021 |
SOLIQUA 100/33 (SOLUTION) (SUBCUTANEOUS) INSULIN GLARGINE; LIXISENATIDE
Drug Classes: insulin analog; glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: SANOFI-AVENTIS US NDA No.: 208673 Prod. No.: 001 RX (300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE45313 DS* DP* Exendin variant peptides Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Nov 23, 2016 | Jul 12, 2020 | |
| Pat. No. 8603044 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Nov 23, 2016 | Mar 2, 2024 | |
| Pat. No. 9233211 DP* Relating to a pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Nov 23, 2016 | Mar 2, 2024 | |
| Pat. No. 9408979 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Nov 23, 2016 | Mar 2, 2024 | |
| Pat. No. 9526844 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Dec 27, 2016 | Mar 2, 2024 | |
| Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Mar 28, 2017 | Mar 2, 2024 | |
| Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Apr 4, 2017 | Mar 2, 2024 | |
| Pat. No. 9775954 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Oct 3, 2017 | Mar 2, 2024 | |
| Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Nov 28, 2017 | Mar 2, 2024 | U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve |
| Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Nov 23, 2016 | Mar 3, 2024 | |
| Pat. No. 9011391 Pen-type injector Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 23, 2016 | Mar 26, 2024 | U-1923: Improvement in glycemic control in adults with Type 2 diabetes mellitus inadequately controlled by basal insulin or lixisenatide by use of a pen injector with a threaded drive sleeve U-2496: Improvement in glycemic control in adults with Type 2 diabetes mellitus by use of a pen injector with a threaded drive sleeve |
| Pat. No. 8992486 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Nov 23, 2016 | Jun 5, 2024 | |
| Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Mar 28, 2017 | Aug 16, 2024 | |
| Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Jan 3, 2017 | Aug 17, 2024 | |
| Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Apr 18, 2017 | Aug 19, 2024 | |
| Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 001: Feb 7, 2017 | Aug 28, 2024 | |
| Pat. No. 8512297 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Nov 23, 2016 | Sep 15, 2024 | |
| Pat. No. 8679069 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Nov 23, 2016 | Apr 12, 2025 | |
| Pat. No. 7918833 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Nov 23, 2016 | Sep 23, 2027 | |
| Pat. No. 9526764 DP* Combination of an insulin and a GLP-1-agonist Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 5, 2017 | Oct 9, 2029 | |
| Pat. No. 10117909 DP* Combination of an insulin and a GLP-1 agonist Claim Types: Drug in a container Pat. Sub. Date(s): 001: Nov 27, 2018 | Oct 9, 2029 | |
| Pat. No. 9707176 DP* Pharmaceutical composition comprising a GLP-1 agonist and methionine Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 3, 2017 | Nov 11, 2030 | |
| Pat. No. 10029011 DP* Pharmaceutical composition comprising a GLP-1 agonist, an insulin and methionine Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 30, 2018 | Nov 11, 2030 | |
| Pat. No. 9821032 Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2017 | May 9, 2032 | U-2182: Improvement of glycemic control in Type 2 diabetes mellitus patients |
| Pat. No. 9717852 DP* Cartridge holder and pen-type injector Claim Types: Device Pat. Sub. Date(s): 001: Jul 12, 2018 | Apr 8, 2033 | |
| Pat. No. 9950039 Insulin glargine/lixisenatide fixed ratio formulation Claim Types: Method of use Pat. Sub. Date(s): 001: May 4, 2018 | Dec 10, 2035 | U-2277: Improvement in glycemic control in adults with Type 2 diabetes mellitus inadequately controlled by lixisenatide U-2278: Improvement in glycemic control in adults with Type 2 diabetes mellitus inadequately controlled by lixisenatide in combination with metformin U-2279: Improvement in glycemic control in adults with Type 2 diabetes mellitus inadequately controlled by lixisenatide in combination with metformin and a second oral antidiabetic drug |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | Nov 21, 2019 | |
| Exclusivity Code: NCE - New chemical entity | Jul 27, 2021 |
CLEOCIN (SUPPOSITORY) (VAGINAL) CLINDAMYCIN PHOSPHATE
Drug Classes: lincosamide antibacterial
NDA Applicant: PHARMACIA AND UPJOHN NDA No.: 050767 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6495157 DP* Intravaginal clindamycin ovule composition Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 20, 2020 |
OSPHENA (TABLET) (ORAL) OSPEMIFENE
Drug Classes: estrogen agonist/antagonist
NDA Applicant: DUCHESNAY NDA No.: 203505 Prod. No.: 001 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9566252 Method for the alleviation of dyspareunia in women Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 6, 2017 | Jul 21, 2020 | U-1370: Treatment of dyspareunia associated with menopause |
