EDARBI (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL
Drug Classes: angiotensin II receptor blocker
NDA Applicant: AZURITY      NDA No.: 200796  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL); 002 RX (EQ 80MG MEDOXOMIL)

Patents	Expiration	Patented Use
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist Claim Types: Composition; Method of use; Formulation; Process Pat. Sub. Date(s): All strengths: None	Jan 7, 2025	U-3: Treatment of hypertension
Pat. No. 7157584 DS* Benzimidazole derivative and use thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: None	May 22, 2025
Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jul 30, 2015	Mar 26, 2028

EDARBYCLOR (TABLET) (ORAL) AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Drug Classes: angiotensin II receptor blocker == thiazide-like diuretic
NDA Applicant: AZURITY      NDA No.: 202331  Prod. No.: 001 RX (EQ 40MG MEDOXOMIL;12.5MG); 002 RX (EQ 40MG MEDOXOMIL;25MG)

Patents	Expiration	Patented Use
Pat. No. 7572920 DP* Benzimidazole derivative and use as a II receptor antagonist Claim Types: Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None	Jan 7, 2025	U-3: Treatment of hypertension
Pat. No. 7157584 DS* Benzimidazole derivative and use thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jan 17, 2012; 002: None	May 22, 2025
Pat. No. 9066936 DP* Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jul 30, 2015	Mar 26, 2028
Pat. No. 9169238 DP* Solid pharmaceutical composition Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Nov 19, 2015	Feb 4, 2030
Pat. No. 9387249 Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2019	Jul 1, 2031	U-3: Treatment of hypertension

TRILIPIX (CAPSULE, DELAYED RELEASE) (ORAL) CHOLINE FENOFIBRATE [GENERIC AB]
NDA Applicant: ABBVIE      NDA No.: 022224  Prod. No.: 001 RX (EQ 45MG FENOFIBRIC ACID); 002 RX (EQ 135MG FENOFIBRIC ACID)

Patents	Expiration	Patented Use
Pat. No. 7259186 DS* Salts of fenofibric acid and pharmaceutical formulations thereof Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None	Jan 7, 2025

UZEDY (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) RISPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: TEVA      NDA No.: 213586  Prod. No.: 001 RX (50MG/0.14ML (50MG/0.14ML)); 002 RX (75MG/0.21ML (75MG/0.21ML)); 003 RX (100MG/0.28ML (100MG/0.28ML)); 004 RX (125MG/0.35ML (125MG/0.35ML)); 005 RX (150MG/0.42ML (150MG/0.42ML)); 006 RX (200MG/0.56ML (200MG/0.56ML)); 007 RX (250MG/0.7ML (250MG/0.7ML))

Patents	Expiration	Patented Use
Pat. No. 8802127 DP* Risperidone-containing PLA:PGA implants and methods of use thereof Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: May 3, 2023	Jan 12, 2025
Pat. No. 9439905 DP* Risperidone-containing implants and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 3, 2023	Jan 12, 2025	U-543: Treatment of schizophrenia
Pat. No. 9717799 DP* Drug-containing implants and methods of use thereof Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 3, 2023	Jan 12, 2025
Pat. No. 9895447 DP* Drug-containing PLA implants and methods of use thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 3, 2023	Jan 12, 2025
Pat. No. 9925268 DP* Drug-containing implants and methods of use thereof Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 3, 2023	Jan 12, 2025
Pat. No. 10736965 DP* Risperidone biodegradable implant Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 3, 2023	Jan 12, 2025
Pat. No. 8221778 DP* Drug-containing implants and methods of use thereof Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 3, 2023	Nov 12, 2027	U-543: Treatment of schizophrenia
Pat. No. 8741327 DP* Method of maintaining therapeutic risperidone levels in a PLA:PLGA implant Claim Types: Method of administration Pat. Sub. Date(s): All strengths: May 3, 2023	Nov 12, 2027	U-543: Treatment of schizophrenia
Pat. No. 9023897 DP* Biodegradable drug delivery compositions Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: May 3, 2023	Apr 5, 2033
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Apr 28, 2026

BEPREVE (SOLUTION/DROPS) (OPHTHALMIC) BEPOTASTINE BESILATE [GENERIC AT]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: BAUSCH AND LOMB INC      NDA No.: 022288  Prod. No.: 001 RX (1.5%)

Patents	Expiration	Patented Use
Pat. No. 8784789 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 22, 2014	Jan 13, 2025

ABILIFY (INJECTABLE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021866  Prod. No.: 001 DISC (9.75MG/1.3ML (7.5MG/ML))

Patents	Expiration	Patented Use
Pat. No. 7115587 DP* Aripiprazole complex formulation and method Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None	Jan 21, 2025 *PED	U-764: Treatment of schizophrenia
Pat. No. 7550445 DP* Aripiprazole complex formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: None	Jan 21, 2025 *PED

SANCUSO (FILM, EXTENDED RELEASE) (TRANSDERMAL) GRANISETRON
Drug Classes: serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: CUMBERLAND      NDA No.: 022198  Prod. No.: 001 RX (3.1MG/24HR)

