Orange Book Companion®
Drug Classes starting with "ADEN" through "ANES"

Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.


adenosine triphosphate-citrate lyase (ACL) inhibitor
NEXLETOL (TABLET) (ORAL) BEMPEDOIC ACID
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == adenosine triphosphate-citrate lyase (ACL) inhibitor
NDA Applicant: ESPERION THERAPS INC      NDA No.:
211616  Prod. No.: 001 RX (180MG)
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-2747: Use of NEXLETOL 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-2747: Use of NEXLETOL 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-2748: Use of NEXLETOL 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-2747: Use of NEXLETOL 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. 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-2747: Use of NEXLETOL 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  

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.

Analgesics:Opioid Analgesics, Long-acting
IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: THE MEDICINES CO      NDA No.:
021338  Prod. No.: 001 DISC (EQ 40MCG BASE/ACTIVATION)
Patents Expiration Patented Use
Pat. No. 6975902 DP* Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 1, 2024  
Pat. No. 8301238 DP* Two-part electrotransport device
Claim Types: Device
Pat. Sub. Date(s): 001: None
Sep 30, 2031  
Pat. No. 8428708 Self-test for analgesic product
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: None
May 21, 2032 U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8428709 DP* Current control for electrotransport drug delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: May 28, 2015
Jun 11, 2032 U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8781571 DP* Switch validation circuit and method
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): 001: May 28, 2015
Mar 31, 2032 U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9095706 DP* Self-test for analgesic product
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 3, 2033  
Pat. No. 9364656 Method of storing an electrotransport drug delivery device
Claim Types: Process
Pat. Sub. Date(s): 001: Jun 21, 2016
Sep 30, 2031 U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9731121 DP* Switch validation circuit and method
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 12, 2017
Oct 17, 2031  

Analgesics:Opioid Analgesics, Long-acting
LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
022569  Prod. No.: 001 DISC (EQ 0.1MG BASE); 002 DISC (EQ 0.4MG BASE)
Patents Expiration Patented Use
Pat. No. 8216604 Method of managing or treating pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 19, 2012; 002: None
Oct 3, 2024 U-767: Management of breakthrough pain in patients with cancer
Pat. No. 8889176 Method of managing or treating pain
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Dec 12, 2014
Jan 16, 2024 U-767: Management of breakthrough pain in patients with cancer
Pat. No. 9078814 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Drug in a container
Pat. Sub. Date(s): All strengths: Aug 11, 2015
Jan 8, 2024  
Pat. No. 9731869 DP* Container
Claim Types: Packaging or device material
Pat. Sub. Date(s): All strengths: Sep 1, 2017
Jan 26, 2032  
Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 13, 2017
Jan 8, 2024  

Analgesics:Opioid Analgesics, Long-acting
LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
022569  Prod. No.: 003 DISC (EQ 0.3MG BASE)
Patents Expiration Patented Use
Pat. No. 9731869 DP* Container
Claim Types: Packaging or device material
Pat. Sub. Date(s): 003: Sep 1, 2017
Jan 26, 2032  
Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 13, 2017
Jan 8, 2024  

Analgesics:Opioid Analgesics, Long-acting
MORPHABOND ER (TABLET, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: DAIICHI SANKYO INC      NDA No.:
206544  Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG); 004 DISC (100MG)
Patents Expiration Patented Use
Pat. No. 7955619 DP* Abuse resistant drugs, method of use and method of making
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): All strengths: Mar 24, 2016
Aug 12, 2028  
Pat. No. 10314788 DP* Pharmaceutical compositions configured to deter dosage form splitting
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 10, 2019
Aug 12, 2028  

Analgesics:Opioid Analgesics, Long-acting
MORPHINE SULFATE (SOLUTION) (ORAL) MORPHINE SULFATE [GENERIC AA]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: HIKMA      NDA No.:
022195  Prod. No.: 001 RX (10MG/5ML); 002 RX (20MG/5ML)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NPP - New patient population Jun 2, 2024  

Analgesics:Opioid Analgesics, Long-acting
MORPHINE SULFATE (TABLET) (ORAL) MORPHINE SULFATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: HIKMA      NDA No.:
022207  Prod. No.: 001 RX (15MG); 002 RX (30MG)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NPP - New patient population Jun 2, 2024  

Analgesics:Opioid Analgesics, Long-acting
MORPHINE SULFATE (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS) MORPHINE SULFATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: FRESENIUS KABI USA      NDA No.:
204223  Prod. No.: 001 RX (2MG/ML (2MG/ML)); 002 RX (4MG/ML (4MG/ML)); 003 RX (5MG/ML (5MG/ML)); 004 RX (8MG/ML (8MG/ML)); 005 RX (10MG/ML (10MG/ML))
Patents Expiration Patented Use
Pat. No. 9072781 DP* Morphine formulations
Claim Types: Formulation; Kit
Pat. Sub. Date(s): All strengths: Jul 13, 2015
Mar 12, 2034  
Pat. No. 9192608 Morphine formulations
Claim Types: Method of use; Method of improving a treatment
Pat. Sub. Date(s): All strengths: Dec 4, 2015
Mar 12, 2034 U-43: Management of chronic pain in patients requiring opioid analgesia
U-55: Treatment of pain
Pat. No. 9248229 DP* Packaging system for oxygen-sensitive drugs
Claim Types: Drug in a container
Pat. Sub. Date(s): All strengths: Feb 17, 2016
Mar 12, 2034  

Analgesics:Opioid Analgesics, Long-acting
NUCYNTA (TABLET) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: COLLEGIUM PHARM INC      NDA No.:
022304  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE); 003 RX (EQ 100MG BASE)
Patents Expiration Patented Use
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None
Jun 27, 2025 U-931: Relief of moderate to severe acute pain

Analgesics:Opioid Analgesics, Long-acting
NUCYNTA (SOLUTION) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: COLLEGIUM PHARM INC      NDA No.:
203794  Prod. No.: 001 DISC (EQ 20MG BASE/ML)
Patents Expiration Patented Use
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Jun 27, 2025 U-1289: Management of moderate to severe acute pain

Analgesics:Opioid Analgesics, Long-acting
NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: COLLEGIUM PHARM INC      NDA No.:
200533  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 200MG BASE); 005 RX (EQ 250MG BASE)
Patents Expiration Patented Use
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None; 004: None; 005: None
Jun 27, 2025 U-1178: Relief of moderate to severe chronic pain
U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 8075872 DP* Abuse-proofed dosage form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 9, 2012; 002: None; 003: None; 004: None; 005: None
Nov 20, 2023  
Pat. No. 8114383 DP* DLR* Abuse-proofed dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 14, 2012; 002: None; 003: None; 004: None; 005: None
Oct 10, 2024  
Pat. No. 8309060 DP* Abuse-proofed dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 5, 2012; 002: None; 003: None; 004: None; 005: None
Nov 20, 2023 U-1178: Relief of moderate to severe chronic pain
U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 8420056 DP* Abuse-proofed dosage form
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: May 2, 2013; 002: None; 003: None; 004: None; 005: None
Nov 20, 2023  
Pat. No. 8536130 Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Sep 22, 2028 U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 11344512 Titration of tapentadol
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 29, 2022
Apr 21, 2028 U-3391: A method of titrating an opioid to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate
U-3392: A method of titrating an opioid to manage neuropathic pain associated with diabetic peripheral neuropathy 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
OBREDON (SOLUTION) (ORAL) GUAIFENESIN; HYDROCODONE BITARTRATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cold-Cough == Analgesics:Opioid Analgesics, Long-acting
NDA Applicant: SOVEREIGN PHARMS      NDA No.:
205474  Prod. No.: 001 DISC (200MG/5ML;2.5MG/5ML)
Patents Expiration Patented Use
Pat. No. 9549907 DS* DP* Immediate release oral guaifenesin solution
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 30, 2017
Nov 13, 2035 U-2023: A method of increasing the bioavailability of guaifenesin in a solution containing 54% to 66% by weight of propylene glycol and glycerol, wherein the method increases the cmax by at least 1.5 and/or increases the auc (0-inf) by at least 1.4
Pat. No. 9808431 DS* DP* Immediate release oral guaifenesin solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 16, 2018
Nov 13, 2035 U-2023: A method of increasing the bioavailability of guaifenesin in a solution containing 54% to 66% by weight of propylene glycol and glycerol, wherein the method increases the cmax by at least 1.5 and/or increases the auc (0-inf) by at least 1.4
Pat. No. 10105324 DS* DP* Immediate release oral guaifenesin solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2018
Nov 13, 2035 U-2023: A method of increasing the bioavailability of guaifenesin in a solution containing 54% to 66% by weight of propylene glycol and glycerol, wherein the method increases the cmax by at least 1.5 and/or increases the auc (0-inf) by at least 1.4

