Orange Book Companion
Drug Classes starting with "ADEN" through "ANGI"

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


adenosine receptor agonist
LEXISCAN (SOLUTION) (INTRAVENOUS) REGADENOSON
Drug Classes: adenosine receptor agonist
NDA Applicant: ASTELLAS      NDA No.: 022161  Prod. No.: 001 RX (0.4MG/5ML (0.08MG/ML))
PatentsExpirationPatented Use
Pat. No. RE47301 DP* Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Claim Types: Product-by-process; Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Apr 2, 2019
Feb 2, 2027 
Pat. No. 6403567 DS* DP* [Extended 1024 days (2.8 years)]
N-pyrazole A2A adenosine receptor agonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: None
Apr 10, 2022U-869: Method for stimulating coronary vasodilation for purposes of imaging the heart
Pat. No. 8106183 DS* Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Mar 8, 2012
Feb 2, 2027 

adenosine triphosphate-citrate lyase (ACL) inhibitor
NEXLETOL (TABLET) (ORAL) BEMPEDOIC ACID
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == adenosine triphosphate-citrate lyase (ACL) inhibitor
NDA Applicant: ESPERION THERAPS INC      NDA No.: 211616  Prod. No.: 001 RX (180MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2023U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 21, 2025 

adenosine triphosphate-citrate lyase (ACL) inhibitor
NEXLIZET (TABLET) (ORAL) BEMPEDOIC ACID; EZETIMIBE
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other == adenosine triphosphate-citrate lyase (ACL) inhibitor == Cardiovascular Agents:Cardiovascular Combinations == dietary cholesterol absorption inhibitor
NDA Applicant: ESPERION THERAPS INC      NDA No.: 211617  Prod. No.: 001 RX (180MG;10MG)
PatentsExpirationPatented 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, 2023U-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, 2023U-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, 2023U-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, 2023U-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, 2036U-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, 2023U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 21, 2025 
Exclusivity Code: NP - New productFeb 26, 2023 

aldosterone antagonist
CAROSPIR (SUSPENSION) (ORAL) SPIRONOLACTONE
Drug Classes: Cardiovascular Agents:Diuretics, Potassium-sparing == Cardiovascular Agents:Cardiovascular Combinations == aldosterone antagonist
NDA Applicant: CMP DEV LLC      NDA No.: 209478  Prod. No.: 001 RX (25MG/5ML)
PatentsExpirationPatented Use
Pat. No. 9757394 DP* Spironolactone aqueous formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 21, 2017
Oct 28, 2036U-2109: CAROSPIR is indicated for treatment of NYHA class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure
Pat. No. 10493083 DP* Spironolactone aqueous compositions
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jan 2, 2020
Oct 28, 2036 
Pat. No. 10624906 DP* Spironolactone aqueous compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 27, 2020
Oct 28, 2036 
Pat. No. 10660907 DP* Spironolactone aqueous compositions
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jun 15, 2020
Oct 28, 2036 
Pat. No. 10888570 DP* Spironolactone aqueous compositions
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: Jan 15, 2021
Oct 28, 2036 

alkylating drug
BELRAPZO (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.: 205580  Prod. No.: 001 RX (100MG/4ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. 8609707 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 1, 2018
Aug 11, 2031U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 1, 2018
Jan 12, 2026U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9265831 DP* Formulations of bendamustine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 1, 2018
Jan 28, 2031 
Pat. No. 9572796 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 1, 2018
Jan 28, 2031U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9572797 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 1, 2018
Jan 28, 2031U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 10010533 DP* Formulations of bendamustine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 3, 2018
Jan 28, 2031 
Pat. No. 11103483 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2021
Jan 28, 2031U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma

alkylating drug
BENDEKA (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.: 208194  Prod. No.: 001 RX (100MG/4ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. 8609707 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 11, 2015
Aug 11, 2031U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 7, 2016
Jan 12, 2026U-1790: For use in treatment of patients with chronic lymphocytic leukemia (CLL) and/or non-hodgkin's lymphoma
Pat. No. 9000021 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 11, 2015
Mar 15, 2033U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 9034908 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 11, 2015
Mar 15, 2033U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 9144568 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 11, 2015
Mar 15, 2033U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 9265831 DP* Formulations of bendamustine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 1, 2016
Jan 28, 2031 
Pat. No. 9572796 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 21, 2017
Jan 28, 2031U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9572797 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2017
Jan 28, 2031U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9572887 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2017
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9579384 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 28, 2017
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9597397 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2017
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 9597398 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2017
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
Pat. No. 9597399 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2017
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 10010533 DP* Formulations of bendamustine
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 3, 2018
Jan 28, 2031 
Pat. No. 10052385 Formulations of bendamustine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2018
Mar 15, 2033U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
Pat. No. 11103483 DP* Formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 31, 2021
Jan 28, 2031U-1971: For the treatment of patients with chronic lymphocytic leukemia
U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 7, 2022ODE-179: Treatment of patients with CLL and treatment of patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen

alkylating drug
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ACROTECH      NDA No.: 207155  Prod. No.: 001 RX (EQ 50MG BASE/VIAL)
PatentsExpirationPatented 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, 2030U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityMar 10, 2023ODE-110: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma

alkylating drug
JELMYTO (POWDER) (PYELOCALYCEAL) MITOMYCIN
Drug Classes: alkylating drug
NDA Applicant: UROGEN PHARMA      NDA No.: 211728  Prod. No.: 001 RX (40MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 9040074 DP* Material and method for treating internal cavities
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Apr 29, 2020
Jan 20, 2031 
Pat. No. 9950069 DP* Material and method for treating internal cavities
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Apr 29, 2020
Jan 20, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productApr 15, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityApr 15, 2027ODE-289: Indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC)

alkylating drug
MITOSOL (FOR SOLUTION) (TOPICAL) MITOMYCIN
Drug Classes: alkylating drug
NDA Applicant: MOBIUS THERAP      NDA No.: 022572  Prod. No.: 001 RX (0.2MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7806265 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Drug in a container; Kit
Pat. Sub. Date(s): 001: Mar 22, 2012
Feb 1, 2029 
Pat. No. 8186511 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Drug in a container
Pat. Sub. Date(s): 001: Jun 25, 2012
Jul 19, 2026 
Pat. No. 9205075 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Kit
Pat. Sub. Date(s): 001: Jan 6, 2016
Jul 19, 2026 
Pat. No. 9539241 DS* DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 10, 2017
Jan 2, 2028U-2095: MITOSOL is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. It is intended for topical application to the site of glaucoma filtration surgery
Pat. No. 9649428 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Claim Types: Kit
Pat. Sub. Date(s): 001: Jun 9, 2017
May 21, 2029U-2095: MITOSOL is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. It is intended for topical application to the site of glaucoma filtration surgery

alkylating drug
PEPAXTO (POWDER) (INTRAVENOUS) MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ONCOPEPTIDES AB      NDA No.: 214383  Prod. No.: 001 RX (EQ 20MG BASE/VIAL)
PatentsExpirationPatented 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, 2022U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy
Pat. No. 10285946 DP* Lyophilized preparations of melphalan flufenamide
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: Mar 24, 2021
Apr 25, 2032 
Pat. No. 10322182 DP* Lyophilized preparation of cytotoxic dipeptides
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 24, 2021
Apr 25, 2032 
Pat. No. 10543274 Lyophilized preparation of cytotoxic dipeptides
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2021
Apr 25, 2032U-3093: In combination with dexamethasone to treat relapsed or refactory multiple myeloma (refactory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 anti-cd38 mab) in adults who received at least 4 prior lines of therapy
Pat. No. 10869928 DP* Lyophilized preparation of cytotoxic dipeptides
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 24, 2021
Apr 25, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFeb 26, 2026 
Exclusivity Code: ODE - Orphan drug exclusivityFeb 26, 2028ODE-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

alkylating drug
TEMODAR (POWDER) (INTRAVENOUS) TEMOZOLOMIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: MERCK SHARP DOHME      NDA No.: 022277  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 6987108 DP* Pharmaceutical formulations of antineoplastic agents and processes of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Sep 8, 2023 
Pat. No. 7786118 DP* Pharmaceutical formulations of antineoplastic agents
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Feb 21, 2023 
Pat. No. 8623868 DP* Processes of making and using pharmaceutical formulations of antineoplastic agents
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Jan 28, 2014
Feb 21, 2023 