Patents	Expiration	Patented Use
Pat. No. 7608282 DP* Transdermal granisetron Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None	Jan 22, 2025	U-1011: Use of granisetron transdermal system to treat/prevent chemotherapy induced nausea and vomiting

LOCOID (LOTION) (TOPICAL) HYDROCORTISONE BUTYRATE [GENERIC AB]
NDA Applicant: BAUSCH      NDA No.: 022076  Prod. No.: 001 RX (0.1%)

Patents	Expiration	Patented Use
Pat. No. 7981877 DP* Stabilized steroid composition and method for its preparation Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Aug 18, 2011	Jan 23, 2025

HORIZANT (TABLET, EXTENDED RELEASE) (ORAL) GABAPENTIN ENACARBIL
NDA Applicant: AZURITY      NDA No.: 022399  Prod. No.: 001 RX (600MG); 002 RX (300MG)

Patents	Expiration	Patented Use
Pat. No. 8686034 Crystalline form of .gamma.-aminobutyric acid analog Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 28, 2014	Jan 24, 2025	U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults U-1247: Management of postherpetic neuralgia (PHN) in adults
Pat. No. 6818787 DS* DP* [Extended 882 days (2.4 years)] Prodrugs of GABA analogs, compositions and uses thereof Claim Types: Compound Pat. Sub. Date(s): 001: Apr 19, 2011; 002: Jan 5, 2012	Apr 6, 2025
Pat. No. 8114909 Treating or preventing restless legs syndrome using prodrugs of GABA analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 13, 2012; 002: None	Apr 11, 2026	U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults
Pat. No. 8026279 DS* DP* Crystalline form of .gamma.-aminobutyric acid analog Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Oct 24, 2011; 002: Jan 5, 2012	Nov 10, 2026
Pat. No. 8795725 DP* GABA analog prodrug sustained release oral dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 27, 2014	Jun 10, 2029	U-1231: Treatment of moderate-to-severe primary restless leg syndrome in adults U-1247: Management of postherpetic neuralgia (PHN) in adults

NULIBRY (POWDER) (INTRAVENOUS) FOSDENOPTERIN HYDROBROMIDE
Drug Classes: cyclic pyranopterin monophosphate (cPMP)
NDA Applicant: SENTYNL THERAPS INC      NDA No.: 214018  Prod. No.: 001 RX (EQ 9.5MG BASE/VIAL)

Patents	Expiration	Patented Use
Pat. No. 7504095 DP* Method for obtaining precursor Z and use thereof for the production of a means for therapy of human molybdenum cofactor deficiency Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Mar 23, 2021	Jan 31, 2025	U-3092: Method of treating molybdenum cofactor deficiency type A
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Oct 27, 2025	M-286: Information added to clinical pharmacology section to include results from study ORGN001-102
Exclusivity Code: NCE - New chemical entity	Feb 26, 2026
Exclusivity Code: ODE - Orphan drug exclusivity	Feb 26, 2028	ODE-342: Indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MOCD) type A

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML))

Patents	Expiration	Patented Use
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 12, 2013	Feb 5, 2025
Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 17, 2014	Jan 8, 2027	U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min
Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2023	Jan 8, 2027	U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 4, 2022	Jan 8, 2027	U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 21, 2022	Jan 8, 2027	U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 12, 2013	Feb 15, 2028	U-1432: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	May 31, 2026	I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity
Exclusivity Code: NPP - New patient population	Nov 19, 2024

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 002 RX (500MG IRON/10ML (50MG IRON/ML))

Patents	Expiration	Patented Use
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Feb 2, 2021	Feb 5, 2025
Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Feb 2, 2021	Jan 8, 2027	U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min
Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 28, 2023	Jan 8, 2027	U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 4, 2022	Jan 8, 2027	U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 21, 2022	Jan 8, 2027	U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 2, 2021	Feb 15, 2028	U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	May 31, 2026	I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity
Exclusivity Code: NPP - New patient population	Nov 19, 2024

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 003 RX (1GM IRON/20ML (50MG IRON/ML))

Patents	Expiration	Patented Use
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 003: May 21, 2021	Feb 5, 2025
Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 003: May 21, 2021	Jan 8, 2027	U-1620: Method of treatment of iron-related conditions with at least 0.6 grams of elemental iron via an iron carbohydrate complex, with a substantially non-immunogenic carbohydrate component, in about 15 minutes or less. U-3050: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3051: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering at least about 0.6g of iron as ferric carboxymaltose in about 15 min or less U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min
Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: Jun 28, 2023	Jan 8, 2027	U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 4, 2022	Jan 8, 2027	U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: Nov 21, 2022	Jan 8, 2027	U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 003: May 21, 2021	Feb 15, 2028	U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-2556: Method of treating iron deficiency anemia in adults who have intolerance to or have had unsatisfactory response to oral iron associated with heavy uterine bleeding or a gastrointestinal disorder by intravenously administering ferric carboxymaltose U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	May 31, 2026	I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity
Exclusivity Code: NPP - New patient population	Nov 19, 2024
Exclusivity Code: NS - New strength	Apr 28, 2024