Analgesics:Opioid Analgesics, Long-acting
ONSOLIS (FILM) (BUCCAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ADALVO      NDA No.:
022266  Prod. No.: 001 DISC (EQ 0.2MG BASE); 002 DISC (EQ 0.4MG BASE); 003 DISC (EQ 0.6MG BASE); 004 DISC (EQ 0.8MG BASE); 005 DISC (EQ 1.2MG BASE)
Patents Expiration Patented Use
Pat. No. 9597288 DP* Transmucosal delivery devices with enhanced uptake
Claim Types: Method of administration; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 3, 2017
Jul 23, 2027 U-767: Management of breakthrough pain in patients with cancer

Analgesics:Opioid Analgesics, Long-acting
OPANA (TABLET) (ORAL) OXYMORPHONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ENDO PHARMS      NDA No.:
021611  Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: M - Miscellaneous Oct 25, 2022 M-14: Additional clinical trial information added to pediatric use subsection

Analgesics:Opioid Analgesics, Long-acting
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ENDO PHARMS      NDA No.:
021610  Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**); 003 DISC (20MG**); 004 DISC (40MG**); 005 DISC (7.5MG**); 006 DISC (15MG**); 007 DISC (30MG**)
Patents Expiration Patented Use
Pat. No. 7276250 DP* Sustained release formulations of oxymorphone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 4, 2023 U-826: Relief of moderate to severe pain
Pat. No. 8309112 DP* Coatings for implantable medical devices comprising hydrophilic substances and methods for fabricating the same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Feb 4, 2023  
Pat. No. 8329216 DP* Oxymorphone controlled release formulations
Claim Types: Formulation; Method of use; Product-by-process
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Feb 4, 2023  
Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Jun 21, 2027 U-3085: Dose modification for renal impairment
Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Nov 22, 2029  

Analgesics:Opioid Analgesics, Long-acting
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ENDO PHARMS      NDA No.:
201655  Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG); 003 DISC (10MG); 004 DISC (15MG); 005 DISC (20MG); 006 DISC (30MG); 007 DISC (40MG)
Patents Expiration Patented Use
Pat. No. 7851482 DS* Method for making analgesics
Claim Types: Composition; Method of use; Process
Pat. Sub. Date(s): 001: Mar 22, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Jul 10, 2029  
Pat. No. 8075872 DP* Abuse-proofed dosage form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Dec 13, 2011; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Nov 20, 2023  
Pat. No. 8114383 DP* Abuse-proofed dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Aug 8, 2024  
Pat. No. 8192722 DP* Abuse-proof dosage form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jun 5, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Sep 15, 2025  
Pat. No. 8309060 DP* Abuse-proofed dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Nov 20, 2023  
Pat. No. 8309122 DP* Oxymorphone controlled release formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Feb 4, 2023  
Pat. No. 8329216 DP* Oxymorphone controlled release formulations
Claim Types: Formulation; Method of use; Product-by-process
Pat. Sub. Date(s): 001: Dec 11, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Feb 4, 2023  
Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 7, 2014
Jun 21, 2027 U-1598: Method of administration of controlled release oxymorphone
Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 7, 2014
Nov 22, 2029  

Analgesics:Opioid Analgesics, Long-acting
OXAYDO (TABLET) (ORAL) OXYCODONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ZYLA      NDA No.:
202080  Prod. No.: 001 RX (5MG); 002 RX (7.5MG)
Patents Expiration Patented Use
Pat. No. 7201920 DP* Methods and compositions for deterring abuse of opioid containing dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 14, 2011
Mar 16, 2025  
Pat. No. 7510726 DP* Methods and compositions for deterring abuse of opioid containing dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 14, 2011
Nov 26, 2023  
Pat. No. 7981439 DP* Methods and compositions for deterring abuse of drugs susceptible to abuse and dosage forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 9, 2011; 002: None
Nov 26, 2023  
Pat. No. 8409616 DP* Extended release opioid abuse deterrent compositions and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Nov 26, 2023  
Pat. No. 8637540 DP* Compositions for deterring abuse of opioid containing dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 20, 2014
Nov 26, 2023  
Pat. No. 9492443 DP* Abuse deterrent compositions and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 18, 2016
May 26, 2024  

Analgesics:Opioid Analgesics, Long-acting
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA LP      NDA No.:
022272  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG)
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 14, 2012
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. 8808741 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 19, 2014
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. 8894987 DP* Tamper resistant dosage forms
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Mar 29, 2030  
Pat. No. 8894988 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Aug 24, 2027  
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025  
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. 9492391 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 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. 9492392 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027  
Pat. No. 9492393 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 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. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025  
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. 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. 9775808 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 4, 2017
Aug 24, 2027  
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. 10407434 DS* Process for preparing oxycodone compositions
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Mar 30, 2025  
Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 10, 2020
Nov 20, 2023  
Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Product-by-process; Composition
Pat. Sub. Date(s): All strengths: Jun 30, 2020
Mar 30, 2025  
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.

Analgesics:Opioid Analgesics, Long-acting
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA LP      NDA No.:
022272  Prod. No.: 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
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 14, 2012
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. 8808741 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 19, 2014
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. 8894988 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Aug 24, 2027  
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025  
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. 9492391 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 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. 9492392 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027  
Pat. No. 9492393 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 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. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025  
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. 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. 9775808 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 4, 2017
Aug 24, 2027  
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. 10407434 DS* Process for preparing oxycodone compositions
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Mar 30, 2025  
Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 10, 2020
Nov 20, 2023  
Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Product-by-process; Composition
Pat. Sub. Date(s): All strengths: Jun 30, 2020
Mar 30, 2025  
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.

Analgesics:Opioid Analgesics, Long-acting
PROBUPHINE (IMPLANT) (IMPLANTATION) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence
NDA Applicant: TITAN PHARMS      NDA No.:
204442  Prod. No.: 001 DISC (EQ 80MG BASE/IMPLANT)
Patents Expiration Patented Use
Pat. No. 7736665 Implantable polymeric device for sustained release of buprenorphine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2016
Apr 25, 2024 U-1878: For opioid dependence

Analgesics:Opioid Analgesics, Long-acting
QDOLO (SOLUTION) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ATHENA      NDA No.:
214044  Prod. No.: 001 RX (5MG/ML)
Patents Expiration Patented Use
Pat. No. 11103452 DP* Tramadol hydrochloride solution
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2021
Sep 1, 2040 U-3197: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

Analgesics:Opioid Analgesics, Long-acting
ROXYBOND (TABLET) (ORAL) OXYCODONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PROTEGA PHARMS      NDA No.:
209777  Prod. No.: 001 RX (5MG); 002 RX (15MG); 003 RX (30MG)
Patents Expiration Patented Use
Pat. No. 7955619 DP* Abuse resistant drugs, method of use and method of making
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): All strengths: May 19, 2017
Aug 12, 2028  
Pat. No. 10314788 DP* Pharmaceutical compositions configured to deter dosage form splitting
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 10, 2019
Aug 12, 2028  

Analgesics:Opioid Analgesics, Long-acting
RYZOLT (TABLET, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA      NDA No.:
021745  Prod. No.: 001 DISC (100MG**); 002 DISC (200MG**); 003 DISC (300MG**)
Patents Expiration Patented Use
Pat. No. 7988998 DP* Sustained-release tramadol formulations with 24-hour efficacy
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None
Oct 27, 2023  