alkylating drug
TEPADINA (POWDER) (INTRACAVITARY, INTRAVENOUS, INTRAVESICAL) THIOTEPA [GENERIC AP]
Drug Classes: alkylating drug
NDA Applicant: ADIENNE SA      NDA No.: 208264  Prod. No.: 001 RX (15MG/VIAL); 002 RX (100MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJan 26, 2024ODE-129: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan & cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor cell transplantation for peds. patients with class 3 beta-thalassemia

alkylating drug
TREANDA (POWDER) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: CEPHALON      NDA No.: 022249  Prod. No.: 001 RX (100MG/VIAL); 002 RX (25MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 8436190 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 4, 2013
Apr 26, 2031 *PED 
Pat. No. 8445524 DS* DP* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Jun 4, 2013
Sep 26, 2029 *PEDU-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL)
Pat. No. 8609863 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): All strengths: Jan 16, 2014
Jul 12, 2026 *PED 
Pat. No. 8669279 DP* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 30, 2014
Sep 26, 2029 *PEDU-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL)
Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 29, 2014
Jul 12, 2026 *PEDU-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma
Pat. No. 8883836 DP* Solid forms of bendamustine hydrochloride
Claim Types: Method of use; Product-by-process; Process
Pat. Sub. Date(s): All strengths: Nov 13, 2014
Sep 26, 2029 *PEDU-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL)
Pat. No. 8895756 DP* Bendamustine pharmaceutical compositions
Claim Types: Drug in a container
Pat. Sub. Date(s): All strengths: Nov 26, 2014
Jul 12, 2026 *PED 
Pat. No. 9533955 DP* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None; 002: Jan 13, 2017
Mar 26, 2029U-1949: For use in the treatment of patients with chronic lymphocytic leukemia (CLL)
U-1952: For use in the treatment of patients with indolent B-cell non-Hodgkin lymphoma

alkylating drug
TREANDA (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: CEPHALON      NDA No.: 022249  Prod. No.: 003 DISC (45MG/0.5ML (90MG/ML)); 004 DISC (180MG/2ML (90MG/ML))
PatentsExpirationPatented Use
Pat. No. 8344006 DP* Liquid formulations of bendamustine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Mar 23, 2030 *PEDU-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL)
Pat. No. 8445524 DS* Solid forms of bendamustine hydrochloride
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Sep 17, 2013
Sep 26, 2029 *PED 
Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 9, 2014
Jul 12, 2026 *PEDU-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma

alkylating drug
VALCHLOR (GEL) (TOPICAL) MECHLORETHAMINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: HELSINN      NDA No.: 202317  Prod. No.: 001 RX (EQ 0.016% BASE)
PatentsExpirationPatented Use
Pat. No. 7838564 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 7, 2026 
Pat. No. 7872050 Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Jul 8, 2029U-1427: Alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin directed therapy
Pat. No. 8450375 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 7, 2026 
Pat. No. 8501818 DP* Stabilized compositions of alkylating agents and methods of using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 7, 2026 
Pat. No. 8501819 Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 7, 2026U-1427: Alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin directed therapy
Pat. No. 9382191 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof
Claim Types: Composition
Pat. Sub. Date(s): 001: Jul 26, 2016
Mar 7, 2026 

alkylating drug
YONDELIS (POWDER) (INTRAVENOUS) TRABECTEDIN
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: JANSSEN PRODS      NDA No.: 207953  Prod. No.: 001 RX (1MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 8895557 DP* Pharmaceutical formulations of ecteinascidin compounds
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Nov 20, 2015
Jul 7, 2028 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDec 29, 2021 PEDM-232: Information added to section 8.4 of the labeling to describe the results from pediatric studies
Exclusivity Code: NCE - New chemical entityApr 23, 2021 PED 
Exclusivity Code: ODE - Orphan drug exclusivityApr 23, 2023 PEDODE-100: For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen

allylamine antifungal
NAFTIN (GEL) (TOPICAL) NAFTIFINE HYDROCHLORIDE
Drug Classes: Antifungals == allylamine antifungal
NDA Applicant: SEBELA IRELAND LTD      NDA No.: 204286  Prod. No.: 001 RX (2%)
PatentsExpirationPatented Use
Pat. No. 8778365 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 22, 2014
Jan 31, 2033 
Pat. No. 9161914 Topical compositions and methods for making and using same
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Nov 3, 2015
Jan 31, 2033U-540: Treatment of fungal infections
Pat. No. 10166205 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 19, 2019
Jan 31, 2033 
Pat. No. 10166206 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 19, 2019
Jan 31, 2033 
Pat. No. 10695303 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 27, 2020
Jan 31, 2033 
Pat. No. 10729667 DP* Topical compositions and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 31, 2020
Jan 31, 2033 

alpha adrenergic agonist
ADRENACLICK (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: IMPAX      NDA No.: 020800  Prod. No.: 003 RX (EQ 0.15MG/DELIVERY); 004 RX (EQ 0.3MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7905352 DP* Kits containing medicine injection devices and containers
Claim Types: Kit; Device
Pat. Sub. Date(s): All strengths: Jun 2, 2017
Apr 12, 2027 
Pat. No. 10166334 DP* Medicine injection apparatuses
Claim Types: Device
Pat. Sub. Date(s): All strengths: Feb 11, 2020
Jan 21, 2025 

alpha adrenergic agonist
ADRENALIN (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS      NDA No.: 204200  Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9119876 DP* Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 14, 2016
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Pat. Sub. Date(s): 001: Apr 12, 2016
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis

alpha adrenergic agonist
ADRENALIN (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE [GENERIC AP]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: PAR STERILE PRODUCTS      NDA No.: 204640  Prod. No.: 001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9119876 DP* Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 1, 2015
Mar 13, 2035 
Pat. No. 9295657 Epinephrine formulations
Claim Types: Method
Pat. Sub. Date(s): 001: Apr 12, 2016
Mar 13, 2035U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis
Pat. No. 10130592 DP* Epinephrine formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 26, 2018
Mar 13, 2035 

alpha adrenergic agonist
ADVIL ALLERGY SINUS (TABLET) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs == alpha adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021441  Prod. No.: 001 OTC (2MG;200MG;30MG)
PatentsExpirationPatented 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 

alpha adrenergic agonist
ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs == alpha adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021587  Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
PatentsExpirationPatented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 24, 2019
May 25, 2024 

alpha adrenergic agonist
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021262  Prod. No.: 001 RX (0.15%)
PatentsExpirationPatented Use
Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 10, 2022 *PED 
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 18, 2022 *PED 
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 28, 2022 *PED 
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 26, 2022 *PED 
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2016
Jan 10, 2022 *PEDU-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension

alpha adrenergic agonist
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: ALLERGAN      NDA No.: 021770  Prod. No.: 001 RX (0.1%)
PatentsExpirationPatented Use
Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 10, 2022 *PED 
Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 18, 2022 *PED 
Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 28, 2022 *PED 
Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 26, 2022 *PED 
Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 13, 2014
Mar 2, 2024 *PED 
Pat. No. 9295641 Compositions containing alpha-2-adrenergic agonist components
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2016
Jan 10, 2022 *PEDU-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 9687443 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 10, 2017
Jan 10, 2022 *PED 
Pat. No. 10307368 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 24, 2019
Jul 10, 2021 

alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Jun 1, 2026 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Jan 15, 2025 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Oct 30, 2028 
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 23, 2024 
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Mar 12, 2028 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Mar 21, 2025 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 26, 2013
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 21, 2013
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2012
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 21, 2012
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2012
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 23, 2013
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 15, 2014
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 29, 2015
Nov 23, 2024 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 5, 2015
Mar 31, 2026 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 16, 2015
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 6, 2015
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 18, 2016
Feb 20, 2027 
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 23, 2016
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 11, 2016
Feb 1, 2026 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 2, 2019
Apr 30, 2025 
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 25, 2020
Nov 23, 2024 
Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 22, 2021
Jun 25, 2026 

alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 002 RX (EQ 0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Jun 1, 2026 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Jan 15, 2025 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Oct 30, 2028 
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Mar 12, 2028 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Mar 21, 2025 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 26, 2013
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 15, 2014
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 29, 2015
Nov 23, 2024 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Feb 5, 2015
Mar 31, 2026 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 16, 2015
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Nov 6, 2015
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 002: Feb 18, 2016
Feb 20, 2027 
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 23, 2016
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Apr 11, 2016
Feb 1, 2026 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 2, 2019
Apr 30, 2025 
Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 25, 2020
Nov 23, 2024 
Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Apr 22, 2021
Jun 25, 2026 