| Pat. No. 8470890 Method for enhancing the bioavailability of ospemifene Claim Types: Method of use Pat. Sub. Date(s): 001: None | Feb 13, 2024 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 8772353 Method for enhancing the bioavalability of ospemifene Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2014 | Feb 13, 2024 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 9241915 Method for enhancing the bioavailability of ospemifene Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Feb 10, 2016 | Feb 13, 2024 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 9855224 Method for enhancing the bioavailability of ospemifene Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 23, 2018 | Feb 13, 2024 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 6245819 [Extended 5 years] Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 25, 2013 | Jul 21, 2025 | U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 8236861 Method for enhancing the bioavailablity of ospemifene Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 25, 2013 | Aug 11, 2026 | U-1369: Treatment of vaginal symptoms of urogenital atrophy by orally administering ospemifene with food to enhance bioavailability of ospemifene U-1370: Treatment of dyspareunia associated with menopause U-905: Treatment of moderate to severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause |
| Pat. No. 8642079 DP* Solid formulations of ospemifene Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 20, 2014 | Jul 9, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 25, 2022 | I-793: Treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause |
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER (SOLUTION) (INTRAVENOUS) MOXIFLOXACIN HYDROCHLORIDE
Drug Classes: quinolone antimicrobial
NDA Applicant: BAYER HLTHCARE NDA No.: 021277 Prod. No.: 001 DISC (400MG/250ML (1.6MG/ML)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6548079 DP* Moxifloxacin formulation containing common salt Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: None | Jul 25, 2020 | U-298: Method of combating bacteria in a patient |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Sep 27, 2019 | M-185: Updates to the labeling to include results of a trial to evaluate the safety of moxifloxacin in pediatric patients with complicated intra-abdominal infections |
MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI NDA No.: 202611 Prod. No.: 001 RX (25MG); 002 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6562375 DP* Stable pharmaceutical composition for oral use Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | Aug 1, 2020 | |
| Pat. No. 6346532 DS* DP* [Extended 1259 days (3.4 years)] Amide derivatives or salts thereof Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | Mar 27, 2022 | |
| Pat. No. RE44872 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 16, 2014 | Nov 4, 2023 | U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 7342117 DS* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | Nov 4, 2023 | |
| Pat. No. 7982049 DP* .alpha.-form or .beta.-form crystal of acetanilide derivative Claim Types: Composition; Method of use; Formulation Pat. Sub. Date(s): 001: Jul 30, 2012; 002: None | Nov 4, 2023 | |
| Pat. No. 8835474 Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 14, 2014 | Nov 4, 2023 | U-1527: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Pat. No. 8772315 Pharmaceutical composition for treating overactive bladder Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 17, 2018 | Oct 30, 2028 | U-2300: Use in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Apr 27, 2021 | I-777: Co-administration therapy of mirabegron with solifenacin succinate for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency |
ALTRENO (LOTION) (TOPICAL) TRETINOIN
Drug Classes: retinoid
NDA Applicant: DOW PHARM NDA No.: 209353 Prod. No.: 001 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6517847 DP* Topical gel delivery system Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Aug 30, 2018 | Aug 3, 2020 | U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | Aug 23, 2021 |
BRYHALI (LOTION) (TOPICAL) HALOBETASOL PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: BAUSCH NDA No.: 209355 Prod. No.: 001 RX (0.01%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6517847 DP* Topical gel delivery system Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: May 13, 2019 | Aug 3, 2020 | |
| Pat. No. 8809307 DP* Pharmaceutical formulations containing corticosteroids for topical administration Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 13, 2019 | Nov 2, 2031 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Nov 6, 2021 |
CLINDAGEL (GEL) (TOPICAL) CLINDAMYCIN PHOSPHATE [Has competitive generic]
Drug Classes: lincosamide antibacterial
NDA Applicant: BAUSCH NDA No.: 050782 Prod. No.: 001 RX (EQ 1% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6387383 DP* Topical low-viscosity gel composition Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | Aug 3, 2020 | U-818: Topical treatment of acne vulgaris |
DESONATE (GEL) (TOPICAL) DESONIDE
Drug Classes: corticosteroid