Analgesics:Opioid Analgesics, Long-acting
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:Opioid Analgesics, Long-acting
SUBLOCADE (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence
NDA Applicant: INDIVIOR INC      NDA No.:
209819  Prod. No.: 001 RX (100MG/0.5ML (100MG/0.5ML))
Patents Expiration Patented Use
Pat. No. 8921387 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Dec 13, 2017
Jan 6, 2032 U-2173: Treating opioid dependence by administering buprenorphine
U-2174: Treating opioid dependency by administering buprenorphine once per month
Pat. No. 8975270 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 13, 2017
Sep 5, 2031 U-2175: Treating opioid dependency by administering buprenorphine once monthly
U-2206: Treating opioid dependency by administering buprenorphine
Pat. No. 9272044 Injectable flowable composition buprenorphine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 13, 2017
Jun 6, 2031 U-2176: Treating opioid addiction by administering buprenorphine
U-2177: Treating opioid addiction by subcutaneous injection of buprenorphine
U-2178: Treating opioid addiction by administering buprenorphine composition with 28 day dose duration
U-2209: Treating opioid addiction by administering buprenorphine once per month
Pat. No. 9498432 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Formulation; Process; Kit; Drug in a container
Pat. Sub. Date(s): 001: Dec 13, 2017
Jun 6, 2031 U-2179: In situ formation of solid buprenorphine composition
Pat. No. 9782402 DP* Injectable composition comprising buprenorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 13, 2017
Jun 6, 2031 U-2176: Treating opioid addiction by administering buprenorphine
U-2180: Treating addiction with 100 mg or 300 mg dose of buprenorphine
U-2207: Treating addiction by subcutaneous injection of buprenorphine
U-2208: Treating addiction by once per month administration of buprenorphine
Pat. No. 9827241 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: Dec 13, 2017
Jun 6, 2031 U-2174: Treating opioid dependency by administering buprenorphine once per month
U-2181: Treating opioid dependency by subcutaneously administering buprenorphine
U-2206: Treating opioid dependency by administering buprenorphine
U-2210: Treating opioid addiction by 100 mg or 300 mg dose buprenorphine
U-2211: Treating opioid addiction by administration of buprenorphine
Pat. No. 10198218 Injectable flowable composition comprising buprenorphine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 15, 2019
Jun 6, 2031 U-2489: Treatment of moderate to severe opioid use disorder
Pat. No. 10558394 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Feb 18, 2020
Jun 25, 2031  
Pat. No. 10592168 Injectable flowable composition comprising buprenorphine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 19, 2020
Jun 6, 2031 U-2489: Treatment of moderate to severe opioid use disorder
Pat. No. 11000520 Buprenorphine dosing regimens
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 20, 2021
Nov 6, 2035 U-3111: Treating opioid use disorder

Analgesics:Opioid Analgesics, Long-acting
SUBLOCADE (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence
NDA Applicant: INDIVIOR INC      NDA No.:
209819  Prod. No.: 002 RX (300MG/1.5ML (200MG/ML))
Patents Expiration Patented Use
Pat. No. 8921387 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 002: Dec 13, 2017
Jan 6, 2032 U-2173: Treating opioid dependence by administering buprenorphine
U-2174: Treating opioid dependency by administering buprenorphine once per month
Pat. No. 8975270 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Dec 13, 2017
Sep 5, 2031 U-2175: Treating opioid dependency by administering buprenorphine once monthly
U-2206: Treating opioid dependency by administering buprenorphine
Pat. No. 9272044 Injectable flowable composition buprenorphine
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 13, 2017
Jun 6, 2031 U-2176: Treating opioid addiction by administering buprenorphine
U-2177: Treating opioid addiction by subcutaneous injection of buprenorphine
U-2178: Treating opioid addiction by administering buprenorphine composition with 28 day dose duration
U-2209: Treating opioid addiction by administering buprenorphine once per month
Pat. No. 9498432 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Formulation; Process; Kit; Drug in a container
Pat. Sub. Date(s): 002: Dec 13, 2017
Jun 6, 2031 U-2179: In situ formation of solid buprenorphine composition
Pat. No. 9782402 DP* Injectable composition comprising buprenorphine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Dec 13, 2017
Jun 6, 2031 U-2176: Treating opioid addiction by administering buprenorphine
U-2180: Treating addiction with 100 mg or 300 mg dose of buprenorphine
U-2207: Treating addiction by subcutaneous injection of buprenorphine
U-2208: Treating addiction by once per month administration of buprenorphine
Pat. No. 9827241 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 002: Dec 13, 2017
Jun 6, 2031 U-2174: Treating opioid dependency by administering buprenorphine once per month
U-2181: Treating opioid dependency by subcutaneously administering buprenorphine
U-2206: Treating opioid dependency by administering buprenorphine
U-2210: Treating opioid addiction by 100 mg or 300 mg dose buprenorphine
U-2211: Treating opioid addiction by administration of buprenorphine
Pat. No. 10198218 Injectable flowable composition comprising buprenorphine
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 15, 2019
Jun 6, 2031 U-2489: Treatment of moderate to severe opioid use disorder
Pat. No. 10558394 DP* Injectable flowable composition comprising buprenorphine
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 002: Jul 16, 2020
Jun 25, 2031  
Pat. No. 10592168 Injectable flowable composition comprising buprenorphine
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 19, 2020
Jun 6, 2031 U-2489: Treatment of moderate to severe opioid use disorder
Pat. No. 10646484 Methods to treat opioid use disorder
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 12, 2020
Jun 22, 2038 U-2489: Treatment of moderate to severe opioid use disorder
Pat. No. 11000520 Buprenorphine dosing regimens
Claim Types: Method of use
Pat. Sub. Date(s): 002: May 20, 2021
Nov 6, 2035 U-3111: Treating opioid use disorder

Analgesics:Opioid Analgesics, Long-acting
SUBOXONE (FILM) (BUCCAL, SUBLINGUAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE [GENERIC AB]
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: INDIVIOR INC      NDA No.:
022410  Prod. No.: 001 RX (EQ 2MG BASE;EQ 0.5MG BASE); 002 RX (EQ 8MG BASE;EQ 2MG BASE); 003 RX (EQ 4MG BASE;EQ 1MG BASE); 004 RX (EQ 12MG BASE;EQ 3MG BASE)
Patents Expiration Patented Use
Pat. No. 8017150 DP* Polyethylene oxide-based films and drug delivery systems made therefrom
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 4, 2011; 002: None; 003: None; 004: None
Feb 13, 2023  
Pat. No. 8475832 DP* Sublingual and buccal film compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 3, 2013; 002: None; 003: None; 004: None
Mar 26, 2030 U-1411: This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Apr 3, 2024 U-1464: Treatment of opioid dependence/sublingual or buccal application
Pat. No. 9687454 DP* Sublingual and buccal film compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 14, 2017
Aug 7, 2029 U-1464: Treatment of opioid dependence/sublingual or buccal application
Pat. No. 11135216 DP* Sublingual and buccal film compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 21, 2021
Aug 7, 2029 U-3111: Treating opioid use disorder

Analgesics:Opioid Analgesics, Long-acting
SUBSYS (SPRAY) (SUBLINGUAL) FENTANYL
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
202788  Prod. No.: 001 DISC (0.1MG); 003 DISC (0.4MG); 004 DISC (0.6MG); 006 DISC (1.2MG); 007 DISC (1.6MG)
Patents Expiration Patented Use
Pat. No. 8486972 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 30, 2013
Apr 27, 2030  
Pat. No. 8486973 Sublingual fentanyl spray
Claim Types: Method of use; Method of administration; Process
Pat. Sub. Date(s): All strengths: Jul 30, 2013
Apr 27, 2030 U-55: Treatment of pain
Pat. No. 8835459 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 24, 2014
Jan 25, 2027  
Pat. No. 8835460 DP* Sublingual fentanyl spray and methods of treating pain
Claim Types: Formulation; Device; Method of use
Pat. Sub. Date(s): 001: Sep 24, 2014; 003: Sep 24, 2014; 004: Sep 24, 2014; 006: Sep 24, 2014; 007: Sep 29, 2014
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9241935 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 18, 2016
Jan 25, 2027  
Pat. No. 9289387 DP* Method of treating pain by administering sublingual fentanyl spray
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642797 DP* Sublingual fentanyl spray and methods of use to treat pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642844 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 15, 2017
Jan 25, 2027  
Pat. No. 10016403 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 10, 2018
Jan 25, 2027  
Pat. No. 10610523 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 22, 2020; 003: Apr 22, 2020; 004: Apr 22, 2020; 006: May 6, 2020; 007: May 6, 2020
Jan 25, 2027  

Analgesics:Opioid Analgesics, Long-acting
SUBSYS (SPRAY) (SUBLINGUAL) FENTANYL
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
202788  Prod. No.: 002 DISC (0.2MG)
Patents Expiration Patented Use
Pat. No. 8486972 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jul 30, 2013
Apr 27, 2030  
Pat. No. 8486973 Sublingual fentanyl spray
Claim Types: Method of use; Method of administration; Process
Pat. Sub. Date(s): 002: Jul 30, 2013
Apr 27, 2030 U-55: Treatment of pain
Pat. No. 8835460 DP* Sublingual fentanyl spray and methods of treating pain
Claim Types: Formulation; Device; Method of use
Pat. Sub. Date(s): 002: Sep 29, 2014
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9241935 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 18, 2016
Jan 25, 2027  
Pat. No. 9289387 DP* Method of treating pain by administering sublingual fentanyl spray
Claim Types: Method of administration
Pat. Sub. Date(s): 002: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642797 DP* Sublingual fentanyl spray and methods of use to treat pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642844 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 15, 2017
Jan 25, 2027  
Pat. No. 10016403 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: Aug 10, 2018
Jan 25, 2027  
Pat. No. 10610523 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: Apr 22, 2020
Jan 25, 2027  