alpha adrenergic agonist
AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Jun 1, 2026 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Jan 15, 2025 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Oct 30, 2028 
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 12, 2028 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 21, 2025 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 2, 2029 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 27, 2027 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Apr 10, 2029 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 25, 2028 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 31, 2026 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 20, 2027 
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 1, 2026 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9833573 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024U-2172: Method to treat severe allergic emergencies in patients weighing 7.5 to 15 kg (16.5 to 33 lbs)
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jul 2, 2019
Apr 30, 2025 
Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Aug 25, 2020
Nov 23, 2024 
Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 22, 2021
Jun 25, 2026 

alpha adrenergic agonist
CLARINEX D 24 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE [Has competitive generic]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == alpha adrenergic agonist
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021605  Prod. No.: 001 DISC (5MG;240MG)
PatentsExpirationPatented Use
Pat. No. 6979463 DP* Stable extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Mar 28, 2022 
Pat. No. 7618649 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jun 19, 2021 *PEDU-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis
Pat. No. 7820199 DP* Stable extended release oral dosage composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 23, 2010
Sep 28, 2022 *PED 

alpha adrenergic agonist
CLARINEX-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == alpha adrenergic agonist
NDA Applicant: ORGANON      NDA No.: 021313  Prod. No.: 001 RX (2.5MG;120MG)
PatentsExpirationPatented Use
Pat. No. 6709676 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Feb 18, 2021U-707: Allergic rhinitis
Pat. No. 7618649 DP* Extended release oral dosage composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jun 19, 2021 *PEDU-1017: A method of treating nasal and non-nasal symptoms of seasonal allergic rhinitis

alpha adrenergic agonist
COMBIGAN (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == Antimigraine Agents:Antimigraine Agents, Other == Cardiovascular Agents:Beta-adrenergic Blocking Agents == beta-adrenergic receptor inhibitor
NDA Applicant: ALLERGAN      NDA No.: 021398  Prod. No.: 001 RX (0.2%;EQ 0.5% BASE)
PatentsExpirationPatented Use
Pat. No. 7030149 Combination of brimonidine timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 19, 2022U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily
Pat. No. 7320976 Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 19, 2022U-849: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. dose is one drop of COMBIGAN in the affected eye twice daily
Pat. No. 7642258 DS* DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Kit
Pat. Sub. Date(s): 001: None
Apr 19, 2022U-1024: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP
Pat. No. 8133890 Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 2, 2012
Apr 19, 2022U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
Pat. No. 8354409 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Mar 27, 2013
Apr 19, 2022U-1371: Reduction of intraocular pressure in patients with elevated intraocular pressure or glaucoma
Pat. No. 8748425 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 7, 2014
Apr 19, 2022U-1524: Reduction of elevated intraocular pressure
Pat. No. 9474751 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 25, 2016
Apr 19, 2022U-1524: Reduction of elevated intraocular pressure
Pat. No. 9770453 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 12, 2017
Apr 19, 2022U-2131: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy, and a reduction in specified adverse events, compared to brimonidine 0.2% tid
Pat. No. 9907801 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 7, 2018
Apr 19, 2022U-2239: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with a reduction in specified adverse events, compared to brimonidine 0.2% tid
Pat. No. 9907802 DP* Combination of brimonidine and timolol for topical ophthalmic use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 7, 2018
Apr 19, 2022U-2240: Reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, with comparable efficacy to brimonidine 0.2% tid

alpha adrenergic agonist
EMERPHED (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: NEXUS PHARMS      NDA No.: 213407  Prod. No.: 001 RX (50MG/10ML (5MG/ML))
PatentsExpirationPatented Use
Pat. No. 11090278 Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Aug 13, 2021
May 16, 2040U-3183: Use of ephedrine sulfate for treating hypotension

