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 |
| Pat.
No. 11613511
DS* Methods of making bempedoic acid and
compositions of the same Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 20, 2023 |
Jun 19, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 21, 2025 |
adenosine triphosphate-citrate lyase (ACL)
inhibitor
NEXLIZET
(TABLET) (ORAL)
BEMPEDOIC ACID; EZETIMIBE
Drug
Classes: adenosine triphosphate-citrate lyase (ACL)
inhibitor
NDA
Applicant: ESPERION THERAPS
INC NDA No.:
211617 Prod. No.:
001 RX (180MG;10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 7335799
DS* Hydroxyl compounds and compositions for
cholesterol management and related uses Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 6, 2020 |
Dec 3, 2025 | |
| Pat.
No. 8497301
Hydroxyl compounds and compositions for cholesterol
management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 |
Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat.
No. 9000041
Hydroxyl compounds and compositions for cholesterol
management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 |
Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat.
No. 9624152
Hydroxyl compounds and compositions for cholesterol
management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 |
Dec 23, 2023 | U-2749: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy for inhibiting cholesterol synthesis to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat.
No. 10118881
Hydroxyl compounds and compositions for cholesterol
management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 |
Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat.
No. 10912751
Fixed dose combinations and formulations comprising
ETC1002 and ezetimibe and methods of treating or
reducing the risk of cardiovascular disease Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 14, 2021 |
Mar 14, 2036 | U-3224: A method of treating heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease by decreasing the level of LDL-C using a fixed dose combination of 180 mg bempedoic acid and 10 mg ezetimibe |
| Pat.
No. 10941095
Hydroxyl compounds and compositions for cholesterol
management and related uses Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 31, 2021 |
Dec 23, 2023 | U-2746: Use of NEXLIZET as an adjunct to diet and maximally tolerated statin therapy to lower LDL-C in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease |
| Pat.
No. 11613511
DS* Methods of making bempedoic acid and
compositions of the same Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 20, 2023 |
Jun 19, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 21, 2025 | |
| Exclusivity Code: NP - New product | Feb 26, 2023 |
alkylating drug
EVOMELA
(POWDER)
(INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug
Classes: 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
HEPZATO
(POWDER)
(INTRA-ARTERIAL) MELPHALAN HYDROCHLORIDE
Drug
Classes: alkylating drug
NDA
Applicant: DELCATH SYSTEMS
INC NDA No.:
201848 Prod. No.:
001 RX (EQ 50MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 9314561
DP* Filter and frame apparatus and method of
use Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2023 |
Feb 7, 2034 | |
| Pat.
No. 9707331
DP* Apparatus for removing chemotherapy
compounds from blood Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2023 |
Sep 17, 2034 | |
| Pat.
No. 10098997
DP* Apparatus for removing chemotherapy
compounds from blood Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2023 |
Nov 7, 2032 | |
| Pat.
No. 10195334
DP* Filter and frame apparatus and method of
use Claim Types: Process Pat. Sub. Date(s): 001: Sep 6, 2023 |
Jan 16, 2033 | |
| Pat.
No. 10369264
DP* Apparatus for removing chemotherapy
compounds from blood Claim Types: Kit; Device Pat. Sub. Date(s): 001: Sep 6, 2023 |
Nov 7, 2032 | |
| Pat.
No. 11083831
DP* Filter and frame apparatus and method of
use Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2023 |
Dec 30, 2032 | |
| Pat.
No. 11241522
DP* Apparatus for removing chemotherapy
compounds from blood Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2023 |
Nov 7, 2032 | |
| Pat.
No. 11633528
DP* Apparatus for removing chemotherapy
compounds from blood Claim Types: Method of use; Device Pat. Sub. Date(s): 001: Sep 6, 2023 |
Nov 7, 2032 | U-3675: A percutaneous hepatic perfusion procedure for treating a patient with uveal melanoma with unresectable hepatic metastases |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 14, 2030 | ODE-438: As a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation |
alkylating drug
MELPHALAN
HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) MELPHALAN
HYDROCHLORIDE
Drug
Classes: alkylating drug
NDA
Applicant: APOTEX NDA No.:
217110 Prod. No.:
001 RX (EQ 90MG BASE/ML (EQ 90MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 10537520
DP* Stable liquid formulations of melphalan Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 1, 2023 |
Jun 29, 2036 |
alkylating drug
PEPAXTO
(POWDER)
(INTRAVENOUS) MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Drug
Classes: 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, 2024 | U-3093: In combination with dexamethasone to treat relapsed or refractory 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 refractory 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 refractory 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
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
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
BAQSIMI
(POWDER) (NASAL)
GLUCAGON
Drug
Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA
Applicant: ELI LILLY AND
CO NDA No.:
210134 Prod. No.:
001 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 10213487
DP* Nasal powder formulation for treatment of
hypoglycemia Claim Types: Formulation; Process; Device; Method of use Pat. Sub. Date(s): 001: Aug 23, 2019 |
Feb 16, 2036 | U-2604: Treatment of severe hypoglycemia in patients with diabetes |
| Pat.