Analgesics:Opioid Analgesics, Long-acting
SUBSYS (SPRAY) (SUBLINGUAL) FENTANYL
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
202788  Prod. No.: 005 DISC (0.8MG)
Patents Expiration Patented Use
Pat. No. 8486972 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: Jul 30, 2013
Apr 27, 2030  
Pat. No. 8486973 Sublingual fentanyl spray
Claim Types: Method of use; Method of administration; Process
Pat. Sub. Date(s): 005: Jul 30, 2013
Apr 27, 2030 U-55: Treatment of pain
Pat. No. 8835460 DP* Sublingual fentanyl spray and methods of treating pain
Claim Types: Formulation; Device; Method of use
Pat. Sub. Date(s): 005: Sep 24, 2014
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9241935 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: Feb 18, 2016
Jan 25, 2027  
Pat. No. 9289387 DP* Method of treating pain by administering sublingual fentanyl spray
Claim Types: Method of administration
Pat. Sub. Date(s): 005: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642797 DP* Sublingual fentanyl spray and methods of use to treat pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 005: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642844 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: May 15, 2017
Jan 25, 2027  
Pat. No. 10016403 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: Aug 10, 2018
Jan 25, 2027  
Pat. No. 10610523 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: Apr 22, 2020
Jan 25, 2027  

Analgesics:Opioid Analgesics, Long-acting
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA LP      NDA No.:
205777  Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
Patents Expiration Patented Use
Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 30, 2014
Apr 4, 2023  
Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 30, 2014
Apr 4, 2023  
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025  
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025  
Pat. No. 9555000 DP* Pharmaceutical preparation containing oxycodone and naloxone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 1, 2017
Apr 4, 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. 9907793 DP* Pharmaceutical preparation containing oxycodone and naloxone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Apr 4, 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.

Analgesics:Opioid Analgesics, Long-acting
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA LP      NDA No.:
205777  Prod. No.: 003 DISC (20MG;40MG)
Patents Expiration Patented Use
Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): 003: Sep 30, 2014
Apr 4, 2023  
Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): 003: Sep 30, 2014
Apr 4, 2023  
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: Aug 3, 2015
Mar 30, 2025  
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): 003: Dec 20, 2016
Mar 30, 2025  

Analgesics:Opioid Analgesics, Long-acting
TROXYCA ER (CAPSULE, EXTENDED RELEASE) (ORAL) NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PFIZER      NDA No.:
207621  Prod. No.: 001 DISC (1.2MG;10MG); 002 DISC (2.4MG;20MG); 003 DISC (3.6MG;30MG); 004 DISC (4.8MG;40MG); 005 DISC (7.2MG;60MG); 006 DISC (9.6MG;80MG)
Patents Expiration Patented Use
Pat. No. 7815934 DP* Sequestering subunit and related compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 16, 2016
Dec 12, 2027  
Pat. No. 8685443 Sequestering subunit and related compositions and methods
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 16, 2016
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

Analgesics:Opioid Analgesics, Long-acting
VANTRELA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
207975  Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (45MG); 004 DISC (60MG); 005 DISC (90MG)
Patents Expiration Patented Use
Pat. No. 8445018 DP* Abuse resistant drug formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 19, 2017
Jul 31, 2029  
Pat. No. 9216176 DP* Abuse resistant drug formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 19, 2017
Sep 13, 2027  
Pat. No. 9572803 DP* Abuse resistant drug formulation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 21, 2017
Sep 13, 2027  

Analgesics:Opioid Analgesics, Long-acting
XARTEMIS XR (TABLET, EXTENDED RELEASE) (ORAL) ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: MALLINCKRODT INC      NDA No.:
204031  Prod. No.: 001 DISC (325MG;7.5MG**)
Patents Expiration Patented Use
Pat. No. 7976870 Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Jun 1, 2027 U-1498: Method of treating patients with gastric retentive dosage form
Pat. No. 8372432 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Mar 11, 2029 U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8377453 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Nov 19, 2029 U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8394408 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2014
Mar 11, 2029  
Pat. No. 8597681 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Apr 3, 2014
Dec 21, 2030  
Pat. No. 8658631 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2014
May 16, 2032  
Pat. No. 8668929 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Mar 11, 2029 U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8741885 DP* Gastric retentive extended release pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 17, 2014
May 16, 2032 U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8980319 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2015
Dec 21, 2030  
Pat. No. 8992975 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2015
May 16, 2032  
Pat. No. 9050335 DP* Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
Claim Types: Formuation
Pat. Sub. Date(s): 001: Jun 25, 2015
May 16, 2032  
Pat. No. 9468636 Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2016
May 16, 2032 U-1499: Management of acute pain in patients requiring opioid analgesia

Analgesics:Opioid Analgesics, Long-acting
XTAMPZA ER (CAPSULE, EXTENDED RELEASE) (ORAL) OXYCODONE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: COLLEGIUM PHARM INC      NDA No.:
208090  Prod. No.: 001 RX (9MG); 002 RX (13.5MG); 003 RX (18MG); 004 RX (27MG); 005 RX (36MG)
Patents Expiration Patented Use
Pat. No. 7399488 DP* Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 24, 2025  
Pat. No. 7771707 DP* Abuse-deterrent drug formulations
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 24, 2025  
Pat. No. 8449909 DP* Abuse-deterrent drug formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 24, 2025  
Pat. No. 8557291 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 21, 2025  
Pat. No. 8758813 Abuse-deterrent drug formulations
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Jun 10, 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. 8840928 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Jul 7, 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. 9044398 DP* Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Jul 7, 2023  
Pat. No. 9248195 Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Jul 7, 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. 9592200 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Mar 20, 2017
Jul 7, 2023  
Pat. No. 9682075 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 20, 2017
Dec 10, 2030 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. 9737530 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Product-by-process; Method of use; Process
Pat. Sub. Date(s): All strengths: Aug 23, 2017
Sep 2, 2036 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. 9763883 DP* Abuse-deterrent drug formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 20, 2017
Jul 7, 2023  
Pat. No. 9968598 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Product-by-process; Process; Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 16, 2018
Sep 2, 2036 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. 10004729 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Jul 10, 2018
Dec 10, 2030 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. 10188644 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Method of use of a product-by-process; Product-by-process
Pat. Sub. Date(s): All strengths: Jan 29, 2019
Sep 2, 2036 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. 10525052 DP* Abuse-deterrent drug formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jan 7, 2020
Jul 7, 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. 10525053 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 7, 2020
Jul 7, 2023  
Pat. No. 10646485 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: May 13, 2020
Sep 2, 2036 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. 10668060 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 3, 2020
Dec 10, 2030 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
ZOHYDRO ER (CAPSULE, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough
NDA Applicant: RECRO GAINESVILLE      NDA No.:
202880  Prod. No.: 001 DISC (10MG ); 002 DISC (15MG ); 003 DISC (20MG); 004 DISC (30MG ); 005 DISC (40MG); 006 DISC (50MG )
Patents Expiration Patented Use
Pat. No. 9132096 DP* Abuse resistant pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 22, 2015
Sep 12, 2034  
Pat. No. 9265760 Treating pain in patients with hepatic impairment
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Feb 23, 2016
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9326982 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 4, 2016
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9333201 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 18, 2016
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9339499 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 18, 2016
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9421200 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 7, 2016
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9433619 Treating pain in patients with hepatic impairment
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 7, 2016
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9452163 Abuse resistant pharmaceutical compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 11, 2016
Sep 12, 2034 U-55: Treatment of pain
Pat. No. 9486451 Abuse resistant pharmaceutical compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 12, 2017
Sep 12, 2034 U-55: Treatment of pain
Pat. No. 9610286 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 5, 2017
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 9713611 DP* Abuse resistant pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 23, 2017
Sep 12, 2034 U-55: Treatment of pain
Pat. No. 10028946 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 27, 2018
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 10092559 Abuse resistant pharmaceutical compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 13, 2018
Sep 12, 2034 U-55: Treatment of pain
Pat. No. 10322120 DP* Treating pain in patients with hepatic impairment
Claim Types: Kit
Pat. Sub. Date(s): All strengths: Jul 17, 2019
Jul 25, 2033  
Pat. No. 10456393 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 29, 2019
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment
Pat. No. 10722511 Treating pain in patients with hepatic impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 25, 2020
Jul 25, 2033 U-1810: Treatment of pain in patients with hepatic impairment

