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.
| 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 |
| 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 |
| 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
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, 2041 | U-3182: Method of providing postsurgical pain management, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11179336 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 30, 2021 | Jan 22, 2041 | U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11278494 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 4, 2022 | Jan 22, 2041 | U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11304904 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Product-by-process; Method of use Pat. Sub. Date(s): All strengths: Apr 21, 2022 | Jan 22, 2041 | U-3346: Method of providing local or regional analgesia via infiltration for local analgesia or via interscalene brachial plexus nerve block or femoral nerve block for regional analgesia |
| Pat. No. 11311486 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 27, 2022 | Jan 22, 2041 | U-3250: Method of treating pain, for example, treating postsurgical pain via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11357727 DP* Manufacturing of bupivacaine multivesicular liposomes Claim Types: Product-by-process; Method of using a product-by-process Pat. Sub. Date(s): All strengths: Jun 16, 2022 | Jan 22, 2041 | U-3380: Method of treating pain, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11426348 DP* Compositions of bupivacaine multivesicular liposomes Claim Types: Formulation claimed by its inherent performace characteristics; Method of use Pat. Sub. Date(s): All strengths: Sep 2, 2022 | Jan 22, 2041 | U-3380: Method of treating pain, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia |
| Pat. No. 11452691 DP* Compositions of bupivacaine multivesicular liposomes Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 4, 2022 | Jan 22, 2041 | U-3439: Method of treating pain, for example, via infiltration for local analgesia or via nerve block, for example, nterscalene brachial plexus for regional analgesia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Mar 22, 2024 |
Anesthetics:Local Anesthetics
PLIAGLIS (CREAM) (TOPICAL) LIDOCAINE; TETRACAINE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: TARO PHARMS NDA No.: 021717 Prod. No.: 001 RX (7%;7%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10350180 DP* Solid-forming local anesthetic formulations for pain control Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 4, 2019 | Jan 14, 2031 | |
| Pat. No. 10603293 DP* Solid-forming local anesthetic formulations for pain control Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 14, 2020 | Jan 14, 2031 | |
| Pat. No. 10751305 DP* Solid-forming topical formulations for pain control Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2020 | Jan 14, 2031 |
Anesthetics:Local Anesthetics
POSIMIR (SOLUTION, EXTENDED RELEASE) (INFILTRATION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: INNOCOLL NDA No.: 204803 Prod. No.: 001 RX (660MG/5ML (132MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8153149 DP* Controlled delivery system Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 2, 2021 | Sep 15, 2025 | |
| Pat. No. 8153661 Controlled delivery system Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 2, 2021 | Sep 15, 2025 | U-3074: Method for providing sustained local anesthesia for at least 24 hours |
| Pat. No. 8753665 DP* Controlled delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 2, 2021 | Sep 15, 2025 | U-3074: Method for providing sustained local anesthesia for at least 24 hours |
| Pat. No. 8846072 DP* Controlled delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 2, 2021 | Sep 15, 2025 | U-3074: Method for providing sustained local anesthesia for at least 24 hours |
| Pat. No. 11400019 DP* Sustained release drug delivery systems with reduced impurities and related methods Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Sep 1, 2022 | Jan 12, 2041 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 1, 2024 |
Anesthetics:Local Anesthetics
XARACOLL (IMPLANT) (IMPLANTATION) BUPIVACAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: INNOCOLL PHARMS NDA No.: 209511 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE47826 Drug delivery device for providing local analgesia, local anesthesia or nerve blockage Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 28, 2020 | May 20, 2029 | U-2949: A method for inducing a post-surgical analgesia sparing effect by implanting at the surgical site a collagen sponge containing bupivacaine HCl which provides local anesthesia for up to 24 hours following implantation |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 28, 2023 |
Anesthetics:Local Anesthetics
ZINGO (SYSTEM) (INTRADERMAL) LIDOCAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: POWDER PHARMS NDA No.: 022114 Prod. No.: 001 RX (0.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8540665 Particle cassettes and processes therefor Claim Types: Device; Process Pat. Sub. Date(s): 001: Oct 9, 2013 | Oct 22, 2029 | U-1438: Zingo intradermal injection system is a drug delivery system that is capable of delivering fine dry powdered lidocaine hydrochloride monohydrate for local anesthetic action |
| Pat. No. 9358338 Particle cassettes and processes therefor Claim Types: Device; Process Pat. Sub. Date(s): 001: Jul 6, 2016 | Apr 27, 2035 | U-1870: ZINGO is a powder intradermal system that is capable of delivering fine dry powdered lidocaine hydrochloride monohydrate for local anesthetic action |
| Pat. No. 9370622 Devices and methods for delivering particles Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 6, 2016 | Sep 28, 2035 | U-1870: ZINGO is a powder intradermal system that is capable of delivering fine dry powdered lidocaine hydrochloride monohydrate for local anesthetic action |
Anesthetics:Local Anesthetics
ZTLIDO (PATCH) (TOPICAL) LIDOCAINE
Drug Classes: Anesthetics:Local Anesthetics
NDA Applicant: SCILEX PHARMS NDA No.: 207962 Prod. No.: 001 RX (1.8%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9283174 DP* Non-aqueous patch Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 12, 2018 | May 10, 2031 | |
| Pat. No. 9925264 DP* Non-aqueous patch Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 25, 2018 | May 10, 2031 | U-2267: Method for relieving the pain associated with post-herpetic neuralgia |
| Pat. No. 9931403 DP* Non-aqueous patch Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2018 | May 10, 2031 | |
| Pat. No. 10765640 DP* Non-aqueous patch Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | May 10, 2031 | |
| Pat. No. 10765749 DP* Non-aqueous patch Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 | May 10, 2031 | |
| Pat. No. 11278623 DP* Non-aqueous patch Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 1, 2022 | May 10, 2031 |
Anesthetics:Local Anesthetics
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 |