No. 10765602
DP* Medication delivery systems and methods Claim Types: Device; Method of administration; Container Pat. Sub. Date(s): 001: Oct 8, 2020 |
Sep 23, 2039 | |
| Pat.
No. 10894133
DP* Device for dispensing a fluid product Claim Types: Device Pat. Sub. Date(s): 001: Feb 10, 2021 |
Jan 3, 2038 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Jul 24, 2022 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
BIJUVA
(CAPSULE) (ORAL)
ESTRADIOL; PROGESTERONE
Drug
Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA
Applicant: MAYNE PHARMA NDA No.:
210132 Prod. No.:
001 RX (1MG;100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 8633178
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | |
| Pat.
No. 8846648
Natural combination hormone replacement formulations
and therapies Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 8846649
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 8987237
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | |
| Pat.
No. 8993548
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | |
| Pat.
No. 8993549
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | |
| Pat.
No. 9006222
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 9114145
Natural combination hormone replacement formulations
and therapies Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 9114146
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 9301920
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 10052386
DP* Progesterone formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 19, 2018 |
Nov 21, 2032 | |
| Pat.
No. 10206932
Natural combination hormone replacement formulations
and therapies Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 11, 2019 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 10639375
DP* Progesterone formulations Claim Types: Formulation Pat. Sub. Date(s): 001: May 12, 2020 |
Nov 21, 2032 | |
| Pat.
No. 10675288
Natural combination hormone replacement formulations
and therapies Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 10, 2020 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 10806740
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 30, 2020 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 11033626
DP* Progesterone formulations having a
desirable pk profile Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 13, 2021 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 11103513
Natural combination hormone replacement formulations
and therapies Claim Types: Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Sep 23, 2021 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 11103516
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 23, 2021 |
Nov 21, 2032 | |
| Pat.
No. 11110099
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Sep 23, 2021 |
Nov 21, 2032 | |
| Pat.
No. 11529360
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 21, 2022 |
Nov 21, 2032 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
BIJUVA
(CAPSULE) (ORAL)
ESTRADIOL; PROGESTERONE
Drug
Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA
Applicant: MAYNE PHARMA NDA No.:
210132 Prod. No.:
002 DISC (0.5MG;100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 8633178
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | |
| Pat.
No. 8846648
Natural combination hormone replacement formulations
and therapies Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 8846649
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 8933059
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 8987237
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | |
| Pat.
No. 8993548
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | |
| Pat.
No. 8993549
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | |
| Pat.
No. 9114145
Natural combination hormone replacement formulations
and therapies Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 9114146
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 9301920
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 10052386
DP* Progesterone formulations Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | |
| Pat.
No. 10206932
Natural combination hormone replacement formulations
and therapies Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 10675288
Natural combination hormone replacement formulations
and therapies Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 11033626
DP* Progesterone formulations having a
desirable pk profile Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 | U-2439: Treatment of menopause symptoms, including vasomotor symptoms |
| Pat.
No. 11166963
DP* Natural combination hormone replacement
formulations and therapies Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 26, 2022 |
Nov 21, 2032 |
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
NDA
Applicant: ASSERTIO NDA No.:
022165 Prod. No.:
001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 7759394
DS* DP* Diclofenac formulations and
methods of use Claim Types: Method of administration Pat. Sub. Date(s): 001: None |
Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat.
No. 8097651
DS* DP* Diclofenac formulations and
methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: None |
Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat.
No. 8927604
Diclofenac formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2015 |
Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat.
No. 9827197
DP* Diclofenac formulations and methods of use Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 5, 2017 |
Jun 16, 2026 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
COMBOGESIC
(TABLET) (ORAL)
ACETAMINOPHEN; IBUPROFEN
Drug
Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA
Applicant: AFT PHARMS LTD NDA No.:
209471 Prod. No.:
001 DISC (325MG;97.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 10532036
Combination composition Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 29, 2023 |
Sep 22, 2025 | U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration |
| Pat.