Analgesics:Opioid Analgesics, Long-acting
ZUBSOLV (TABLET) (SUBLINGUAL) 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: OREXO US INC      NDA No.:
204242  Prod. No.: 001 RX (EQ 1.4MG BASE;EQ 0.36MG BASE)
Patents Expiration Patented Use
Pat. No. 8470361 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 10, 2013
May 22, 2030 U-1425: Sublingual administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8658198 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: New polymorph, salt or hydrate; Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: Mar 25, 2014
Dec 3, 2027 U-1494: Sublingual or buccal administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8940330 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Feb 5, 2015
Sep 18, 2032  
Pat. No. 9259421 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 10, 2016
Sep 18, 2032  
Pat. No. 9439900 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 3, 2016
Sep 18, 2032  
Pat. No. 10946010 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 30, 2021
Sep 18, 2032  
Pat. No. 11020388 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): 001: Jun 21, 2021
Sep 18, 2032 U-3131: Use of ZUBSOLV for treatment of opioid dependence
Pat. No. 11433066 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 20, 2022
Sep 18, 2032 U-3131: Use of ZUBSOLV for treatment of opioid dependence

Analgesics:Opioid Analgesics, Long-acting
ZUBSOLV (TABLET) (SUBLINGUAL) 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: OREXO US INC      NDA No.:
204242  Prod. No.: 002 RX (EQ 5.7MG BASE;EQ 1.4MG BASE)
Patents Expiration Patented Use
Pat. No. 8470361 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Jul 10, 2013
May 22, 2030 U-1425: Sublingual administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8658198 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: New polymorph, salt or hydrate; Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 002: Mar 25, 2014
Dec 3, 2027 U-1494: Sublingual or buccal administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8940330 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation; Process
Pat. Sub. Date(s): 002: Feb 5, 2015
Sep 18, 2032  
Pat. No. 9259421 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 10, 2016
Sep 18, 2032  
Pat. No. 9439900 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 002: Oct 3, 2016
Sep 18, 2032  
Pat. No. 10874661 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jan 25, 2021
Sep 18, 2032  
Pat. No. 10946010 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 002: Mar 30, 2021
Sep 18, 2032  
Pat. No. 11020387 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Jun 21, 2021
Sep 18, 2032 U-3131: Use of ZUBSOLV for treatment of opioid dependence
Pat. No. 11020388 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): 002: Jun 21, 2021
Sep 18, 2032 U-3131: Use of ZUBSOLV for treatment of opioid dependence
Pat. No. 11433066 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 20, 2022
Sep 18, 2032 U-3131: Use of ZUBSOLV for treatment of opioid dependence

Analgesics:Opioid Analgesics, Long-acting
ZUBSOLV (TABLET) (SUBLINGUAL) 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: OREXO US INC      NDA No.:
204242  Prod. No.: 003 RX (EQ 8.6MG BASE;EQ 2.1MG BASE); 004 RX (EQ 11.4MG BASE;EQ 2.9MG BASE); 005 RX (EQ 2.9MG BASE;EQ 0.71MG BASE)
Patents Expiration Patented Use
Pat. No. 8470361 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Jul 10, 2013; 004: Jul 10, 2013; 005: Jun 29, 2015
May 22, 2030 U-1425: Sublingual administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8658198 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: New polymorph, salt or hydrate; Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 003: None; 004: Jan 9, 2015; 005: Jun 29, 2015
Dec 3, 2027 U-1494: Sublingual or buccal administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8940330 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: Feb 5, 2015; 004: Feb 5, 2015; 005: Jun 29, 2015
Sep 18, 2032  
Pat. No. 9259421 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 10, 2016
Sep 18, 2032  
Pat. No. 9439900 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 3, 2016
Sep 18, 2032  
Pat. No. 10946010 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 30, 2021
Sep 18, 2032  
Pat. No. 11020387 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 21, 2021
Sep 18, 2032 U-3131: Use of ZUBSOLV for treatment of opioid dependence
Pat. No. 11020388 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): All strengths: Jun 21, 2021
Sep 18, 2032 U-3131: Use of ZUBSOLV for treatment of opioid dependence
Pat. No. 11433066 Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 20, 2022
Sep 18, 2032 U-3131: Use of ZUBSOLV for treatment of opioid dependence

Analgesics:Opioid Analgesics, Long-acting
ZUBSOLV (TABLET) (SUBLINGUAL) 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: OREXO US INC      NDA No.:
204242  Prod. No.: 006 RX (EQ 0.7MG BASE;EQ 0.18MG BASE)
Patents Expiration Patented Use
Pat. No. 8470361 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 006: Oct 26, 2016
May 22, 2030 U-1425: Sublingual administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8658198 DP* Non-abusable pharmaceutical composition comprising opioids
Claim Types: New polymorph, salt or hydrate; Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 006: Oct 26, 2016
Dec 3, 2027 U-1494: Sublingual or buccal administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8940330 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation; Process
Pat. Sub. Date(s): 006: Oct 26, 2016
Sep 18, 2032  
Pat. No. 9259421 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 006: Oct 26, 2016
Sep 18, 2032  
Pat. No. 9439900 DP* DLR* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 006: Oct 26, 2016
Sep 18, 2032  
Pat. No. 10946010 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation
Pat. Sub. Date(s): 006: Mar 30, 2021
Sep 18, 2032  
Pat. No. 11020388 DP* Abuse-resistant pharmaceutical composition for the treatment of opioid dependence
Claim Types: Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): 006: Jun 21, 2021
Sep 18, 2032 U-3131: Use of ZUBSOLV for treatment of opioid dependence

Analgesics:Opioid Analgesics, Short-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, Short-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, Short-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, Short-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, Short-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, Short-acting
IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: THE MEDICINES CO      NDA No.:
021338  Prod. No.: 001 DISC (EQ 40MCG BASE/ACTIVATION)
Patents Expiration Patented Use
Pat. No. 6975902 DP* Reservoir and a series of related reservoirs for use in an electrotransport drug delivery device and devices comprised thereof
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 1, 2024  
Pat. No. 8301238 DP* Two-part electrotransport device
Claim Types: Device
Pat. Sub. Date(s): 001: None
Sep 30, 2031  
Pat. No. 8428708 Self-test for analgesic product
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: None
May 21, 2032 U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8428709 DP* Current control for electrotransport drug delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: May 28, 2015
Jun 11, 2032 U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 8781571 DP* Switch validation circuit and method
Claim Types: Device; Method of improving a treatment
Pat. Sub. Date(s): 001: May 28, 2015
Mar 31, 2032 U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9095706 DP* Self-test for analgesic product
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 3, 2033  
Pat. No. 9364656 Method of storing an electrotransport drug delivery device
Claim Types: Process
Pat. Sub. Date(s): 001: Jun 21, 2016
Sep 30, 2031 U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
Pat. No. 9731121 DP* Switch validation circuit and method
Claim Types: Device
Pat. Sub. Date(s): 001: Sep 12, 2017
Oct 17, 2031  

Analgesics:Opioid Analgesics, Short-acting
LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
022569  Prod. No.: 001 DISC (EQ 0.1MG BASE); 002 DISC (EQ 0.4MG BASE)
Patents Expiration Patented Use
Pat. No. 8216604 Method of managing or treating pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 19, 2012; 002: None
Oct 3, 2024 U-767: Management of breakthrough pain in patients with cancer
Pat. No. 8889176 Method of managing or treating pain
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Dec 12, 2014
Jan 16, 2024 U-767: Management of breakthrough pain in patients with cancer
Pat. No. 9078814 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Drug in a container
Pat. Sub. Date(s): All strengths: Aug 11, 2015
Jan 8, 2024  
Pat. No. 9731869 DP* Container
Claim Types: Packaging or device material
Pat. Sub. Date(s): All strengths: Sep 1, 2017
Jan 26, 2032  
Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 13, 2017
Jan 8, 2024  