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 004 RX (100MG IRON/2ML (50MG IRON/ML))

Patents	Expiration	Patented Use
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Claim Types: Formulation; Process Pat. Sub. Date(s): 004: Mar 4, 2022	Feb 5, 2025
Pat. No. 8895612 Methods and compositions for administration of iron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 004: Mar 4, 2022	Jan 8, 2027	U-3115: Method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3116: Method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering about 1 g of iron as ferric carboxymaltose in about 15 minutes or less U-3315: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by administering IV at least about 0.6 g of iron as ferric carboxymaltose in about 15 min or less U-3316: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering at least about 0.6 grams of iron as ferric carboxymaltose in about 15 minutes or less U-3635: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY Heart Association class II/III to improve exercise capacity by administering IV ferric carboxymaltose to provide at least about 0.6 g of elemental iron in about 15 min
Pat. No. 11364260 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Jun 28, 2023	Jan 8, 2027	U-3637: Method to treat iron deficiency in adults weighing at least 40 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Pat. No. 11433091 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Oct 4, 2022	Jan 8, 2027	U-3435: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes U-3436: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 46.7 kg by intravenously administering ferric carboxymaltose to provide at least 0.7 g of elemental iron in less than 15 minutes U-3437: Method to treat IDA in adults & pediatric patients 1 year & older with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder by administering IV ferric carboxymaltose to give at least 0.7 g of iron in 15 minutes U-3438: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 46.7 kg by administering IV ferric carboxymaltose to provide at least 0.7 g of elemental iron in < 15 minutes U-3634: Method of treating ida in adult patients weighing at least 46.7 kg with heart failure & ny heart association class II/III to improve exercise capacity by administering iv ferric carboxymaltose to provide at least 0.7 g of elemental iron in 15 minutes
Pat. No. 11478502 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Nov 21, 2022	Jan 8, 2027	U-3472: Method to treat ida in adults with intolerance or unsatisfactory response to oral iron & heavy uterine bleeding or gi disorder weighing at least 40 kg by administering iv ferric carboxymaltose to give at least 0.6 g of iron in 15 minutes or less U-3473: Method to treat iron deficiency anemia in adults with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less U-3474: Method to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least 0.6 g of elemental iron in 15 minutes or less
Pat. No. 7754702 Methods and compositions for administration of iron Claim Types: Method of use Pat. Sub. Date(s): 004: Mar 4, 2022	Feb 15, 2028	U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron U-3314: Method of treating IDA in adults & pediatric patients 1 yr & older having intolerance or unsatisfactory response to oral iron associated with heavy uterine bleeding or gastrointestinal disorder by intravenously administering ferric carboxymaltose U-3636: Method to treat IDA in adults weighing at least 40 kg with heart failure & NY heart association class II/III to improve exercise capacity by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	May 31, 2026	I-915: Treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity

EPANOVA (CAPSULE) (ORAL) OMEGA-3-CARBOXYLIC ACIDS
NDA Applicant: ASTRAZENECA      NDA No.: 205060  Prod. No.: 001 DISC (1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS)

Patents	Expiration	Patented Use
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. 7960370 DP* [Extended 681 days (1.9 years)] Type A gelatin capsule containing PUFA in free acid form Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 3, 2014	Dec 20, 2026
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

KYBELLA (SOLUTION) (SUBCUTANEOUS) DEOXYCHOLIC ACID [GENERIC AP]
NDA Applicant: ABBVIE      NDA No.: 206333  Prod. No.: 001 RX (20MG/2ML (10MG/ML))

Patents	Expiration	Patented Use
Pat. No. 8846066 Methods and related compositions for reduction of fat and skin tightening Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015	Feb 8, 2025	U-1690: Method for reduction of submental fat
Pat. No. 8298556 Methods and related compositions for the non-surgical removal of fat Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015	Aug 3, 2025	U-1690: Method for reduction of submental fat
Pat. No. 7622130 Methods and compositions for the non-surgical removal of fat Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015	Dec 10, 2027	U-1690: Method for reduction of submental fat
Pat. No. 7754230 Methods and related compositions for reduction of fat Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015	Dec 10, 2027	U-1690: Method for reduction of submental fat
Pat. No. 8461140 DP* Synthetic bile acid compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	Feb 21, 2028
Pat. No. 8546367 DP* Synthetic bile acid compositions and methods Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 27, 2015	Feb 21, 2028	U-1690: Method for reduction of submental fat
Pat. No. 8883770 DP* Synthetic bile acid compositions and methods Claim Types: Composition Pat. Sub. Date(s): 001: May 27, 2015	Feb 21, 2028
Pat. No. 9522155 DP* Synthetic bile acid compositions and methods Claim Types: Composition; Method of use; Drug in a container Pat. Sub. Date(s): 001: Jan 19, 2017	Feb 21, 2028	U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling
Pat. No. 9636349 Synthetic bile acid compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 29, 2017	Feb 21, 2028	U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling
Pat. No. 9949986 Synthetic bile acid compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 001: May 24, 2018	Feb 21, 2028	U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling
Pat. No. 8242294 DS* Synthetic bile acid compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	May 16, 2028
Pat. No. 8101593 DP* Formulations of deoxycholic acid and salts thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	Mar 2, 2030
Pat. No. 8367649 DP* Formulations of deoxycholic acid and salts thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	Mar 2, 2030
Pat. No. 8653058 DP* Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	Mar 2, 2030
Pat. No. 10500214 DP* Formulations of deoxycholic acid and salts thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2020	Mar 2, 2030

