adenosine triphosphate-citrate lyase (ACL) inhibitor
NEXLIZET (TABLET) (ORAL) BEMPEDOIC ACID; EZETIMIBE
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == adenosine triphosphate-citrate lyase (ACL) inhibitor == Cardiovascular Agents:Cardiovascular Combinations
NDA Applicant: ESPERION THERAPS INC      NDA No.: 211617  Prod. No.: 001 RX (180MG;10MG)

Patents	Expiration	Patented Use
Pat. No. 7335799 DS* Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 6, 2020	Dec 3, 2025
Pat. No. 8497301 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020	Dec 23, 2023	U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Pat. No. 9000041 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020	Dec 23, 2023	U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Pat. No. 9624152 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020	Dec 23, 2023	U-2749: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy for inhibiting cholesterol synthesis to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Pat. No. 10118881 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020	Dec 23, 2023	U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Pat. No. 10912751 Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2021	Mar 14, 2036	U-3224: A method of treating heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease by decreasing the level of LDL-C using a fixed dose combination of 180 mg bempedoic acid and 10 mg ezetimibe
Pat. No. 10941095 Hydroxyl compounds and compositions for cholesterol management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 31, 2021	Dec 23, 2023	U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
Pat. No. 11613511 DS* Methods of making bempedoic acid and compositions of the same Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 20, 2023	Jun 19, 2040
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Feb 21, 2025
Exclusivity Code: NP - New product	Feb 26, 2023

alkylating drug
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ACROTECH BIOPHARMA      NDA No.: 207155  Prod. No.: 001 RX (EQ 50MG BASE/VIAL)

Patents	Expiration	Patented Use
Pat. No. 8410077 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Compound; Product-by-process; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016	Mar 13, 2029
Pat. No. 9200088 DP* Sulfoalkyl ether cyclodextrin compositions Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Apr 5, 2016	Mar 13, 2029
Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Formulation; Product-by-process; Process Pat. Sub. Date(s): 001: Mar 14, 2017	Feb 27, 2033
Pat. No. 10040872 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 6, 2018	Jan 30, 2034
Pat. No. 10864183 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 15, 2020	May 28, 2030
Pat. No. 10940128 DP* Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Mar 19, 2021	Jun 14, 2030	U-3086: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma
Pat. No. 11020363 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 10, 2021	May 28, 2030
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity	Mar 10, 2023	ODE-110: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma

alkylating drug
PEPAXTO (POWDER) (INTRAVENOUS) MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ONCOPEPTIDES AB      NDA No.: 214383  Prod. No.: 001 DISC (EQ 20MG BASE/VIAL)

Patents	Expiration	Patented Use
Pat. No. 6992207 DS* DP* Melphalan derivatives and their use as cancer chemotherapeutic drugs Claim Types: Compound; Process; Composition; Method of use Pat. Sub. Date(s): 001: Mar 24, 2021	Jun 25, 2023	U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy
Pat. No. 10285946 DP* Lyophilized preparations of melphalan flufenamide Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Mar 24, 2021	Apr 25, 2032
Pat. No. 10322182 DP* Lyophilized preparation of cytotoxic dipeptides Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 24, 2021	Apr 25, 2032
Pat. No. 10543274 Lyophilized preparation of cytotoxic dipeptides Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2021	Apr 25, 2032	U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy
Pat. No. 10869928 DP* Lyophilized preparation of cytotoxic dipeptides Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 24, 2021	Apr 25, 2032
Pat. No. 11344622 Lyophilized preparation of cytotoxic dipeptides Claim Types: Method of using a product-by-process Pat. Sub. Date(s): 001: Jun 17, 2022	Apr 25, 2032	U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Feb 26, 2026
Exclusivity Code: ODE - Orphan drug exclusivity	Feb 26, 2028	ODE-348: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ABBVIE      NDA No.: 021528  Prod. No.: 001 RX (0.4%)

Patents	Expiration	Patented Use
Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 23, 2011	Nov 24, 2027 *PED	U-1181: A method of treating or preventing ocular pain in a patient
Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2012	Nov 28, 2024 *PED	U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient
Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 18, 2013	Nov 28, 2024 *PED	U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery
Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2013	Nov 28, 2024 *PED	U-1441: A method of treating or reducing ocular pain and burning/stinging
Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2014	May 28, 2024
Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2015	May 28, 2024	U-1626: A method of treating or preventing ocular pain and burning
Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 4, 2015	May 28, 2024	U-1662: A method of treating ocular pain
Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2016	May 28, 2024	U-1800: A method of treating ocular pain and/or enhancing ocular comfort

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ABBVIE      NDA No.: 022427  Prod. No.: 001 RX (0.45%)

Patents	Expiration	Patented Use
Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 30, 2010	Aug 15, 2029
Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 19, 2013	Mar 7, 2028
Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 10, 2015	Aug 5, 2024
Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2015	Mar 7, 2028

