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

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-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-2591: Lowering plasma glucagon in adults with Type 2 diabetes mellitus by administering exenatide as an adjunct to diet and exercise
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-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 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-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: Nov 17, 2017	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: Nov 17, 2017	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: 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-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-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* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None	Apr 13, 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. 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-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-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* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 10, 2013	Apr 13, 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-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* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None	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 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-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 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2015	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
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-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. 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-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: Nov 17, 2017	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
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 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* 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* 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* 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* 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* 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 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 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 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* 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-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-2591: Lowering plasma glucagon in adults with Type 2 diabetes mellitus by administering exenatide as an adjunct to diet and exercise
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-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 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-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): 002: Nov 15, 2017	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): 002: Nov 15, 2017	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): 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-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-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* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014	Apr 13, 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. 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-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-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* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014	Apr 13, 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-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* Polymer-based sustained release device Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Mar 28, 2014	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 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-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 Method for treating diabetes Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 6, 2015	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
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-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. 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-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. 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. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 15, 2017	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. 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. 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. 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
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

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: Treatement [sic, 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: Treatement [sic, 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. 9566286 DP* Pharmaceutical spray composition comprising a vitamin D analogue and a corticosteroid Claim Types: Device Pat. Sub. Date(s): 001: Nov 15, 2019	Jun 10, 2031
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. 9700537 Composition for preventing the occurrence of cardiovascular event in multiple risk patient Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 10, 2020	May 31, 2027	U-2707: Use of VASCEPA as an adjunct to statin therapy to reduce the occurrence of a cardiovascular event in an adult patient with hypercholesterolemia
Pat. No. 9198892 Composition and/or method for preventing onset and/or recurrence of cardiovascular events Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jan 10, 2020	Sep 25, 2027	U-2706: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of onset and/or recurrence of cardiovascular events in a patient who has escaped the unstable period after cardiovascular angioplasty
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. 8518929 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. 8524698 Methods of treating hypertriglyceridemia Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 11, 2013	Feb 9, 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	Feb 9, 2030	U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8680144 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Feb 9, 2030	U-2695: Use of VASCEPA to treat mixed hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
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. 8454994 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Apr 29, 2030	U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 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. 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 U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
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. 8618166 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Apr 29, 2030	U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 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 U-2692: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8642077 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Apr 29, 2030	U-2693: Use of VASCEPA to reduce triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8691871 Methods of treating mixed dyslipidemia Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Apr 29, 2030	U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8703185 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Apr 29, 2030	U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8709475 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Apr 29, 2030	U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 10010517 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Apr 29, 2030	U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 10265287 Methods of reducing triglycerides and LDL-C Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Apr 29, 2030	U-2700: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on rosuvastatin therapy
Pat. No. 8410086 Compositions and methods for lowering triglycerides Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 15, 2030	U-2688: Use of VASCEPA to lower triglycerides and ldl-c in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 8455472 Compositions and 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: Jan 6, 2020	Jun 15, 2030	U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 8669245 Compositions and 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: Jan 6, 2020	Jun 15, 2030	U-2694: Use of VASCEPA to lower triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 8710041 Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 15, 2030	U-2690: Use of VASCEPA to lower triglycerides in an adult patient with elevated triglyceride (TG) levels (about 200 mg/dl to less than about 500 mg/dl) and on statin therapy
Pat. No. 9603826 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9610272 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9623001 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9693984 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2697: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9693985 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2696: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death, coronary revascularization, and unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9693986 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2698: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death and/or coronary revascularization in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 9918954 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2699: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels
Pat. No. 10278935 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2701: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of coronary revascularization and/or unstable angina in an adult patient with elevated triglyceride levels (TG >= 150 mg/dl to about 500 mg/dl)
Pat. No. 10278936 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2702: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event (cardiovascular death, coronary revascularization and/or unstable angina) in an adult patient with elevated triglyceride levels
Pat. No. 10278937 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2703: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cv event (cv death, coronary revascularization, unstable angina, stroke and/or myocardial infarction) in an adult patient with elevated triglyceride levels and diabetes mellitus
Pat. No. 10383840 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020	Jun 28, 2033	U-2704: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a cardiovascular event in an adult patient with elevated triglyceride levels and at least one risk factor for cardiovascular disease
Pat. No. 10555924 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 26, 2020	Jun 28, 2033	U-2743: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of unstable angina in an adult patient with established cardiovascular disease
Pat. No. 10555925 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 26, 2020	Jun 28, 2033	U-2744: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with established cardiovascular disease
Pat. No. 10568861 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 20, 2020	Jun 28, 2033	U-2756: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death in an adult patient with established cardiovascular disease
Pat. No. 10576054 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 27, 2020	Jun 28, 2033	U-2762: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of a major cardiovascular event in an adult patient with diabetes mellitus and two or more additional risk factors for cardiovascular disease
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Dec 13, 2022	I-819: Adjunct to max tolerated statin tx to reduce risk of MI, stroke, coronary revascularization, & unstable angina requiring hospitalization in adults w/ elevated TG levels & established CV disease or diabetes mellitus & 2+ risk factors for CV disease