ZURAGARD (SOLUTION) (TOPICAL) ISOPROPYL ALCOHOL
NDA Applicant: ZUREX PHARMA      NDA No.: 210872  Prod. No.: 001 OTC (70%)

Patents	Expiration	Patented Use
Pat. No. 9011897 DP* Catheter lock solution comprising citrate and a paraben Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 12, 2021	Feb 8, 2025
Pat. No. 8226971 DP* Catheter lock solution comprising citrate and a paraben Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 12, 2021	May 6, 2025
Pat. No. 8703828 DP* Antimicrobial compositions and methods of use Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Jul 12, 2021	May 23, 2028
Pat. No. 9629368 Antimicrobial compositions and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 12, 2021	May 23, 2028	U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery
Pat. No. 8389583 Antimicrobial compositions and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 12, 2021	Aug 9, 2029	U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery
Pat. No. 10688291 DP* Medical skin applicator apparatus Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jul 12, 2021	Dec 20, 2034	U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery
Pat. No. 9844654 DP* Medical skin applicator apparatus Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jul 12, 2021	Apr 24, 2036	U-1397: Use as an antiseptic for the preparation of a patient's skin prior to surgery
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Jun 24, 2024	M-268: Addition of information to the label regarding a clear product presentation and 26 ml volume products

DUAKLIR PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE
Drug Classes: anticholinergic == beta-2 adrenergic agonist
NDA Applicant: COVIS      NDA No.: 210595  Prod. No.: 001 RX (0.4MG/INH;0.012MG/INH)

Patents	Expiration	Patented Use
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)
Pat. No. 11000517 DP* Dosage and formulation Claim Types: Composition; Formulation; Method of use; Device Pat. Sub. Date(s): 001: Jun 10, 2021	Mar 13, 2029	U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)

TUDORZA PRESSAIR (POWDER, METERED) (INHALATION) ACLIDINIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: COVIS      NDA No.: 202450  Prod. No.: 001 RX (0.4MG/INH)

Patents	Expiration	Patented Use
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)
Pat. No. 11000517 DP* Dosage and formulation Claim Types: Composition; Formulation; Method of use; Device Pat. Sub. Date(s): 001: Jun 10, 2021	Mar 13, 2029	U-2513: Maintenance treatment of chronic obstructive pulmonary disease (COPD)

SCENESSE (IMPLANT) (SUBCUTANEOUS) AFAMELANOTIDE
NDA Applicant: CLIVUNEL INC      NDA No.: 210797  Prod. No.: 001 RX (16MG)

Patents	Expiration	Patented Use
Pat. No. 10076555 Methods of inducing melanogenesis in a subject Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 6, 2019	Feb 11, 2025	U-2638: Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
Pat. No. 8334265 [Extended 1411 days (3.9 years)] Method of treatment of photodermatoses Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 6, 2019	Mar 11, 2029	U-2638: Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Oct 8, 2024
Exclusivity Code: ODE - Orphan drug exclusivity	Oct 8, 2026	ODE-270: Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)

HYSINGLA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [GENERIC AB]
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 206627  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG); 004 RX (60MG); 005 RX (80MG); 006 RX (100MG); 007 RX (120MG)

Patents	Expiration	Patented Use
Pat. No. 11844865 DP* Abuse-proofed oral dosage form Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Dec 22, 2023	Feb 13, 2025	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. 9084816 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 21, 2015	Aug 24, 2027
Pat. No. 9095614 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2015	Aug 24, 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. 9095615 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 4, 2015	Aug 24, 2027
Pat. No. 9486412 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 8, 2016	Aug 24, 2027
Pat. No. 9486413 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 8, 2016	Aug 24, 2027
Pat. No. 9492389 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Nov 16, 2016	Aug 24, 2027
Pat. No. 9492390 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2016	Aug 24, 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. 9492391 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2016	Aug 24, 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. 9545380 Tamper resistant dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 17, 2017	Aug 24, 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. 9763933 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 19, 2017	Aug 24, 2027
Pat. No. 9770416 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 27, 2017	Aug 24, 2027
Pat. No. 9775809 DP* Tamper resistant dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 4, 2017	Aug 24, 2027
Pat. No. 11304908 DP* Tamper resistant dosage forms Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022	Aug 24, 2027
Pat. No. 11304909 Tamper resistant dosage forms Claim Types: Method of use of a product-by-process Pat. Sub. Date(s): All strengths: Apr 21, 2022	Aug 24, 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. 8808740 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 21, 2014	Dec 21, 2031	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. 9572779 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 21, 2017	Dec 21, 2031
Pat. No. 9750703 DP* Encased tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 14, 2017	Dec 21, 2031
Pat. No. 9861584 DP* Tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 10, 2018	Dec 21, 2031
Pat. No. 9872837 DP* Tamper resistant controlled release dosage forms Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 23, 2018	Dec 21, 2031