alpha adrenergic agonist
EPHEDRINE SULFATE (SOLUTION) (INTRAVENOUS) EPHEDRINE SULFATE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == norepinephrine-releasing agent
NDA Applicant: ENDO VENTURES      NDA No.: 213994  Prod. No.: 001 RX (50MG/10ML (5MG/ML))
PatentsExpirationPatented Use
Pat. No. 10869845 DP* Ephedrine compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 22, 2020
Jan 22, 2040 

alpha adrenergic agonist
EPINEPHRINE (SOLUTION) (INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: BELCHER      NDA No.: 205029  Prod. No.: 001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
PatentsExpirationPatented Use
Pat. No. 9283197 DP* More potent and less toxic formulations of epinephrine and methods of medical use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 7, 2016
Aug 15, 2034U-1828: Increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock
U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis
U-1830: Induction and maintenance of mydriasis during intraocular surgery
Pat. No. 10004700 DP* More potent and less toxic formulations of epinephrine and methods of medical use
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jun 29, 2018
Aug 14, 2034U-2325: Emergency treatment of allergic reactions (Type 1), including anaphylaxis; a method of treating allergic reaction, anaphylaxis, anaphylactic shock, or combination thereof by an injection of at least one dosage of the injectable liquid pharmaceutical
Pat. No. 10039728 More potent and less toxic formulations of epinephrine and methods of medical use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 7, 2018
Aug 14, 2034U-1828: Increasing mean arterial blood pressure in adult patients with hypotension associated with septic shock

alpha adrenergic agonist
EPIPEN; EPIPEN JR. (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 019430  Prod. No.: 001 RX (0.3MG/DELIVERY); 002 RX (0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7449012 DP* Automatic injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Sep 11, 2025 
Pat. No. 7794432 DP* Automatic injector with kickback attenuation
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: None
Sep 11, 2025 
Pat. No. 8048035 DP* Automatic injector with needle cover
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 25, 2011; 002: None
Sep 11, 2025 
Pat. No. 8870827 DP* Automatic injector
Claim Types: Device
Pat. Sub. Date(s): All strengths: Oct 30, 2014
Sep 11, 2025 
Pat. No. 9586010 DP* Automatic injector with needle cover
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 12, 2017
Sep 11, 2025 

alpha adrenergic agonist
LIDOSITE TOPICAL SYSTEM KIT (PATCH) (IONTOPHORESIS, TOPICAL) EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine == Anesthetics:Local Anesthetics == amide local anesthetic == antiarrhythmic
NDA Applicant: VYTERIS      NDA No.: 021504  Prod. No.: 001 DISC (1.05MG/PATCH;100MG/PATCH)
PatentsExpirationPatented Use
Pat. No. 6635045 DS* DP* Electrodes and method for manufacturing electrodes for electrically assisted drug delivery
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Jun 29, 2021 

alpha adrenergic agonist
LUMIFY (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: BAUSCH AND LOMB INC      NDA No.: 208144  Prod. No.: 001 OTC (0.025%)
PatentsExpirationPatented Use
Pat. No. 8293742 Preferential vasoconstriction compositions and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 26, 2018
Jul 14, 2030U-2222: Relieves redness of the eye due to minor eye irritations
Pat. No. 9259425 Compositions and methods for eye whitening
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 27, 2021
Jul 14, 2030U-2222: Relieves redness of the eye due to minor eye irritations

alpha adrenergic agonist
MIRVASO (GEL) (TOPICAL) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: GALDERMA LABS LP      NDA No.: 204708  Prod. No.: 001 RX (EQ 0.33% BASE)
PatentsExpirationPatented Use
Pat. No. 7439241 Compounds, formulations, and methods for treating or preventing rosacea
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Aug 25, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8053427 DP* Brimonidine gel composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Jun 13, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8163725 DP* Gel compositions and methods of use
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Jun 13, 2031 
Pat. No. 8231885 DP* Compounds, formulations, and methods for ameliorating telangiectasis
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025 
Pat. No. 8410102 Methods and compositions for treating or preventing erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8426410 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8513247 DP* Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8513249 DP* Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8859551 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 27, 2014
May 25, 2024U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 9861631 Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 25, 2018
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 9861632 Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 25, 2018
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 10201517 DP* Brimonidine gel compositions and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 13, 2019
Jun 13, 2031 