No. 11197830
DP* Pharmaceutical composition containing
acetaminophen and ibuprofen Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2023 |
Feb 27, 2039 | U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration |
| Pat.
No. 11534407
DP* Pharmaceutical compostion containing
acetominophen and ibuprofen Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics; Method of use Pat. Sub. Date(s): 001: Mar 29, 2023 |
Feb 27, 2039 | U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 1, 2026 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
CONSENSI
(TABLET) (ORAL)
AMLODIPINE BESYLATE; CELECOXIB
Drug
Classes: 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: 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
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
INDOMETHACIN
(SUPPOSITORY)
(RECTAL) INDOMETHACIN
[GENERIC AB]
Drug
Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA
Applicant: ZYDUS NDA No.:
216184 Prod. No.:
001 RX (50MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Jan 30, 2024 |
Analgesics:Nonsteroidal Anti-inflammatory Drugs
LICART
(SYSTEM)
(TOPICAL) DICLOFENAC EPOLAMINE
Drug
Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
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 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
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
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
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
THALOMID
(CAPSULE) (ORAL)
THALIDOMIDE
Drug
Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA
Applicant: CELGENE NDA No.:
020785 Prod. No.:
001 RX (50MG); 002 RX (100MG); 003 RX
(200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 7230012
DP* Pharmaceutical compositions and dosage
forms of thalidomide Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Dec 9, 2023 |
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
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
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 [Has competitive generic]
Drug
Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA
Applicant: HORIZON NDA No.:
022511 Prod. No.:
001 DISC (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 [Has competitive generic]
Drug
Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA
Applicant: HORIZON NDA No.:
022511 Prod. No.:
002 DISC (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
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
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: 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
BRIXADI
(SOLUTION,
EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug
Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/
Substance Abuse Treatment Agents:Opioid Dependence
NDA
Applicant: BRAEBURN NDA No.:
210136 Prod. No.:
001 RX (8MG/0.16ML (50MG/ML)); 002 RX
(16MG/0.32ML (50MG/ML)); 003 RX (24MG/0.48ML
(50MG/ML)); 004 RX (32MG/0.64ML (50MG/ML)); 005 RX
(64MG/0.18ML (356MG/ML)); 006 RX (96MG/0.27ML
(356MG/ML)); 007 RX (128MG/0.36ML (356MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 8236292
DP* Liquid depot formulations Claim Types: Formulation; Method of administration; Process; Method of use Pat. Sub. Date(s): All strengths: Jun 6, 2023 |
Jan 10, 2027 | U-3619: A method of delivery of a bioactive agent by subcutaneous injection. a method of treatment of a human for addiction |
| Pat.
No. 8236755
DP* Opioid depot formulations Claim Types: Formulation; Method of administration; Process; Method of use Pat. Sub. Date(s): All strengths: Jun 6, 2023 |
Jul 31, 2026 | U-3620: A method of delivery of an opioid bioactive agent. a method of treatment or prophylaxis of a human or non-human animal for the treatment of opioid addiction and/or the symptoms of opioid withdrawal |
| Pat.
No. 8545832
DP* Lipid depot formulations Claim Types: Formulation; Method of administration; Process; Method of use Pat. Sub. Date(s): All strengths: Jun 6, 2023 |
Jun 6, 2025 | U-3619: A method of delivery of a bioactive agent by subcutaneous injection. a method of treatment of a human for addiction |
| Pat.
No. 9937164
DP* Opioid formulations Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: Jun 6, 2023 |
Jul 26, 2032 | U-3618: A method of sustained delivery of buprenorphine to a human or non-human animal body. a method for treatment for opioid maintenance therapy |
| Pat.
No. 10912772
Opioid formulations Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jun 6, 2023 |
Jul 26, 2032 | U-3617: A method of administering an opioid maintenance treatment comprising buprenorphine. a method of treating opioid withdrawal using an opioid maintenance treatment comprising buprenorphine |
| Pat.
No. 11110084
DP* Opioid formulations Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: Jun 6, 2023 |
Jul 26, 2032 | U-3616: A method of administering an opioid maintenance treatment comprising buprenorphine |
| Pat.
No. 11135215
DP* Opioid formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 6, 2023 |
Jul 26, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | May 23, 2026 |
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); 006 RX
(0.2MG/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): 001: Feb 5, 2018; 002: Feb 5, 2018; 003: Feb 5, 2018; 004: Feb 5, 2018; 005: Feb 5, 2018; 006: May 23, 2023 |
Mar 12, 2034 | |
| Pat.