IZERVAY (SOLUTION) (INTRAVITREAL) AVACINCAPTAD PEGOL SODIUM
NDA Applicant: ASTELLAS      NDA No.: 217225  Prod. No.: 001 RX (EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML))

Patents	Expiration	Patented Use
Pat. No. 7538211 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Compound Pat. Sub. Date(s): 001: Aug 31, 2023	Feb 14, 2025
Pat. No. 7579456 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Composition Pat. Sub. Date(s): 001: Aug 31, 2023	Feb 14, 2025
Pat. No. 7803931 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 31, 2023	Feb 14, 2025
Pat. No. 9617546 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Aug 31, 2023	Feb 14, 2025	U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 10947544 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 31, 2023	Feb 14, 2025	U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 8236773 Aptamer therapeutics useful in the treatment of complement-related disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 31, 2023	Nov 11, 2026	U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 11273171 Methods for treating or preventing ophthalmological conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 31, 2023	Jul 11, 2034	U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Pat. No. 11491176 Methods for treating or preventing ophthalmological conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 31, 2023	Jul 11, 2034	U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye

INTERMEZZO (TABLET) (SUBLINGUAL) ZOLPIDEM TARTRATE [Has competitive generic]
Drug Classes: gamma-aminobutyric acid (GABA) A receptor positive modulator
NDA Applicant: PURDUE PHARMA      NDA No.: 022328  Prod. No.: 001 DISC (1.75MG); 002 DISC (3.5MG)

Patents	Expiration	Patented Use
Pat. No. 7682628 Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 29, 2011; 002: None	Feb 16, 2025	U-1194: Method for treating insomnia
Pat. No. 8252809 DP* Compositions for treating insomnia Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 28, 2012; 002: None	Feb 16, 2025
Pat. No. 7658945 DP* Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Nov 29, 2011; 002: None	Apr 15, 2027	U-1194: Method for treating insomnia
Pat. No. 8242131 Methods of treating middle-of-the-night insomnia Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 15, 2012; 002: None	Aug 20, 2029	U-1266: Method of treating middle-of-the-night insomnia

IXEMPRA KIT (INJECTABLE) (INTRAVENOUS) IXABEPILONE
Drug Classes: microtubule inhibitor
NDA Applicant: R-PHARM US LLC      NDA No.: 022065  Prod. No.: 001 RX (15MG/VIAL); 002 RX (45MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 7312237 Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: None	Feb 21, 2025 *PED	U-965: Use of ixabepilone in combination with capecitabine in treatment of metastasis breast cancer

ARCAPTA NEOHALER (POWDER) (INHALATION) INDACATEROL MALEATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: NOVARTIS      NDA No.: 022383  Prod. No.: 001 DISC (EQ 75MCG BASE)

Patents	Expiration	Patented Use
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

INCIVEK (TABLET) (ORAL) TELAPREVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor
NDA Applicant: VERTEX PHARMS      NDA No.: 201917  Prod. No.: 001 DISC (375MG)

Patents	Expiration	Patented Use
Pat. No. 7820671 DS* DP* [Extended 87 days (0.2 years)] Peptidomimetic protease inhibitors Claim Types: Compound; Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jun 20, 2011	Feb 25, 2025
Pat. No. 8431615 Dose forms Claim Types: Method of administration Pat. Sub. Date(s): 001: May 29, 2013	May 30, 2028	U-1398: Method of treating chronic hepatitis C

RUKOBIA (TABLET, EXTENDED RELEASE) (ORAL) FOSTEMSAVIR TROMETHAMINE
NDA Applicant: VIIV HLTHCARE      NDA No.: 212950  Prod. No.: 001 RX (EQ 600MG BASE)

Patents	Expiration	Patented Use
Pat. No. 8461333 DS* Salts of prodrugs of piperazine and substituted piperidine antiviral agents Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 17, 2020	Feb 25, 2025
Pat. No. 7745625 DS* Prodrugs of piperazine and substituted piperidine antiviral agents Claim Types: Compound; Process Pat. Sub. Date(s): 001: Jul 17, 2020	Nov 19, 2027
Pat. No. 8168615 DP* Prodrugs of piperazine and substituted piperidine antiviral agents Claim Types: Composition Pat. Sub. Date(s): 001: Jul 17, 2020	Jul 13, 2029
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 2, 2025

UTIBRON (POWDER) (INHALATION) GLYCOPYRROLATE; INDACATEROL MALEATE
Drug Classes: anticholinergic == antimuscarinic agent == beta-2 adrenergic agonist
NDA Applicant: NOVARTIS      NDA No.: 207930  Prod. No.: 001 DISC (15.6MCG/INH;27.5MCG/INH)

Patents	Expiration	Patented Use
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