NDA Applicant: LEO PHARMA AS NDA No.: 021844 Prod. No.: 001 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6387383 DS* DP* Topical low-viscosity gel composition Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | Aug 3, 2020 | U-783: DESONATE gel is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older |
DUOBRII (LOTION) (TOPICAL) HALOBETASOL PROPIONATE; TAZAROTENE
Drug Classes: corticosteroid; retinoid
NDA Applicant: BAUSCH NDA No.: 209354 Prod. No.: 001 RX (0.01%;0.045%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6517847 DP* Topical gel delivery system Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Apr 30, 2019 | Aug 3, 2020 | |
| Pat. No. 8809307 DP* Pharmaceutical formulations containing corticosteroids for topical administration Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 30, 2019 | Nov 2, 2031 | |
| Pat. No. 10251895 DP* Topical compositions and methods for treating psoriasis Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 26, 2019 | Jun 6, 2036 | |
| Pat. No. 10426787 Topical compositions and methods for treating psoriasis Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 9, 2019 | Jun 6, 2036 | U-2625: Topical treatment of plaque psoriasis in adults |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Apr 25, 2022 |
ZIANA (GEL) (TOPICAL) CLINDAMYCIN PHOSPHATE; TRETINOIN [GENERIC AB]
Drug Classes: lincosamide antibacterial; retinoid
NDA Applicant: MEDICIS NDA No.: 050802 Prod. No.: 001 RX (1.2%;0.025%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6387383 DP* Topical low-viscosity gel composition Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: None | Aug 3, 2020 | U-916: Topical treatment of acne vulgaris in patients 12 years or older |
BRIDION (SOLUTION) (INTRAVENOUS) SUGAMMADEX SODIUM
NDA Applicant: ORGANON SUB MERCK NDA No.: 022225 Prod. No.: 001 RX (EQ 500MG BASE/5ML (EQ 100MG BASE/ML)); 002 RX (EQ 200MG BASE/2ML (EQ 100MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7265099 Use of chemical chelators as reversal agents for drug-induced neuromuscular block Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 12, 2016 | Aug 7, 2020 | U-1795: Reversal of neuromuscular blockage induced by rocuronium bromide or vecuronium bromide |
| Pat. No. RE44733 DS* DP* 6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block Claim Types: Pat. Sub. Date(s): All strengths: Jan 12, 2016 | Jan 27, 2021 | U-1794: Reversal of drug-induced neuromuscular block |
| Pat. No. 6949527 6-Mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block Claim Types: Kit; Method of use Pat. Sub. Date(s): All strengths: Jan 12, 2016 | Jan 27, 2021 | U-1795: Reversal of neuromuscular blockage induced by rocuronium bromide or vecuronium bromide |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 15, 2020 |
ANTARA (MICRONIZED) (CAPSULE) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: LUPIN ATLANTIS NDA No.: 021695 Prod. No.: 001 RX (43MG); 003 RX (130MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7863331 Pharmaceutical composition containing fenofibrate and method for the preparation thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Aug 8, 2020 | U-1106: Treating hypertriglyceridemias with reduction of food effect U-1107: Treating hypercholesterolemias with reduction of food effect |
| Pat. No. 7101574 DS* DP* Pharmaceutical composition containing fenofibrate and the preparation method Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None | Aug 20, 2020 |
CIPRODEX (SUSPENSION/DROPS) (OTIC) CIPROFLOXACIN; DEXAMETHASONE
Drug Classes: quinolone antimicrobial; corticosteroid
NDA Applicant: NOVARTIS NDA No.: 021537 Prod. No.: 001 RX (0.3%;0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6284804 Topical suspension formulations containing ciprofloxacin and dexamethasone Claim Types: Formulation Pat. Sub. Date(s): 001: None | Aug 10, 2020 | |
| Pat. No. 6359016 Topical suspension formulations containing ciprofloxacin and dexamethasone Claim Types: Formulation Pat. Sub. Date(s): 001: None | Aug 10, 2020 | |
| Pat. No. 9149486 DP* Method of treating middle ear infections Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 2, 2015 | Sep 13, 2022 | U-1578: Treatment of acute otitis media |
| Pat. No. 9345714 DP* Method of treating middle ear infections Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 6, 2016 | Sep 13, 2022 | U-1578: Treatment of acute otitis media |
| Pat. No. 9402805 DP* Method of treating middle ear infections Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2016 | Sep 13, 2022 | U-1578: Treatment of acute otitis media U-1679: Treatment of acute otitis externa |
| Pat. No. 8846650 DP* Method of treating middle ear infections Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Oct 3, 2014 | Jun 4, 2025 | U-1578: Treatment of acute otitis media |
SPY AGENT GREEN KIT (POWDER) (INTRAVENOUS, INTERSTITIAL) INDOCYANINE GREEN
Drug Classes: diagnostic dye
NDA Applicant: NOVADAQ TECH NDA No.: 211580 Prod. No.: 001 RX (25MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. |