No. 9731082
DP* Drug container Claim Types: Device; Process Pat. Sub. Date(s): 001: Feb 5, 2018; 002: Feb 5, 2018; 003: Feb 5, 2018; 004: Feb 5, 2018; 005: Feb 5, 2018; 006: May 23, 2023 |
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
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 treatment 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 treatment 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
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: OHEMO LIFE 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jul 3, 2026 |
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jul 3, 2026 |
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: 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 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 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 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 == 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
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
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); 006 RX
(0.2MG/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): 001: Feb 5, 2018; 002: Feb 5, 2018; 003: Feb 5, 2018; 004: Feb 5, 2018; 005: Feb 5, 2018; 006: May 23, 2023 |
Mar 12, 2034 | |
| Pat.
No. 9731082
DP* Drug container Claim Types: Device; Process Pat. Sub. Date(s): 001: Feb 5, 2018; 002: Feb 5, 2018; 003: Feb 5, 2018; 004: Feb 5, 2018; 005: Feb 5, 2018; 006: May 23, 2023 |
Apr 23, 2032 |
Analgesics:Opioid Analgesics, Short-acting
DYANAVEL XR
(SUSPENSION,
EXTENDED RELEASE) (ORAL) AMPHETAMINE; AMPHETAMINE
ASPARTATE/DEXTROAMPHETAMINE SULFATE
Drug
Classes: Analgesics:Opioid Analgesics, Short-acting
NDA
Applicant: TRIS PHARMA
INC NDA No.:
208147 Prod. No.:
001 RX (2MG/ML;EQ 0.5MG BASE/ML)
| 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: Oct 27, 2015 |
Mar 29, 2029 | |
| Pat.
No. 8597684
DP* Modified release formulations containing
drug-ion exchange resin complexes Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Oct 27, 2015 |
Mar 15, 2027 | |
| Pat.
No. 8747902
DP* Modified release formulations containing
drug-ion exchange resin complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 27, 2015 |
Mar 15, 2027 | |
| Pat.
No. 8883217
DP* Modified release formulations containing
drug-ion exchange resin complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 27, 2015 |
Mar 15, 2027 | |
| Pat.
No. 9675703
DP* Modified release formulations containing
drug - ion exchange resin complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 28, 2017 |
Mar 15, 2027 | |
| Pat.
No. 10086087
DP* Modified release formulations containing
drug-ion exchange resin complexes Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 3, 2018 |
Mar 15, 2027 | |
| Pat.
No. 11590228
DP* Extended Release amphetamine Compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 8, 2023 |
Sep 7, 2036 | U-3538: Method of treating attention deficit hyperactivity disorder |
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
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 treatment 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 treatment 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
MILPROSA
(SYSTEM)
(VAGINAL) PROGESTERONE
Drug
Classes: Analgesics:Opioid Analgesics, Short-acting
NDA
Applicant: FERRING PHARMS
INC NDA No.:
201110 Prod. No.:
001 DISC (1.78GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat.
No. 8580293
Monolithic intravaginal rings comprising progesterone
and methods of making and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2020 |
Jan 21, 2030 | U-2810: Method of supporting embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (ART) treatment program for infertile women |
| Pat.
No. 10537584
DP* Monolithic intravaginal rings comprising
progesterone and methods of making and uses thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 19, 2020 |
Feb 3, 2029 | |
| Pat.
No. 10548904
Monolithic intravaginal rings comprising progesterone
and methods of making and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2020 |
Feb 3, 2029 | U-2810: Method of supporting embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (ART) treatment program for infertile women |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Apr 29, 2023 |
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: OHEMO LIFE 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jul 3, 2026 |
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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jul 3, 2026 |
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
SMOFLIPID 20%
(EMULSION)
(INTRAVENOUS) FISH OIL; MEDIUM CHAIN TRIGLYCERIDES;
OLIVE OIL; SOYBEAN OIL
Drug
Classes: Analgesics:Opioid Analgesics, Short-acting
NDA
Applicant: FRESENIUS KABI
USA NDA No.:
207648 Prod. No.:
001 RX (3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML
(100ML)); 002 RX
(3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)); 003 RX
(3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)); 004 RX
(3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Mar 22, 2025 |
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 |