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL ALLERGY SINUS (TABLET) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021441  Prod. No.: 001 OTC (2MG;200MG;30MG)

Patents	Expiration	Patented Use
Pat. No. 7863287 DP* Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines Claim Types: Formulation Pat. Sub. Date(s): 001: May 6, 2011	Feb 28, 2027

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021587  Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)

Patents	Expiration	Patented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 24, 2019	May 25, 2024

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL DUAL ACTION WITH ACETAMINOPHEN (TABLET) (ORAL) ACETAMINOPHEN; IBUPROFEN [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 211733  Prod. No.: 001 OTC (250MG;125MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Feb 28, 2023

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL, CHILDREN'S FLAVORED (SUSPENSION) (ORAL) IBUPROFEN [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020589  Prod. No.: 002 OTC (100MG/5ML)

Patents	Expiration	Patented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition Claim Types: Formulation Pat. Sub. Date(s): 002: Apr 24, 2019	May 25, 2024

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BAUDAX      NDA No.: 210583  Prod. No.: 001 DISC (30MG/ML (30MG/ML))

Patents	Expiration	Patented Use
Pat. No. 9974746 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 6, 2020	May 26, 2030
Pat. No. 10463673 DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Mar 6, 2020	Feb 24, 2024	U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10471067 DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Mar 6, 2020	Feb 24, 2024	U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10709713 Nanoparticulate meloxicam formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2020	May 26, 2030	U-2750: Management of moderate-to-severe pain by intravenous injection
Pat. No. 10881663 Method of treating pain in elderly patients with mild renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2021	Mar 8, 2039	U-3038: Management of moderate-to-severe pain by intravenous injection in patients with mild renal impairment
Pat. No. 11253478 DP* Reduction of flake-like aggregation in nanoparticulate active agent compositions Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Mar 4, 2022	May 26, 2030	U-3318: Management of moderate-to-severe pain by injection
Pat. No. 11458145 Methods of administering intravenous meloxicam in a bolus dose Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2022	Mar 8, 2039	U-3318: Management of moderate-to-severe pain by injection
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Feb 20, 2023

Analgesics:Nonsteroidal Anti-inflammatory Drugs
CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 022348  Prod. No.: 001 DISC (400MG/4ML (100MG/ML))

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Nov 19, 2024	M-128: Clinical trial study results

Analgesics:Nonsteroidal Anti-inflammatory Drugs
CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 022348  Prod. No.: 002 RX (800MG/8ML (100MG/ML))

Patents	Expiration	Patented Use
Pat. No. 8735452 Treating patients with intravenous ibuprofen Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Jun 4, 2014	Sep 30, 2029	U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity
Pat. No. 8871810 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 002: Nov 12, 2014	Sep 30, 2029	U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity
Pat. No. 9012508 Administration of intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 002: May 4, 2015	Sep 14, 2030	U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity
Pat. No. 9114068 Treating patients with intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 18, 2015	Sep 30, 2029	U-1735: Methods of treating pain, inflammation and/or fever with intravenous ibuprofen such that mean arterial blood pressure does not increase the dosage interval
Pat. No. 9138404 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of administration Pat. Sub. Date(s): 002: Oct 27, 2015	Sep 30, 2029	U-1756: Methods of treating pain, inflammation and/or fever in a critically ill patient with intravenous ibuprofen in need thereof
Pat. No. 9295639 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 002: May 2, 2016	Sep 30, 2029	U-1756: Methods of treating pain, inflammation and/or fever in a critically ill patient with intravenous ibuprofen in need thereof
Pat. No. 9649284 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of administration Pat. Sub. Date(s): 002: Jun 9, 2017	Sep 30, 2029	U-2018: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics in a critically ill patient with intravenous ibuprofen in need thereof
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Nov 19, 2024	M-128: Clinical trial study results

Analgesics:Nonsteroidal Anti-inflammatory Drugs
CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 022348  Prod. No.: 003 RX (800MG/200ML (4MG/ML))

Patents	Expiration	Patented Use
Pat. No. 8735452 Treating patients with intravenous ibuprofen Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 003: Sep 23, 2019	Sep 30, 2029	U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity
Pat. No. 8871810 Treating critically ill patients with intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 23, 2019	Sep 30, 2029	U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity
Pat. No. 9012508 Administration of intravenous ibuprofen Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 23, 2019	Sep 14, 2030	U-981: Management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, reduction in fever through anti-inflammatory, analgesic, and antipyretic activity
Pat. No. 9072661 Injectable ibuprofen formulation Claim Types: Formulation; Drug in a container; Method of use Pat. Sub. Date(s): 003: Sep 4, 2019	Mar 16, 2032	U-2264: Methods of treating pain, inflammation, fever, patent ductus arteriosis with aqueous composition
Pat. No. 9072710 Injectable ibuprofen formulation Claim Types: Formulation; Drug in a container; Process; Method of use Pat. Sub. Date(s): 003: Sep 10, 2019	Mar 16, 2032	U-2266: Methods of making aqueous composition and treating pain, inflammation, fever, patent ductus arteriosis with aqueous composition
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Nov 19, 2024	M-128: Clinical trial study results