Analgesics:Opioid Analgesics, Short-acting
LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
022569  Prod. No.: 003 DISC (EQ 0.3MG BASE)
Patents Expiration Patented Use
Pat. No. 9731869 DP* Container
Claim Types: Packaging or device material
Pat. Sub. Date(s): 003: Sep 1, 2017
Jan 26, 2032  
Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 13, 2017
Jan 8, 2024  

Analgesics:Opioid Analgesics, Short-acting
MORPHABOND ER (TABLET, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: DAIICHI SANKYO INC      NDA No.:
206544  Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG); 004 DISC (100MG)
Patents Expiration Patented Use
Pat. No. 7955619 DP* Abuse resistant drugs, method of use and method of making
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): All strengths: Mar 24, 2016
Aug 12, 2028  
Pat. No. 10314788 DP* Pharmaceutical compositions configured to deter dosage form splitting
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 10, 2019
Aug 12, 2028  

Analgesics:Opioid Analgesics, Short-acting
MORPHINE SULFATE (SOLUTION) (ORAL) MORPHINE SULFATE [GENERIC AA]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: HIKMA      NDA No.:
022195  Prod. No.: 001 RX (10MG/5ML); 002 RX (20MG/5ML)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NPP - New patient population Jun 2, 2024  

Analgesics:Opioid Analgesics, Short-acting
MORPHINE SULFATE (TABLET) (ORAL) MORPHINE SULFATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: HIKMA      NDA No.:
022207  Prod. No.: 001 RX (15MG); 002 RX (30MG)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NPP - New patient population Jun 2, 2024  

Analgesics:Opioid Analgesics, Short-acting
MORPHINE SULFATE (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS) MORPHINE SULFATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: FRESENIUS KABI USA      NDA No.:
204223  Prod. No.: 001 RX (2MG/ML (2MG/ML)); 002 RX (4MG/ML (4MG/ML)); 003 RX (5MG/ML (5MG/ML)); 004 RX (8MG/ML (8MG/ML)); 005 RX (10MG/ML (10MG/ML))
Patents Expiration Patented Use
Pat. No. 9072781 DP* Morphine formulations
Claim Types: Formulation; Kit
Pat. Sub. Date(s): All strengths: Jul 13, 2015
Mar 12, 2034  
Pat. No. 9192608 Morphine formulations
Claim Types: Method of use; Method of improving a treatment
Pat. Sub. Date(s): All strengths: Dec 4, 2015
Mar 12, 2034 U-43: Management of chronic pain in patients requiring opioid analgesia
U-55: Treatment of pain
Pat. No. 9248229 DP* Packaging system for oxygen-sensitive drugs
Claim Types: Drug in a container
Pat. Sub. Date(s): All strengths: Feb 17, 2016
Mar 12, 2034  

Analgesics:Opioid Analgesics, Short-acting
NUCYNTA (TABLET) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: COLLEGIUM PHARM INC      NDA No.:
022304  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE); 003 RX (EQ 100MG BASE)
Patents Expiration Patented Use
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None
Jun 27, 2025 U-931: Relief of moderate to severe acute pain

Analgesics:Opioid Analgesics, Short-acting
NUCYNTA (SOLUTION) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: COLLEGIUM PHARM INC      NDA No.:
203794  Prod. No.: 001 DISC (EQ 20MG BASE/ML)
Patents Expiration Patented Use
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Jun 27, 2025 U-1289: Management of moderate to severe acute pain

Analgesics:Opioid Analgesics, Short-acting
NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: COLLEGIUM PHARM INC      NDA No.:
200533  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE); 004 RX (EQ 200MG BASE); 005 RX (EQ 250MG BASE)
Patents Expiration Patented Use
Pat. No. 7994364 DS* DP* Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2011; 002: None; 003: None; 004: None; 005: None
Jun 27, 2025 U-1178: Relief of moderate to severe chronic pain
U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 8075872 DP* Abuse-proofed dosage form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 9, 2012; 002: None; 003: None; 004: None; 005: None
Nov 20, 2023  
Pat. No. 8114383 DP* DLR* Abuse-proofed dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 14, 2012; 002: None; 003: None; 004: None; 005: None
Oct 10, 2024  
Pat. No. 8309060 DP* Abuse-proofed dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 5, 2012; 002: None; 003: None; 004: None; 005: None
Nov 20, 2023 U-1178: Relief of moderate to severe chronic pain
U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 8420056 DP* Abuse-proofed dosage form
Claim Types: Formulation; Process; Product-by-process
Pat. Sub. Date(s): 001: May 2, 2013; 002: None; 003: None; 004: None; 005: None
Nov 20, 2023  
Pat. No. 8536130 Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Sep 22, 2028 U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 11344512 Titration of tapentadol
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 29, 2022
Apr 21, 2028 U-3391: A method of titrating an opioid to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate
U-3392: A method of titrating an opioid to manage neuropathic pain associated with diabetic peripheral neuropathy severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

Analgesics:Opioid Analgesics, Short-acting
OLINVYK (SOLUTION) (INTRAVENOUS) OLICERIDINE
Drug Classes: Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: TREVENA      NDA No.:
210730  Prod. No.: 001 RX (1MG/ML (1MG/ML)); 002 RX (2MG/2ML (1MG/ML)); 003 RX (30MG/30ML (1MG/ML))
Patents Expiration Patented Use
Pat. No. 8835488 DS* DP* Opioid receptor ligands and methods of using and making same
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Nov 20, 2020
Mar 23, 2032 U-2986: Management of acute pain by intravenous injection
Pat. No. 9309234 DS* DP* Opioid receptor ligands and methods of using and making same
Claim Types: Compound; Method of use
Pat. Sub. Date(s): All strengths: Nov 20, 2020
Mar 23, 2032 U-2986: Management of acute pain by intravenous injection
Pat. No. 9642842 DP* Opioid receptor ligands and methods of using and making same
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: Nov 20, 2020
Mar 23, 2032 U-2986: Management of acute pain by intravenous injection
Pat. No. 11077098 DS* DP* Opioid receptor ligands and methods of using and making same
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Sep 1, 2021
Mar 23, 2032 U-2986: Management of acute pain by intravenous injection
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Oct 30, 2025  

Analgesics:Opioid Analgesics, Short-acting
ONSOLIS (FILM) (BUCCAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ADALVO      NDA No.:
022266  Prod. No.: 001 DISC (EQ 0.2MG BASE); 002 DISC (EQ 0.4MG BASE); 003 DISC (EQ 0.6MG BASE); 004 DISC (EQ 0.8MG BASE); 005 DISC (EQ 1.2MG BASE)
Patents Expiration Patented Use
Pat. No. 9597288 DP* Transmucosal delivery devices with enhanced uptake
Claim Types: Method of administration; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 3, 2017
Jul 23, 2027 U-767: Management of breakthrough pain in patients with cancer

Analgesics:Opioid Analgesics, Short-acting
OPANA (TABLET) (ORAL) OXYMORPHONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ENDO PHARMS      NDA No.:
021611  Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: M - Miscellaneous Oct 25, 2022 M-14: Additional clinical trial information added to pediatric use subsection

Analgesics:Opioid Analgesics, Short-acting
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ENDO PHARMS      NDA No.:
021610  Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**); 003 DISC (20MG**); 004 DISC (40MG**); 005 DISC (7.5MG**); 006 DISC (15MG**); 007 DISC (30MG**)
Patents Expiration Patented Use
Pat. No. 7276250 DP* Sustained release formulations of oxymorphone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Feb 4, 2023 U-826: Relief of moderate to severe pain
Pat. No. 8309112 DP* Coatings for implantable medical devices comprising hydrophilic substances and methods for fabricating the same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Feb 4, 2023  
Pat. No. 8329216 DP* Oxymorphone controlled release formulations
Claim Types: Formulation; Method of use; Product-by-process
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Feb 4, 2023  
Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Jun 21, 2027 U-3085: Dose modification for renal impairment
Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 18, 2021
Nov 22, 2029  