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-1 protease inhibitor
NDA Applicant: ABBVIE      NDA No.: 207931  Prod. No.: 001 DISC (12.5MG;75MG;50MG**)

Patents	Expiration	Patented Use
Pat. No. 8268349 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015	Feb 25, 2025 *PED
Pat. No. 8399015 DP* Solid pharmaceutical dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 6, 2015	Feb 25, 2025 *PED
Pat. No. 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

SPIRIVA RESPIMAT (SPRAY, METERED) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021936  Prod. No.: 001 RX (EQ 0.0025MG BASE/INH); 002 RX (EQ 0.00125MG BASE/INH)

Patents	Expiration	Patented Use
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015	Feb 26, 2025 *PED
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015	Nov 26, 2025 *PED
Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015	Apr 10, 2027 *PED
Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015	Oct 1, 2027 *PED
Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015	Sep 13, 2028 *PED
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015	Apr 16, 2031 *PED

STIOLTO RESPIMAT (SPRAY, METERED) (INHALATION) OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist == anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 206756  Prod. No.: 001 RX (EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH)

Patents	Expiration	Patented Use
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Claim Types: Device Pat. Sub. Date(s): 001: Jun 10, 2015	Feb 26, 2025 *PED
Pat. No. 7220742 DS* DP* Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jun 10, 2015	May 12, 2025	U-1703: Treatment of respiratory complaints
Pat. No. 8034809 Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 10, 2015	May 12, 2025	U-1702: Treatment of copd
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Claim Types: Device; Process Pat. Sub. Date(s): 001: Jun 10, 2015	May 26, 2025
Pat. No. 7727984 DS* Medicaments for the treatment of chronic obstructive pulmonary disease Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jun 10, 2015	Jan 19, 2027
Pat. No. 9027967 DP* Device for clamping a fluidic component Claim Types: Device; Process Pat. Sub. Date(s): 001: Jun 10, 2015	Mar 31, 2027
Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 10, 2015	Apr 10, 2027 *PED
Pat. No. 7837235 DP* Device for clamping a fluidic component Claim Types: Device Pat. Sub. Date(s): 001: Jun 10, 2015	Sep 13, 2028 *PED
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jun 10, 2015	Oct 16, 2030

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 022406  Prod. No.: 001 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)] Substituted oxazolidinones and their use in the field of blood coagulation Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 001: Aug 4, 2011	Feb 28, 2025 *PED	U-1301: Treatment of deep vein thrombosis (DVT) U-1302: Treatment of pulmonary embolism (PE)
Pat. No. 9415053 DP* Solid, orally administrable pharmaceutical composition Claim Types: Product-by-process; Process; Method of use Pat. Sub. Date(s): 001: Sep 14, 2016	May 13, 2025 *PED	U-1167: Prophylaxis of deep vein thrombosis (DVT) U-2142: Reduction in the risk of recurrence of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients at continued risk for recurrent DVT and/or after completion of initial treatment lasting at least 6 months U-2640: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding U-3284: Prophylaxis of thromboembolic diseases in pediatric patients aged 2 years and older with congenital heart disease who have undergone the fontan procedure and a body weight of >=50 kg
Pat. No. 9539218 Prevention and treatment of thromboembolic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 7, 2017	Aug 17, 2034 *PED	U-1957: Prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery, with once daily, rapid-release tablet administered for at least five consecutive days U-2143: After completion of initial treatment lasting at least 6 months, to reduce the risk of recurrence of deep vein thrombosis and/or pulmonary embolism in certain patients with once daily, rapid-release tablet administered for at least 5 consecutive days U-2641: Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding with once daily, rapid-release tablet administered for at least 5 consecutive days U-3288: Prophylaxis of PE, DVT and/or stroke in pediatric patients (>=50 kg) aged 2 years and older with congenital heart disease after fontan procedure with once daily, rapid-release tablet administered for at least 5 consecutive days
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Feb 23, 2025 PED	I-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 022406  Prod. No.: 002 RX (15MG)

Patents	Expiration	Patented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)] Substituted oxazolidinones and their use in the field of blood coagulation Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 002: Dec 2, 2011	Feb 28, 2025 *PED	U-1301: Treatment of deep vein thrombosis (DVT) U-1302: Treatment of pulmonary embolism (PE)
Pat. No. 9415053 DP* Solid, orally administrable pharmaceutical composition Claim Types: Product-by-process; Process; Method of use Pat. Sub. Date(s): 002: Sep 14, 2016	May 13, 2025 *PED	U-1200: Reducing the risk of stroke and systemic embolism U-1301: Treatment of deep vein thrombosis (DVT) U-1302: Treatment of pulmonary embolism (PE) U-3286: Treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years with a body weight of 30 kg to 49.9 kg after at least 5 days of initial parenteral anticoagulant treatment
Pat. No. 9539218 Prevention and treatment of thromboembolic disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 7, 2017	Aug 17, 2034 *PED	U-1953: Reduce the risk of stroke in patients with nonvalvular atrial fibrillation with once daily, rapid-release tablet administered for at least five consecutive days U-3289: Treatment of DVT and/or PE and reduction in risk of recurrent DVT and/or PE in pediatric patients (30-49.9 kg) once daily with rapid-release tablet administered for at least 5 consecutive days after at least 5 days parenteral anticoagulant treatment
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Feb 23, 2025 PED	I-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 022406  Prod. No.: 003 RX (20MG)