Analgesics:Nonsteroidal Anti-inflammatory Drugs
CAMBIA (FOR SOLUTION) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ASSERTIO      NDA No.: 022165  Prod. No.: 001 RX (50MG)

Patents	Expiration	Patented Use
Pat. No. 7759394 DS* DP* Diclofenac formulations and methods of use Claim Types: Method of administration Pat. Sub. Date(s): 001: None	Jun 16, 2026	U-436: Acute treatment of migraine attacks with or without aura in adults
Pat. No. 8097651 DS* DP* Diclofenac formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: None	Jun 16, 2026	U-436: Acute treatment of migraine attacks with or without aura in adults
Pat. No. 8927604 Diclofenac formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2015	Jun 16, 2026	U-436: Acute treatment of migraine attacks with or without aura in adults
Pat. No. 9827197 DP* Diclofenac formulations and methods of use Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 5, 2017	Jun 16, 2026

Analgesics:Nonsteroidal Anti-inflammatory Drugs
COMBOGESIC (TABLET) (ORAL) ACETAMINOPHEN; IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: AFT PHARMS LTD      NDA No.: 209471  Prod. No.: 001 RX (325MG;97.5MG)

Patents	Expiration	Patented Use
Pat. No. 10532036 Combination composition Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 29, 2023	Sep 22, 2025	U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration
Pat. No. 11197830 DP* Pharmaceutical composition containing acetaminophen and ibuprofen Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2023	Feb 27, 2039	U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration
Pat. No. 11534407 DP* Pharmaceutical compostion containing acetominophen and ibuprofen Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics; Method of use Pat. Sub. Date(s): 001: Mar 29, 2023	Feb 27, 2039	U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration

Analgesics:Nonsteroidal Anti-inflammatory Drugs
CONSENSI (TABLET) (ORAL) AMLODIPINE BESYLATE; CELECOXIB
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: PURPLE BIOTECH      NDA No.: 210045  Prod. No.: 001 DISC (EQ 2.5MG BASE;200MG); 002 DISC (EQ 5MG BASE;200MG); 003 DISC (EQ 10MG BASE;200MG)

Patents	Expiration	Patented Use
Pat. No. 9408837 Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 11, 2020	Feb 28, 2030	U-2410: Treatment of adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
Pat. No. 9662315 DP* Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 16, 2018	May 22, 2029	U-2410: Treatment of adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
Pat. No. 10350171 DP* Celecoxib and amlodipine formulation and method of making the same Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Sep 6, 2019	Jun 14, 2038
Pat. No. 10925835 Celecoxib and amlodipine formulation and method of making the same Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 22, 2021	Jun 14, 2038	U-2410: Treatment of adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
Pat. No. 10945960 DP* Celecoxib and amlodipine formulation and method of making the same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 22, 2021	Jun 14, 2038

Analgesics:Nonsteroidal Anti-inflammatory Drugs
DUEXIS (TABLET) (ORAL) FAMOTIDINE; IBUPROFEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON      NDA No.: 022519  Prod. No.: 001 RX (26.6MG;800MG)

Patents	Expiration	Patented Use
Pat. No. 8067451 DP* Methods and medicaments for administration of ibuprofen Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 30, 2011	Jul 18, 2026	U-1196: Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications
Pat. No. 8309127 DP* Stable compositions of famotidine and ibuprofen Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 13, 2012	Jul 18, 2026
Pat. No. 8318202 DP* Stable compositions of famotidine and ibuprofen Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 27, 2012	Jul 18, 2026
Pat. No. 8449910 DP* Stable compositions of famotidine and ibuprofen Claim Types: Formulation Pat. Sub. Date(s): 001: May 28, 2013	Jul 18, 2026
Pat. No. 8501228 Stable compositions of famotidine and ibuprofen Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 6, 2013	Jul 18, 2026	U-1196: Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications

Analgesics:Nonsteroidal Anti-inflammatory Drugs
DYLOJECT (SOLUTION) (INTRAVENOUS) DICLOFENAC SODIUM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: JAVELIN PHARMS INC      NDA No.: 022396  Prod. No.: 001 DISC (37.5MG/ML (37.5MG/ML)**)

Patents	Expiration	Patented Use
Pat. No. 8946292 Formulations of low dose diclofenac and beta-cyclodextrin Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 27, 2015	Mar 22, 2027	U-1659: Management of pain

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ELYXYB (SOLUTION) (ORAL) CELECOXIB
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: SCILEX HLDG      NDA No.: 212157  Prod. No.: 001 DISC (25MG/ML)