Analgesics:Opioid Analgesics, Short-acting
OPANA ER (TABLET, EXTENDED RELEASE) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ENDO PHARMS      NDA No.:
201655  Prod. No.: 001 DISC (5MG); 002 DISC (7.5MG); 003 DISC (10MG); 004 DISC (15MG); 005 DISC (20MG); 006 DISC (30MG); 007 DISC (40MG)
Patents Expiration Patented Use
Pat. No. 7851482 DS* Method for making analgesics
Claim Types: Composition; Method of use; Process
Pat. Sub. Date(s): 001: Mar 22, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Jul 10, 2029  
Pat. No. 8075872 DP* Abuse-proofed dosage form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Dec 13, 2011; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Nov 20, 2023  
Pat. No. 8114383 DP* Abuse-proofed dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Aug 8, 2024  
Pat. No. 8192722 DP* Abuse-proof dosage form
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jun 5, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Sep 15, 2025  
Pat. No. 8309060 DP* Abuse-proofed dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Nov 20, 2023  
Pat. No. 8309122 DP* Oxymorphone controlled release formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 13, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Feb 4, 2023  
Pat. No. 8329216 DP* Oxymorphone controlled release formulations
Claim Types: Formulation; Method of use; Product-by-process
Pat. Sub. Date(s): 001: Dec 11, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None
Feb 4, 2023  
Pat. No. 8808737 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 7, 2014
Jun 21, 2027 U-1598: Method of administration of controlled release oxymorphone
Pat. No. 8871779 DS* Process for preparing morphinan-6-one products with low levels of .alpha.,.beta.-unsaturated ketone compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 7, 2014
Nov 22, 2029  

Analgesics:Opioid Analgesics, Short-acting
OXAYDO (TABLET) (ORAL) OXYCODONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ZYLA      NDA No.:
202080  Prod. No.: 001 RX (5MG); 002 RX (7.5MG)
Patents Expiration Patented Use
Pat. No. 7201920 DP* Methods and compositions for deterring abuse of opioid containing dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 14, 2011
Mar 16, 2025  
Pat. No. 7510726 DP* Methods and compositions for deterring abuse of opioid containing dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 14, 2011
Nov 26, 2023  
Pat. No. 7981439 DP* Methods and compositions for deterring abuse of drugs susceptible to abuse and dosage forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 9, 2011; 002: None
Nov 26, 2023  
Pat. No. 8409616 DP* Extended release opioid abuse deterrent compositions and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Nov 26, 2023  
Pat. No. 8637540 DP* Compositions for deterring abuse of opioid containing dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 20, 2014
Nov 26, 2023  
Pat. No. 9492443 DP* Abuse deterrent compositions and methods of making same
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 18, 2016
May 26, 2024  

Analgesics:Opioid Analgesics, Short-acting
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA LP      NDA No.:
022272  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG)
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 14, 2012
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. 8808741 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 19, 2014
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. 8894987 DP* Tamper resistant dosage forms
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Mar 29, 2030  
Pat. No. 8894988 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Aug 24, 2027  
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025  
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. 9492391 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 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. 9492392 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027  
Pat. No. 9492393 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 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. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025  
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. 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. 9775808 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 4, 2017
Aug 24, 2027  
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. 10407434 DS* Process for preparing oxycodone compositions
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Mar 30, 2025  
Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 10, 2020
Nov 20, 2023  
Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Product-by-process; Composition
Pat. Sub. Date(s): All strengths: Jun 30, 2020
Mar 30, 2025  
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.

Analgesics:Opioid Analgesics, Short-acting
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA LP      NDA No.:
022272  Prod. No.: 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
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 14, 2012
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. 8808741 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 19, 2014
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. 8894988 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 25, 2014
Aug 24, 2027  
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025  
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. 9492391 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 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. 9492392 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 16, 2016
Aug 24, 2027  
Pat. No. 9492393 Tamper resistant dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 16, 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. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025  
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. 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. 9775808 DP* Tamper resistant dosage forms
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 4, 2017
Aug 24, 2027  
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. 10407434 DS* Process for preparing oxycodone compositions
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Mar 30, 2025  
Pat. No. 10675278 DP* Crush resistant delayed-release dosage forms
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jun 10, 2020
Nov 20, 2023  
Pat. No. 10696684 DS* Process for preparing oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Product-by-process; Composition
Pat. Sub. Date(s): All strengths: Jun 30, 2020
Mar 30, 2025  
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.

Analgesics:Opioid Analgesics, Short-acting
QDOLO (SOLUTION) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ATHENA      NDA No.:
214044  Prod. No.: 001 RX (5MG/ML)
Patents Expiration Patented Use
Pat. No. 11103452 DP* Tramadol hydrochloride solution
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2021
Sep 1, 2040 U-3197: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

Analgesics:Opioid Analgesics, Short-acting
ROXYBOND (TABLET) (ORAL) OXYCODONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PROTEGA PHARMS      NDA No.:
209777  Prod. No.: 001 RX (5MG); 002 RX (15MG); 003 RX (30MG)
Patents Expiration Patented Use
Pat. No. 7955619 DP* Abuse resistant drugs, method of use and method of making
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): All strengths: May 19, 2017
Aug 12, 2028  
Pat. No. 10314788 DP* Pharmaceutical compositions configured to deter dosage form splitting
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 10, 2019
Aug 12, 2028  

Analgesics:Opioid Analgesics, Short-acting
RYZOLT (TABLET, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA      NDA No.:
021745  Prod. No.: 001 DISC (100MG**); 002 DISC (200MG**); 003 DISC (300MG**)
Patents Expiration Patented Use
Pat. No. 7988998 DP* Sustained-release tramadol formulations with 24-hour efficacy
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None
Oct 27, 2023  

Analgesics:Opioid Analgesics, Short-acting
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:Opioid Analgesics, Short-acting
SUBSYS (SPRAY) (SUBLINGUAL) FENTANYL
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
202788  Prod. No.: 001 DISC (0.1MG); 003 DISC (0.4MG); 004 DISC (0.6MG); 006 DISC (1.2MG); 007 DISC (1.6MG)
Patents Expiration Patented Use
Pat. No. 8486972 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 30, 2013
Apr 27, 2030  
Pat. No. 8486973 Sublingual fentanyl spray
Claim Types: Method of use; Method of administration; Process
Pat. Sub. Date(s): All strengths: Jul 30, 2013
Apr 27, 2030 U-55: Treatment of pain
Pat. No. 8835459 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 24, 2014
Jan 25, 2027  
Pat. No. 8835460 DP* Sublingual fentanyl spray and methods of treating pain
Claim Types: Formulation; Device; Method of use
Pat. Sub. Date(s): 001: Sep 24, 2014; 003: Sep 24, 2014; 004: Sep 24, 2014; 006: Sep 24, 2014; 007: Sep 29, 2014
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9241935 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 18, 2016
Jan 25, 2027  
Pat. No. 9289387 DP* Method of treating pain by administering sublingual fentanyl spray
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642797 DP* Sublingual fentanyl spray and methods of use to treat pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642844 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 15, 2017
Jan 25, 2027  
Pat. No. 10016403 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 10, 2018
Jan 25, 2027  
Pat. No. 10610523 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 22, 2020; 003: Apr 22, 2020; 004: Apr 22, 2020; 006: May 6, 2020; 007: May 6, 2020
Jan 25, 2027  

Analgesics:Opioid Analgesics, Short-acting
SUBSYS (SPRAY) (SUBLINGUAL) FENTANYL
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
202788  Prod. No.: 002 DISC (0.2MG)
Patents Expiration Patented Use
Pat. No. 8486972 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jul 30, 2013
Apr 27, 2030  
Pat. No. 8486973 Sublingual fentanyl spray
Claim Types: Method of use; Method of administration; Process
Pat. Sub. Date(s): 002: Jul 30, 2013
Apr 27, 2030 U-55: Treatment of pain
Pat. No. 8835460 DP* Sublingual fentanyl spray and methods of treating pain
Claim Types: Formulation; Device; Method of use
Pat. Sub. Date(s): 002: Sep 29, 2014
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9241935 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 18, 2016
Jan 25, 2027  
Pat. No. 9289387 DP* Method of treating pain by administering sublingual fentanyl spray
Claim Types: Method of administration
Pat. Sub. Date(s): 002: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642797 DP* Sublingual fentanyl spray and methods of use to treat pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642844 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 15, 2017
Jan 25, 2027  
Pat. No. 10016403 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: Aug 10, 2018
Jan 25, 2027  
Pat. No. 10610523 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 002: Apr 22, 2020
Jan 25, 2027  