Patents	Expiration	Patented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)] Substituted oxazolidinones and their use in the field of blood coagulation Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 003: Dec 2, 2011	Feb 28, 2025 *PED	U-1301: Treatment of deep vein thrombosis (DVT) U-1302: Treatment of pulmonary embolism (PE)
Pat. No. 9415053 DP* Solid, orally administrable pharmaceutical composition Claim Types: Product-by-process; Process; Method of use Pat. Sub. Date(s): 003: Sep 14, 2016	May 13, 2025 *PED	U-1200: Reducing the risk of stroke and systemic embolism U-1301: Treatment of deep vein thrombosis (DVT) U-1302: Treatment of pulmonary embolism (PE) U-3287: Treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years with a body weight of >=50 kg after at least 5 days of initial parenteral anticoagulant treatment
Pat. No. 9539218 Prevention and treatment of thromboembolic disorders Claim Types: Method of use Pat. Sub. Date(s): 003: Feb 7, 2017	Aug 17, 2034 *PED	U-1953: Reduce the risk of stroke in patients with nonvalvular atrial fibrillation with once daily, rapid-release tablet administered for at least five consecutive days U-1954: Treatment of deep vein thrombosis with once daily, rapid-release tablet administered for at least five consecutive days U-1955: Treatment of pulmonary embolism with once daily, rapid-release tablet administered for at least five consecutive days U-3285: Treatment of DVT and/or PE and reduction in the risk of recurrent DVT and/or PE in pediatric patients (>=50 kg) once daily with rapid-release tablet administered for at least 5 consecutive days after at least 5 days parenteral anticoagulant treatment
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Feb 23, 2025 PED	I-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

XARELTO (TABLET) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 022406  Prod. No.: 004 RX (2.5MG)

Patents	Expiration	Patented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)] Substituted oxazolidinones and their use in the field of blood coagulation Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 004: Nov 8, 2018	Feb 28, 2025 *PED
Pat. No. 9415053 DP* Solid, orally administrable pharmaceutical composition Claim Types: Product-by-process; Process; Method of use Pat. Sub. Date(s): 004: Nov 8, 2018	May 13, 2025 *PED	U-2435: Reduction of risk of major cardiovascular events (CV death, MI, and stroke) in chronic CAD or PAD U-3205: Reduction of risk of major cardiovascular events (cardiovascular death, myocardial infarction and stroke) in patients with CAD U-3206: Reduction of risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD
Pat. No. 10828310 Reducing the risk of cardiovascular events Claim Types: Method of use Pat. Sub. Date(s): 004: Dec 9, 2020	Jul 31, 2039 *PED	U-3207: Reduction of risk of cardiovascular death, myocardial infarction, and stroke in patients with CAD by administering clinically proven effective amounts that are 2.5 mg rivaroxaban twice daily and 75-100 mg aspirin daily U-3208: Reduction of risk of myocardial infarction and ischemic stroke in patients with PAD by administering clinically proven effective amounts that are 2.5 mg rivaroxaban twice daily and 75-100 mg aspirin daily
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Feb 23, 2025 PED	I-867: Indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

XARELTO (FOR SUSPENSION) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 215859  Prod. No.: 001 RX (1MG/ML)

Patents	Expiration	Patented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)] Substituted oxazolidinones and their use in the field of blood coagulation Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 001: Jan 18, 2022	Feb 28, 2025 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Jun 20, 2025 PED

XALKORI (CAPSULE) (ORAL) CRIZOTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 202570  Prod. No.: 001 RX (200MG); 002 RX (250MG)

Patents	Expiration	Patented Use
Pat. No. 8785632 DS* Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: None	Mar 1, 2025
Pat. No. 7230098 DS* [Extended 178 days (0.5 years)] Aminoheteroaryl compounds as protein kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: Sep 14, 2011	Aug 26, 2025
Pat. No. 7825137 Method of treating abnormal cell growth Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2011; 002: None	May 12, 2027	U-3057: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive U-3058: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive U-3403: Method of reversing or inhibiting the progress of unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive in adult and pediatric patients 1 year of age and older
Pat. No. 7858643 DS* DP* Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 14, 2011; 002: None	Oct 8, 2029
Pat. No. 8217057 DS* DP* Polymorphs of a c-MET/HGFR inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Jul 31, 2012; 002: None	Nov 6, 2029
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jan 14, 2024	I-852: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive
Exclusivity Code: I - New Indication	Jul 14, 2025	I-897: Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent or refractory inflammatory myofibroblastic tumor (IMT) that is anaplastic lymphoma kinase (ALK) positive
Exclusivity Code: ODE - Orphan drug exclusivity	Jan 14, 2028	ODE-328: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive
Exclusivity Code: ODE - Orphan drug exclusivity	Jul 14, 2029	ODE-407: Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive

XALKORI (CAPSULE, PELLETS) (ORAL) CRIZOTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 217581  Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (150MG)

Patents	Expiration	Patented Use
Pat. No. 8785632 DS* DP* Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: Oct 6, 2023	Mar 1, 2025
Pat. No. 7230098 DS* [Extended 178 days (0.5 years)] Aminoheteroaryl compounds as protein kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: Oct 6, 2023	Aug 26, 2025
Pat. No. 7825137 Method of treating abnormal cell growth Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 6, 2023	May 12, 2027	U-3057: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive U-3058: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive U-3403: Method of reversing or inhibiting the progress of unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive in adult and pediatric patients 1 year of age and older
Pat. No. 7858643 DS* DP* Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Oct 6, 2023	Oct 8, 2029
Pat. No. 8217057 DS* Polymorphs of a c-MET/HGFR inhibitor Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): All strengths: Oct 6, 2023	Nov 6, 2029
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jan 14, 2024	I-852: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive
Exclusivity Code: I - New Indication	Jul 14, 2025	I-897: Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent or refractory inflammatory myofibroblastic tumor (IMT) that is anaplastic lymphoma kinase (ALK) positive

AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 004 RX (0.055MG/INH;EQ 0.014MG BASE/INH)

Patents	Expiration	Patented Use
Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 004: Aug 2, 2019	Mar 1, 2025 *PED
Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): 004: Aug 2, 2019	Mar 1, 2025 *PED
Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Nov 19, 2025 *PED
Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2020	Nov 19, 2025 *PED
Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Sep 26, 2028 *PED
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Aug 2, 2019	Aug 14, 2031 *PED
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Nov 18, 2031 *PED
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Nov 18, 2031 *PED
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Aug 2, 2019	Nov 18, 2031 *PED
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Dec 28, 2031 *PED
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 004: Mar 19, 2020	Jul 1, 2032 *PED
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Jul 13, 2032 *PED
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Aug 25, 2032 *PED
Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019	Apr 6, 2035 *PED	U-645: Treatment of asthma
Pat. No. 9415008 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019	Apr 6, 2035 *PED	U-645: Treatment of asthma
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Aug 2, 2019	Feb 28, 2036 *PED
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019	Feb 28, 2036 *PED
Pat. No. 10918816 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 18, 2021	Jun 14, 2036 *PED
Pat. No. 10569034 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 12, 2020	Feb 16, 2037 *PED
Pat. No. 11351317 DP* Drug delivery device with electronics Claim Types: Device; Method of detecting usage condition of a device; Part of a dosage form Pat. Sub. Date(s): 004: Jun 29, 2022	Aug 10, 2038 *PED
Pat. No. 11357935 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Jul 13, 2022	Sep 24, 2038
Pat. No. 11000653 DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 004: Jun 10, 2021	Jun 18, 2039 *PED
Pat. No. 11344685 DP* Drug delivery device with electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Jun 29, 2022	Mar 26, 2040 *PED
Pat. No. 11439777 DP* Drug delivery device with electronics Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2022	May 24, 2040
Pat. No. 11464923 DP* Inhaler system Claim Types: Device; Method of improving a treatment Pat. Sub. Date(s): 004: Nov 10, 2022	Jun 19, 2040
Pat. No. 11173259 DP* Drug delivery device with electronics and power management Claim Types: Device Pat. Sub. Date(s): 004: Dec 8, 2021	Jan 6, 2041 *PED
Pat. No. 11266796 DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Apr 7, 2022	Aug 22, 2041 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Jan 9, 2025 PED	M-61: Revisions to labeling based on data submitted in response to pediatric written request

AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX (0.232MG/INH;EQ 0.014MG BASE/INH)

Patents	Expiration	Patented Use
Pat. No. 9616024 DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Mar 1, 2025 *PED
Pat. No. 9987229 DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 2, 2019	Mar 1, 2025 *PED
Pat. No. 9463288 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Nov 19, 2025 *PED
Pat. No. 10765820 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020	Nov 19, 2025 *PED
Pat. No. 8651103 DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Sep 26, 2028 *PED
Pat. No. 10195375 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Aug 14, 2031 *PED
Pat. No. 9731087 DP* Dose counter for inhaler having a bore and shaft arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Nov 18, 2031 *PED
Pat. No. 10022510 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Nov 18, 2031 *PED
Pat. No. 10124131 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Nov 18, 2031 *PED
Pat. No. 9216260 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Dec 28, 2031 *PED
Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020	Jul 1, 2032 *PED
Pat. No. 8978966 DP* Dose counters for inhalers, inhalers and methods of assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Jul 13, 2032 *PED
Pat. No. 8714149 DP* Airflow adaptor for a breath-actuated dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Aug 25, 2032 *PED
Pat. No. 9066957 DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2019	Apr 6, 2035 *PED	U-645: Treatment of asthma
Pat. No. 9782550 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Aug 2, 2019	Feb 28, 2036 *PED
Pat. No. 9782551 DP* Compliance monitoring module for a breath-actuated inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019	Feb 28, 2036 *PED
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