Patents	Expiration	Patented Use
Pat. No. 9572819 DP* Oral composition of celecoxib for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 11, 2020	May 27, 2036	U-2718: Acute treatment of migraine with or without aura in adults
Pat. No. 9795620 DP* Oral composition of celecoxib for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: May 11, 2020	May 27, 2036	U-2718: Acute treatment of migraine with or without aura in adults
Pat. No. 9949990 DP* Oral composition of celecoxib for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 11, 2020	May 27, 2036	U-2718: Acute treatment of migraine with or without aura in adults
Pat. No. 10376527 DP* Oral composition of celecoxib for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: May 11, 2020	May 27, 2036	U-2718: Acute treatment of migraine with or without aura in adults
Pat. No. 10722456 DP* Oral composition of celecoxib for treatment of pain Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 14, 2020	May 27, 2036	U-2718: Acute treatment of migraine with or without aura in adults
Pat. No. 10799517 DP* Oral composition of celecoxib for treatment of pain Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 28, 2020	May 27, 2036	U-2718: Acute treatment of migraine with or without aura in adults
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	May 5, 2023

Analgesics:Nonsteroidal Anti-inflammatory Drugs
FENOPROFEN CALCIUM (CAPSULE) (ORAL) FENOPROFEN CALCIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: RISING      NDA No.: 214475  Prod. No.: 001 RX (EQ 400MG BASE)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: CGT - Competitive generic therapy	Feb 11, 2023

Analgesics:Nonsteroidal Anti-inflammatory Drugs
LICART (SYSTEM) (TOPICAL) DICLOFENAC EPOLAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: IBSA INST BIO      NDA No.: 206976  Prod. No.: 001 RX (1.3%)

Patents	Expiration	Patented Use
Pat. No. 11344520 Effects of heparin on topical use of plasters containing a non-steroidal anti-inflammatory drug Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 29, 2022	Feb 20, 2035	U-3393: Method of treating acute pain due to minor strains, sprains, and contusions using a diclofenac patch containing heparin for once daily administration where heparin is not released
Pat. No. 11351133 Effects of heparin on topical use of plasters containing a non-steroidal anti-inflammatory drug Claim Types: Method of administration Pat. Sub. Date(s): 001: Jun 29, 2022	Feb 20, 2035	U-3393: Method of treating acute pain due to minor strains, sprains, and contusions using a diclofenac patch containing heparin for once daily administration where heparin is not released

Analgesics:Nonsteroidal Anti-inflammatory Drugs
NAPROXEN SODIUM (CAPSULE) (ORAL) NAPROXEN SODIUM [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BIONPHARMA INC      NDA No.: 021920  Prod. No.: 001 OTC (EQ 200MG BASE)

Patents	Expiration	Patented Use
Pat. No. 9693978 DP* Solvent system for enhancing the solubility of pharmaceutical agents Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Nov 13, 2017	Mar 3, 2026
Pat. No. 9693979 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Nov 13, 2017	Mar 3, 2026
Pat. No. 10022344 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jul 23, 2018	Mar 3, 2026	U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever
Pat. No. 10028925 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 24, 2018	Mar 3, 2026	U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever
Pat. No. 11090280 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 24, 2021	Mar 3, 2026	U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever

Analgesics:Nonsteroidal Anti-inflammatory Drugs
NEOPROFEN (INJECTABLE) (INTRAVENOUS) IBUPROFEN LYSINE [GENERIC AP]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: RECORDATI RARE      NDA No.: 021903  Prod. No.: 001 RX (EQ 20MG BASE/2ML (EQ 10MG BASE/ML))

Patents	Expiration	Patented Use
Pat. No. 8415337 DS* DP* Ibuprofen compositions and methods of making same Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Apr 11, 2013	Mar 2, 2032

Analgesics:Nonsteroidal Anti-inflammatory Drugs
OMIDRIA (SOLUTION) (IRRIGATION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == Ophthalmic Agents:Ophthalmic Combinations
NDA Applicant: RAYNER SURGICAL      NDA No.: 205388  Prod. No.: 001 RX (EQ 0.3% BASE;EQ 1% BASE)

Patents	Expiration	Patented Use
Pat. No. 8173707 Ophthalmologic irrigation solutions and method Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 13, 2014	Jan 30, 2024 *PED	U-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain
Pat. No. 8586633 DP* Ophthalmologic irrigation solutions and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 13, 2014	Jan 30, 2024 *PED
Pat. No. 9066856 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 13, 2015	Apr 23, 2034 *PED
Pat. No. 9278101 Ophthalmologic irrigation solutions and method Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 9, 2016	Jan 30, 2024 *PED	U-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain
Pat. No. 9399040 DP* Ophthalmologic irrigation solutions and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 28, 2016	Jan 30, 2024 *PED
Pat. No. 9486406 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 9, 2016	Apr 23, 2034 *PED
Pat. No. 9855246 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 5, 2018	Oct 23, 2033