Analgesics:Opioid Analgesics, Short-acting
SUBSYS (SPRAY) (SUBLINGUAL) FENTANYL
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: BTCP PHARMA      NDA No.:
202788  Prod. No.: 005 DISC (0.8MG)
Patents Expiration Patented Use
Pat. No. 8486972 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: Jul 30, 2013
Apr 27, 2030  
Pat. No. 8486973 Sublingual fentanyl spray
Claim Types: Method of use; Method of administration; Process
Pat. Sub. Date(s): 005: Jul 30, 2013
Apr 27, 2030 U-55: Treatment of pain
Pat. No. 8835460 DP* Sublingual fentanyl spray and methods of treating pain
Claim Types: Formulation; Device; Method of use
Pat. Sub. Date(s): 005: Sep 24, 2014
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9241935 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: Feb 18, 2016
Jan 25, 2027  
Pat. No. 9289387 DP* Method of treating pain by administering sublingual fentanyl spray
Claim Types: Method of administration
Pat. Sub. Date(s): 005: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642797 DP* Sublingual fentanyl spray and methods of use to treat pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 005: May 15, 2017
Jan 25, 2027 U-55: Treatment of pain
Pat. No. 9642844 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: May 15, 2017
Jan 25, 2027  
Pat. No. 10016403 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: Aug 10, 2018
Jan 25, 2027  
Pat. No. 10610523 DP* Sublingual fentanyl spray
Claim Types: Formulation
Pat. Sub. Date(s): 005: Apr 22, 2020
Jan 25, 2027  

Analgesics:Opioid Analgesics, Short-acting
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA LP      NDA No.:
205777  Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
Patents Expiration Patented Use
Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 30, 2014
Apr 4, 2023  
Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 30, 2014
Apr 4, 2023  
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Aug 3, 2015
Mar 30, 2025  
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2016
Mar 30, 2025  
Pat. No. 9555000 DP* Pharmaceutical preparation containing oxycodone and naloxone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Feb 1, 2017
Apr 4, 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. 9907793 DP* Pharmaceutical preparation containing oxycodone and naloxone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Apr 4, 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.

Analgesics:Opioid Analgesics, Short-acting
TARGINIQ (TABLET, EXTENDED RELEASE) (ORAL) NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PURDUE PHARMA LP      NDA No.:
205777  Prod. No.: 003 DISC (20MG;40MG)
Patents Expiration Patented Use
Pat. No. 8846090 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): 003: Sep 30, 2014
Apr 4, 2023  
Pat. No. 8846091 DP* Matrix for sustained, invariant and independent release of active compounds
Claim Types: Formulation
Pat. Sub. Date(s): 003: Sep 30, 2014
Apr 4, 2023  
Pat. No. 9073933 DS* Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: Aug 3, 2015
Mar 30, 2025  
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): 003: Dec 20, 2016
Mar 30, 2025  

Analgesics:Opioid Analgesics, Short-acting
TROXYCA ER (CAPSULE, EXTENDED RELEASE) (ORAL) NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: PFIZER      NDA No.:
207621  Prod. No.: 001 DISC (1.2MG;10MG); 002 DISC (2.4MG;20MG); 003 DISC (3.6MG;30MG); 004 DISC (4.8MG;40MG); 005 DISC (7.2MG;60MG); 006 DISC (9.6MG;80MG)
Patents Expiration Patented Use
Pat. No. 7815934 DP* Sequestering subunit and related compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 16, 2016
Dec 12, 2027  
Pat. No. 8685443 Sequestering subunit and related compositions and methods
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 16, 2016
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

Analgesics:Opioid Analgesics, Short-acting
TUXARIN ER (TABLET, EXTENDED RELEASE) (ORAL) CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE
Drug Classes: Analgesics:Opioid Analgesics, Short-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough
NDA Applicant: MAINPOINTE      NDA No.:
206323  Prod. No.: 001 RX (8MG;54.3MG)
Patents Expiration Patented Use
Pat. No. 9066942 Oral dosage forms for oxygen-containing active agents and oxyl-containing polymer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 20, 2015
Jan 3, 2032 U-1716: Treatment of cough and symptoms associated with upper respiratory allergies or a common cold with codeine phosphate and chlorpheniramine maleate orally administered extended release tablets
Pat. No. 9107921 DP* Oral dosage forms for oxygen containing active agents and oxyl-containing polymers
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 17, 2015
Jan 3, 2032  

Analgesics:Opioid Analgesics, Short-acting
TUZISTRA XR (SUSPENSION, EXTENDED RELEASE) (ORAL) CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX
Drug Classes: Analgesics:Opioid Analgesics, Short-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough
NDA Applicant: TRIS PHARMA INC      NDA No.:
207768  Prod. No.: 001 DISC (EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML)
Patents Expiration Patented Use
Pat. No. 8062667 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 1, 2015
Mar 29, 2029  
Pat. No. 8790700 DP* Modified release formulations containing drug-ion exchange resin complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 1, 2015
Mar 15, 2027  

Analgesics:Opioid Analgesics, Short-acting
XARTEMIS XR (TABLET, EXTENDED RELEASE) (ORAL) ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: MALLINCKRODT INC      NDA No.:
204031  Prod. No.: 001 DISC (325MG;7.5MG**)
Patents Expiration Patented Use
Pat. No. 7976870 Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Jun 1, 2027 U-1498: Method of treating patients with gastric retentive dosage form
Pat. No. 8372432 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Mar 11, 2029 U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8377453 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Nov 19, 2029 U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8394408 DP* Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2014
Mar 11, 2029  
Pat. No. 8597681 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Apr 3, 2014
Dec 21, 2030  
Pat. No. 8658631 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2014
May 16, 2032  
Pat. No. 8668929 Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 3, 2014
Mar 11, 2029 U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8741885 DP* Gastric retentive extended release pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 17, 2014
May 16, 2032 U-1499: Management of acute pain in patients requiring opioid analgesia
Pat. No. 8980319 DP* Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2015
Dec 21, 2030  
Pat. No. 8992975 DP* Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 3, 2015
May 16, 2032  
Pat. No. 9050335 DP* Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
Claim Types: Formuation
Pat. Sub. Date(s): 001: Jun 25, 2015
May 16, 2032  
Pat. No. 9468636 Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2016
May 16, 2032 U-1499: Management of acute pain in patients requiring opioid analgesia

Analgesics:Opioid Analgesics, Short-acting
XTAMPZA ER (CAPSULE, EXTENDED RELEASE) (ORAL) OXYCODONE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: COLLEGIUM PHARM INC      NDA No.:
208090  Prod. No.: 001 RX (9MG); 002 RX (13.5MG); 003 RX (18MG); 004 RX (27MG); 005 RX (36MG)
Patents Expiration Patented Use
Pat. No. 7399488 DP* Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 24, 2025  
Pat. No. 7771707 DP* Abuse-deterrent drug formulations
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 24, 2025  
Pat. No. 8449909 DP* Abuse-deterrent drug formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 24, 2025  
Pat. No. 8557291 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Mar 21, 2025  
Pat. No. 8758813 Abuse-deterrent drug formulations
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Jun 10, 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. 8840928 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Jul 7, 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. 9044398 DP* Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Jul 7, 2023  
Pat. No. 9248195 Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jul 19, 2016
Jul 7, 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. 9592200 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Mar 20, 2017
Jul 7, 2023  
Pat. No. 9682075 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 20, 2017
Dec 10, 2030 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. 9737530 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Product-by-process; Method of use; Process
Pat. Sub. Date(s): All strengths: Aug 23, 2017
Sep 2, 2036 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. 9763883 DP* Abuse-deterrent drug formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 20, 2017
Jul 7, 2023  
Pat. No. 9968598 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Product-by-process; Process; Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 16, 2018
Sep 2, 2036 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. 10004729 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Jul 10, 2018
Dec 10, 2030 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. 10188644 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Method of use of a product-by-process; Product-by-process
Pat. Sub. Date(s): All strengths: Jan 29, 2019
Sep 2, 2036 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. 10525052 DP* Abuse-deterrent drug formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jan 7, 2020
Jul 7, 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. 10525053 DP* Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 7, 2020
Jul 7, 2023  
Pat. No. 10646485 DP* Process of making stable abuse-deterrent oral formulations
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: May 13, 2020
Sep 2, 2036 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. 10668060 DP* Tamper-resistant pharmaceutical compositions of opioids and other drugs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 3, 2020
Dec 10, 2030 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.

Anesthetics:Local Anesthetics
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: THEA PHARMA      NDA No.:
022221  Prod. No.: 001 RX (3.5%)
Patents Expiration Patented Use
Pat. No. 8759401 DP* Aqueous gel formulation and method for inducing topical anesthesia
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 30, 2014
Jul 24, 2026 U-1523: Method of inducing topical anesthesia in the eye

Anesthetics:Local Anesthetics
EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: PACIRA PHARMS INC      NDA No.:
022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))
Patents Expiration Patented Use
Pat. No. 11033495 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: Jul 30, 2021
Jan 22,