Analgesics:Nonsteroidal Anti-inflammatory Drugs
PENNSAID (SOLUTION) (TOPICAL) DICLOFENAC SODIUM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: NUVO PHARMS INC      NDA No.: 020947  Prod. No.: 001 DISC (1.5%**)

Patents	Expiration	Patented Use
Pat. No. 8217078 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 11, 2012	Jul 10, 2029	U-1248: Use of topical diclofenac on the knee and a second topical medication on the same knee
Pat. No. 8546450 Treatment of pain with topical diclofenac compounds Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Oct 4, 2013	Aug 9, 2030	U-1435: Combination use of topical diclofenac on the knee and administration of an oral NSAID. U-1436: Use of topical diclofenac on the knee and a second topical agent selected from sunscreen and insect repellant
Pat. No. 8618164 Treatment of pain with topical diclofenac compounds Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 10, 2014	Jul 10, 2029	U-1477: Use of topical diclofenac on the knee and a second topical prescription medication on the same knee
Pat. No. 8741956 Treatment of pain with topical diclofenac Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 5, 2014	Jul 10, 2029	U-1435: Combination use of topical diclofenac on the knee and administration of an oral NSAID.

Analgesics:Nonsteroidal Anti-inflammatory Drugs
PENNSAID (SOLUTION) (TOPICAL) DICLOFENAC SODIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: HORIZON      NDA No.: 204623  Prod. No.: 001 RX (2%)

Patents	Expiration	Patented Use
Pat. No. 8217078 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 25, 2014	Jul 10, 2029	U-1477: Use of topical diclofenac on the knee and a second topical prescription medication on the same knee
Pat. No. 8252838 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2014	Apr 21, 2028	U-1489: Use of topical diclofenac on a joint for treating osteoarthritis
Pat. No. 8546450 Treatment of pain with topical diclofenac compounds Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Feb 25, 2014	Aug 9, 2030	U-1435: Combination use of topical diclofenac on the knee and administration of an oral NSAID. U-1436: Use of topical diclofenac on the knee and a second topical agent selected from sunscreen and insect repellant
Pat. No. 8563613 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2014	Oct 17, 2027	U-1488: Use of topical diclofenac for treating pain
Pat. No. 8618164 Treatment of pain with topical diclofenac compounds Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 25, 2014	Jul 10, 2029	U-1477: Use of topical diclofenac on the knee and a second topical prescription medication on the same knee
Pat. No. 8741956 Treatment of pain with topical diclofenac Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jun 5, 2014	Jul 10, 2029	U-1435: Combination use of topical diclofenac on the knee and administration of an oral NSAID.
Pat. No. 8871809 Diclofenac topical formulation Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 18, 2014	Oct 17, 2027	U-1614: Use of topical diclofenac sodium for treating pain
Pat. No. 9066913 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 30, 2015	Oct 17, 2027	U-1488: Use of topical diclofenac for treating pain
Pat. No. 9101591 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 11, 2015	Oct 17, 2027	U-1488: Use of topical diclofenac for treating pain
Pat. No. 9132110 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 16, 2015	Oct 17, 2027	U-1488: Use of topical diclofenac for treating pain
Pat. No. 9168304 DP* Diclofenac topical formulation Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 27, 2015	Oct 17, 2027
Pat. No. 9168305 Diclofenac topical formulation Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 27, 2015	Oct 17, 2027	U-1488: Use of topical diclofenac for treating pain
Pat. No. 9220784 Diclofenac topical formulation Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 28, 2016	Oct 17, 2027	U-1488: Use of topical diclofenac for treating pain
Pat. No. 9339551 Diclofenac topical formulation Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 16, 2016	Oct 17, 2027	U-1488: Use of topical diclofenac for treating pain
Pat. No. 9339552 DP* Diclofenac topical formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 16, 2016	Oct 17, 2027	U-1488: Use of topical diclofenac for treating pain
Pat. No. 9370501 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 19, 2016	Jul 10, 2029	U-1614: Use of topical diclofenac sodium for treating pain
Pat. No. 9375412 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 26, 2016	Jul 10, 2029	U-1614: Use of topical diclofenac sodium for treating pain
Pat. No. 9415029 Treatment of pain with topical diclofenac Claim Types: Method of administration Pat. Sub. Date(s): 001: Sep 13, 2016	Jul 10, 2029	U-1614: Use of topical diclofenac sodium for treating pain
Pat. No. 9539335 Diclofenac topical formulation Claim Types: Method of use; Process Pat. Sub. Date(s): 001: Feb 6, 2016	Oct 17, 2027	U-1614: Use of topical diclofenac sodium for treating pain

Analgesics:Nonsteroidal Anti-inflammatory Drugs
QMIIZ ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: TERSERA      NDA No.: 211210  Prod. No.: 001 DISC (7.5MG); 002 DISC (15MG)

Patents	Expiration	Patented Use
Pat. No. 8545879 DP* Fast disintegrating compositions of meloxicam Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 24, 2018	Aug 31, 2030

Analgesics:Nonsteroidal Anti-inflammatory Drugs
SEGLENTIS (TABLET) (ORAL) CELECOXIB; TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: KOWA PHARMS      NDA No.: 213426  Prod. No.: 001 RX (56MG;44MG)

Patents	Expiration	Patented Use
Pat. No. 8598152 DS* DP* Co-crystals of tramadol and coxibs Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 12, 2021	Apr 19, 2030
Pat. No. 8846744 DP* Pharmaceutical compositions of co-crystals of tramadol and coxibs Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Nov 12, 2021	Jun 3, 2031
Pat. No. 9012440 DS* DP* Co-crystals of tramadol and coxibs Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 12, 2021	Apr 19, 2030
Pat. No. 10238668 DS* DP* Co-crystals of tramadol and coxibis Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): 001: Nov 12, 2021	Apr 19, 2030	U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib
Pat. No. 10245276 DS* DP* Co-crystals of tramadol and coxibs Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Nov 12, 2021	Apr 19, 2030
Pat. No. 10548909 Co-crystals of tramadol and coxibs Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 12, 2021	Apr 19, 2030	U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib
Pat. No. 11478488 Co-crystals Of Tramadol And Coxibs Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 7, 2022	Apr 19, 2030	U-3244: A method for treatment of pain in adults using tramadol hydrochloride and celecoxib
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Oct 15, 2024

Analgesics:Nonsteroidal Anti-inflammatory Drugs
TIVORBEX (CAPSULE) (ORAL) INDOMETHACIN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GENUS      NDA No.: 204768  Prod. No.: 001 DISC (20MG); 002 DISC (40MG)

Patents	Expiration	Patented Use
Pat. No. 8734847 DP* Formulation of indomethacin Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 27, 2014	Apr 23, 2030
Pat. No. 8992982 DP* Formulation of indomethacin Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 3, 2015	Apr 23, 2030
Pat. No. 9089471 Formulation of indomethacin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 27, 2015	Apr 23, 2030	U-55: Treatment of pain

Analgesics:Nonsteroidal Anti-inflammatory Drugs
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Antimigraine Agents:Serotonin (5-HT) Receptor Agonists
NDA Applicant: CURRAX      NDA No.: 021926  Prod. No.: 001 RX (500MG;EQ 85MG BASE)

Patents	Expiration	Patented Use
Pat. No. 7332183 DP* Multilayer dosage forms containing NSAIDs and triptans Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: None	Apr 2, 2026 *PED	U-867: Treatment of migraine

Analgesics:Nonsteroidal Anti-inflammatory Drugs
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Antimigraine Agents:Serotonin (5-HT) Receptor Agonists
NDA Applicant: CURRAX      NDA No.: 021926  Prod. No.: 002 DISC (60MG;EQ 10MG BASE)

Patents	Expiration	Patented Use
Pat. No. 7332183 DP* Multilayer dosage forms containing NSAIDs and triptans Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 002: Jul 27, 2015	Apr 2, 2026 *PED	U-1719: Acute treatment of migraine

Analgesics:Nonsteroidal Anti-inflammatory Drugs
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON      NDA No.: 022511  Prod. No.: 001 RX (EQ 20MG BASE;500MG)

Patents	Expiration	Patented Use
Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 2, 2015	Oct 17, 2031	U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin
Pat. No. 9220698 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 28, 2016	Mar 10, 2031	U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 17, 2016	Sep 3, 2029	U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment

Analgesics:Nonsteroidal Anti-inflammatory Drugs
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON      NDA No.: 022511  Prod. No.: 002 RX (EQ 20MG BASE;375MG)

Patents	Expiration	Patented Use
Pat. No. 8945621 Method for treating a patient at risk for developing an NSAID-associated ulcer Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 002: Mar 2, 2015	Oct 17, 2031	U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin
Pat. No. 9393208 Method for delivering a pharmaceutical composition to patient in need thereof Claim Types: Method of administration Pat. Sub. Date(s): 002: Aug 17, 2016	Sep 3, 2029	U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment

Analgesics:Nonsteroidal Anti-inflammatory Drugs
VIVLODEX (CAPSULE) (ORAL) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: ICEUTICA OPERATIONS      NDA No.: 207233  Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**)

Patents	Expiration	Patented Use
Pat. No. 9526734 DP* Formulation of meloxicam Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 30, 2016	Mar 31, 2033
Pat. No. 9649318 DP* Formulation of meloxicam Claim Types: Composition Pat. Sub. Date(s): All strengths: May 16, 2017	Mar 31, 2035
Pat. No. 9808468 Formulation of meloxicam Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 22, 2017	Mar 31, 2035	U-2160: Management of osteoarthritis pain by administering 5 mg of meloxicam U-2165: Management of osteoarthritis pain by administering 10 mg of meloxicam

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ZIPSOR (CAPSULE) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ASSERTIO      NDA No.: 022202  Prod. No.: 001 RX (25MG)

Patents	Expiration	Patented Use
Pat. No. 7662858 Method of treating post-surgical acute pain Claim Types: Method of administration Pat. Sub. Date(s): 001: None	Feb 24, 2029	U-1035: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 7884095 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 22, 2011	Feb 24, 2029	U-1111: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 7939518 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2011	Feb 24, 2029	U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 8110606 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 13, 2012	Feb 24, 2029	U-980: Nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain
Pat. No. 8623920 Method of treating post-surgical acute pain Claim Types: Method of administration Pat. Sub. Date(s): 001: Feb 5, 2014	Feb 24, 2029	U-1482: Diclofenac potassium for relief of mild to moderate acute pain
Pat. No. 9561200 Method of treating post-surgical acute pain Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 14, 2017	Feb 24, 2029	U-1482: Diclofenac potassium for relief of mild to moderate acute pain
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	May 25, 2024

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ZORVOLEX (CAPSULE) (ORAL) DICLOFENAC
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ZYLA      NDA No.: 204592  Prod. No.: 001 DISC (18MG**); 002 DISC (35MG)

Patents	Expiration	Patented Use
Pat. No. 8679544 DP* Formulation of diclofenac Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 25, 2014	Apr 23, 2030
Pat. No. 8999387 Formulation of diclofenac Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 7, 2015	Apr 23, 2030	U-55: Treatment of pain
Pat. No. 9017721 DP* Formulation of diclofenac Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 29, 2015	Apr 23, 2030
Pat. No. 9173854 DP* Formulation of diclofenac Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 5, 2015	Apr 23, 2030
Pat. No. 9180095 Formulation of diclofenac Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 12, 2015	Apr 23, 2030	U-55: Treatment of pain
Pat. No. 9180096 DP* Formulation of diclofenac Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 12, 2015	Apr 23, 2030
Pat. No. 9186328 Formulation of diclofenac Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 19, 2015	Apr 23, 2030	U-55: Treatment of pain

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ZYNRELEF KIT (SOLUTION, EXTENDED RELEASE) (PERIARTICULAR) BUPIVACAINE; MELOXICAM
Drug Classes: Anesthetics:Local Anesthetics == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HERON THERAPS INC      NDA No.: 211988  Prod. No.: 002 RX (200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)); 004 RX (400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)) NDA No.: 211988  Prod. No.: 001 DISC (60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)); 003 DISC (300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML))

Patents	Expiration	Patented Use
Pat. No. 9592227 DP* Compositions of a polyorthoester and an aprotic solvent Claim Types: Formulation; Method of administration; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021	Mar 13, 2034	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 9694079 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021	Apr 20, 2035	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 9744163 DP* Compositions of a polyorthoester and an aprotic solvent Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 26, 2021	Mar 13, 2034
Pat. No. 9801945 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021	Apr 20, 2035	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 9913909 Compositions of a polyorthoester and an aprotic solvent Claim Types: Method of administration; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021	Mar 13, 2034	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10098957 Long-acting polymeric delivery systems Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 26, 2021	Apr 20, 2035	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10213510 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021	Apr 20, 2035	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10398686 DP* Compositions of a polyorthoester and an aprotic solvent Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 26, 2021	Mar 13, 2034
Pat. No. 10632199 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: May 26, 2021	Apr 20, 2035	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10898575 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): All strengths: May 26, 2021	Apr 20, 2035	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 10980886 DP* Compositions of a polyorthoester and an organic acid excipient Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 26, 2021	Apr 20, 2035
Pat. No. 11083730 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 25, 2021	Apr 20, 2035	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 11083797 DP* Long-acting polymeric delivery systems Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 25, 2021	Apr 20, 2035	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 11253504 Compositions of a polyorthoester and an aprotic solvent Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 2, 2022	Mar 13, 2034	U-3118: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarticular instillation
Pat. No. 11413350 Long-acting polymeric delivery systems Claim Types: Method of use; Method of improving a treatment Pat. Sub. Date(s): All strengths: Sep 15, 2022	Apr 20, 2035	U-3417: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures via instillation
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	May 12, 2024

Analgesics:Opioid Analgesics, Long-acting
ARYMO ER (TABLET, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ZYLA      NDA No.: 208603  Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG)

Patents	Expiration	Patented Use
Pat. No. 9044402 DP* Abuse-deterrent pharmaceutical compositions for controlled release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 8, 2017	Jul 1, 2033	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. 9549899 DP* Abuse deterrent pharmaceutical compositions for controlled release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 21, 2017	Jul 1, 2033	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.

Analgesics:Opioid Analgesics, Long-acting
BELBUCA (FILM) (BUCCAL) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence
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. 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.

Analgesics:Opioid Analgesics, Long-acting
BUNAVAIL (FILM) (BUCCAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents
NDA Applicant: BDSI      NDA No.: 205637  Prod. No.: 001 DISC (EQ 2.1MG BASE;EQ 0.3MG BASE); 002 DISC (EQ 4.2MG BASE;EQ 0.7MG BASE); 003 DISC (EQ 6.3MG BASE;EQ 1MG BASE)

Patents	Expiration	Patented Use
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. 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
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

Analgesics:Opioid Analgesics, Long-acting
DILAUDID-HP (INJECTABLE) (INJECTION) HYDROMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: FRESENIUS KABI USA      NDA No.: 019034  Prod. No.: 003 RX (1MG/ML); 004 RX (2MG/ML) NDA No.: 019034  Prod. No.: 001 DISC (10MG/ML); 002 DISC (250MG/VIAL); 005 DISC (4MG/ML)

Patents	Expiration	Patented Use
Pat. No. 9248229 DP* Packaging system for oxygen-sensitive drugs Claim Types: Drug in a container Pat. Sub. Date(s): All strengths: Feb 5, 2018	Mar 12, 2034
Pat. No. 9731082 DP* Drug container Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Feb 5, 2018	Apr 23, 2032

Analgesics:Opioid Analgesics, Long-acting
EMBEDA (CAPSULE, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents
NDA Applicant: ALPHARMA PHARMS      NDA No.: 022321  Prod. No.: 001 DISC (20MG;0.8MG**); 002 DISC (30MG;1.2MG**); 003 DISC (50MG;2MG**); 004 DISC (60MG;2.4MG**); 005 DISC (80MG;3.2MG**); 006 DISC (100MG;4MG**)

Patents	Expiration	Patented Use
Pat. No. 7682633 Pharmaceutical composition Claim Types: Method of use Pat. Sub. Date(s): All strengths: None	Jun 19, 2027	U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed.
Pat. No. 7682634 DP* Pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: None	Jun 19, 2027
Pat. No. 7815934 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 19, 2010; 002: None; 003: None; 004: None; 005: None; 006: None	Dec 12, 2027
Pat. No. 8158156 Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Method of use Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: None; 004: None; 005: None; 006: None	Jun 19, 2027	U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed.
Pat. No. 8623418 Pharmaceutical composition Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Jan 22, 2015	Nov 7, 2029	U-1640: Treatment of moderate to severe chronic pain by administering an intact composition as claimed
Pat. No. 8685443 Sequestering subunit and related compositions and methods Claim Types: Method of use Pat. Sub. Date(s): All strengths: None	Jul 3, 2025	U-1508: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering a plurality of composite subunits as claimed
Pat. No. 8685444 DP* Sequestering subunit and related compositions and methods Claim Types: Formulation Pat. Sub. Date(s): All strengths: None	Jul 3, 2025
Pat. No. 8846104 DP* Pharmaceutical compositions for the deterrence and/or prevention of abuse Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 28, 2014	Jun 19, 2027
Pat. No. 8877247 DP* Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014	Jun 19, 2027

Analgesics:Opioid Analgesics, Long-acting
FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: CEPHALON      NDA No.: 021947  Prod. No.: 001 RX (EQ 0.1MG BASE)

Patents	Expiration	Patented Use
Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2011	Jun 15, 2028
Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2011	Jun 15, 2028
Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 13, 2012	Dec 30, 2024

Analgesics:Opioid Analgesics, Long-acting
FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: CEPHALON      NDA No.: 021947  Prod. No.: 002 RX (EQ 0.2MG BASE); 003 RX (EQ 0.4MG BASE); 004 RX (EQ 0.6MG BASE); 005 RX (EQ 0.8MG BASE)

Patents	Expiration	Patented Use
Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011	Jun 15, 2028
Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates Claim Types: Formulation Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011	Jun 15, 2028
Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering Claim Types: Formulation Pat. Sub. Date(s): All strengths: None	Dec 30, 2024
Pat. No. 8119158 DP* Effervescent oral fentanyl dosage form and methods of administering fentanyl Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 002: Feb 23, 2012; 003: None; 004: None; 005: None	Dec 30, 2024

Analgesics:Opioid Analgesics, Long-acting
HYSINGLA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough
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. 8309060 DP* Abuse-proofed dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 21, 2014	Nov 20, 2023	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. 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. 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. 9675610 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 12, 2017	Jun 16, 2023
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. 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. 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
Pat. No. 10130591 DP* Abuse-proofed dosage form Claim Types: Method of use; Product-by-process Pat. Sub. Date(s): All strengths: Nov 27, 2018	Nov 20, 2023	U-1819: 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. 10369109 DP* Abuse-proofed dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 9, 2019	Jun 16, 2023
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.