alpha adrenergic agonist
PRIMATENE MIST (AEROSOL, METERED) (INHALATION) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARMSTRONG PHARMS      NDA No.: 205920  Prod. No.: 001 OTC (0.125MG/INH)
PatentsExpirationPatented Use
Pat. No. 8367734 DP* Stable epinephrine suspension formulation with high inhalation delivery efficiency
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 17, 2018
Jan 26, 2026 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productNov 7, 2021 

alpha adrenergic agonist
QOLIANA (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: SANDOZ INC      NDA No.: 021764  Prod. No.: 001 RX (0.15%)
PatentsExpirationPatented Use
Pat. No. 7265117 DP* Topical brimonidine tartrate formulations that lack chlorine dioxide
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Aug 19, 2025 

alpha adrenergic agonist
SIMBRINZA (SUSPENSION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; BRINZOLAMIDE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist == carbonic anhydrase inhibitor
NDA Applicant: ALCON LABS INC      NDA No.: 204251  Prod. No.: 001 RX (0.2%;1%)
PatentsExpirationPatented Use
Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 9, 2015
Oct 30, 2030 
Pat. No. 9421265 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2016
Jun 17, 2030 

alpha adrenergic agonist
TWINJECT 0.3; TWINJECT 0.15 (INJECTABLE) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: IMPAX      NDA No.: 020800  Prod. No.: 001 DISC (EQ 0.3MG/DELIVERY); 002 DISC (EQ 0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7297136 DP* Medicine injection devices and methods
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Jan 18, 2025 
Pat. No. 7621891 DP* Method and apparatus for delivering epinephrine
Claim Types: Device
Pat. Sub. Date(s): All strengths: None
Feb 4, 2025 

alpha adrenergic agonist
ZYRTEC-D 12 HOUR (TABLET, EXTENDED RELEASE) (ORAL) CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == alpha adrenergic agonist
NDA Applicant: J AND J CONSUMER INC      NDA No.: 021150  Prod. No.: 002 OTC (5MG;120MG)
PatentsExpirationPatented Use
Pat. No. 7014867 DP* Tablet comprising cetirizine and pseudoephedrine
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jun 10, 2022 
Pat. No. 7226614 Tablet comprising cetirizine and pseudoephedrine
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Jun 10, 2022U-295: Treatment of seasonal and perennial allergic rhinitis symptoms

alpha adrenergic blocker
COREG CR (CAPSULE, EXTENDED RELEASE) (ORAL) CARVEDILOL PHOSPHATE [GENERIC AB]
Drug Classes: Cardiovascular Agents:Beta-adrenergic Blocking Agents == alpha adrenergic blocker == beta-adrenergic receptor inhibitor
NDA Applicant: WOODWARD      NDA No.: 022012  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 7268156 DS* DP* Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): All strengths: None
Dec 27, 2023 *PEDU-313: Treatment of congestive heart failure
U-3: Treatment of hypertension
Pat. No. 8101209 DP* Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None
Mar 11, 2026 *PED 

alpha adrenergic blocker
ORAVERSE (INJECTABLE) (INJECTION) PHENTOLAMINE MESYLATE
Drug Classes: alpha adrenergic blocker
NDA Applicant: SEPTODONT HOLDING      NDA No.: 022159  Prod. No.: 001 RX (0.4MG/1.7ML)
PatentsExpirationPatented Use
Pat. No. 6764678 Local anesthetic methods and kits
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
May 11, 2021U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic
Pat. No. 6872390 DP* Local anesthetic methods and kits
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 11, 2021 
Pat. No. 7229630 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Claim Types: Formulation; Kit; Drug in a container
Pat. Sub. Date(s): 001: None
Jun 20, 2023 
Pat. No. 7569230 Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Oct 17, 2023U-967: A method of reversing soft-tissue anesthesia i.e. anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic
Pat. No. 7575757 DP* Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Claim Types: Formulation; Drug in a container
Pat. Sub. Date(s): 001: None
Apr 21, 2025 

alpha particle-emitting radioactive therapeutic agent
XOFIGO (SOLUTION) (INTRAVENOUS) RADIUM RA-223 DICHLORIDE
Drug Classes: alpha particle-emitting radioactive therapeutic agent
NDA Applicant: BAYER HLTHCARE      NDA No.: 203971  Prod. No.: 001 RX (162mCi/6ML (27mCi/ML))
PatentsExpirationPatented Use
Pat. No. 6635234 [Extended 1049 days (2.9 years)]
Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 11, 2013
Nov 17, 2022U-2271: Therapeutic treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease

alpha-1 adrenergic receptor agonist
OMIDRIA (SOLUTION) (IRRIGATION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor == Ophthalmic Agents:Ophthalmic Combinations == alpha-1 adrenergic receptor agonist
NDA Applicant: OMEROS      NDA No.: 205388  Prod. No.: 001 RX (EQ 0.3% BASE;EQ 1% BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJun 8, 2021 PED 

alpha-1 adrenergic receptor agonist
PHENYLEPHRINE HYDROCHLORIDE (SOLUTION/DROPS) (OPHTHALMIC) PHENYLEPHRINE HYDROCHLORIDE
Drug Classes: Ophthalmic Agents:Ophthalmic Combinations == alpha-1 adrenergic receptor agonist
NDA Applicant: PARAGON BIOTECK      NDA No.: 203510  Prod. No.: 001 RX (2.5%); 002 RX (10%)
PatentsExpirationPatented Use
Pat. No. 8859623 Methods and compositions of stable phenylephrine formulations
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 17, 2014
Nov 14, 2033U-1594: Dilation of the pupil

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

amide local anesthetic
EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.: 022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))
PatentsExpirationPatented Use
Pat. No. 9585838 DP* Production of multivesicular liposomes
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Apr 3, 2017
Dec 24, 2021 
Pat. No. 11033495 DP* Manufacturing of bupivacaine multivesicular liposomes
Claim Types: Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: Jul 30, 2021
Jan 22, 2041U-3182: Method of providing postsurgical pain management, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 6, 2021I-771: Revision of the indication section of the package insert regarding an interscalene brachial plexus nerve block to produce postsurgical regional analgesia
Exclusivity Code: NPP - New patient populationMar 22, 2024 

amide local anesthetic
LIDOSITE TOPICAL SYSTEM KIT (PATCH) (IONTOPHORESIS, TOPICAL) EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine == Anesthetics:Local Anesthetics == amide local anesthetic == antiarrhythmic
NDA Applicant: VYTERIS      NDA No.: 021504  Prod. No.: 001 DISC (1.05MG/PATCH;100MG/PATCH)
PatentsExpirationPatented Use
Pat. No. 6635045 DS* DP* Electrodes and method for manufacturing electrodes for electrically assisted drug delivery
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Jun 29, 2021 

amide local anesthetic
NAROPIN (SOLUTION) (INJECTION) ROPIVACAINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: amide local anesthetic
NDA Applicant: FRESENIUS KABI USA      NDA No.: 020533  Prod. No.: 006 RX (200MG/100ML (2MG/ML)); 007 RX (400MG/200ML (2MG/ML))
PatentsExpirationPatented Use
Pat. No. 7828787 DP* Connector for packaging containing medical fluids and packaging for medical fluids
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 6, 2014
Oct 18, 2025 
Pat. No. 7857802 DP* Connector for medical liquid-containing packages and medical liquid-containing packages
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 6, 2014
Nov 28, 2026 
Pat. No. 8118802 DP* Connector for packaging containing medical fluids and packaging for medical fluids
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 6, 2014
May 18, 2023 
Pat. No. 8162915 DP* Connector for packings containing medical liquids, and corresponding packing for medical liquids
Claim Types: Device
Pat. Sub. Date(s): All strengths: Nov 6, 2014
May 23, 2024 

amide local anesthetic
PLIAGLIS (CREAM) (TOPICAL) LIDOCAINE; TETRACAINE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == antiarrhythmic == ester local anesthetic
NDA Applicant: TARO PHARMS      NDA No.: 021717  Prod. No.: 001 RX (7%;7%)
PatentsExpirationPatented Use
Pat. No. 10350180 DP* Solid-forming local anesthetic formulations for pain control
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 4, 2019
Jan 14, 2031 
Pat. No. 10603293 DP* Solid-forming local anesthetic formulations for pain control
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 14, 2020
Jan 14, 2031 
Pat. No. 10751305 DP* Solid-forming topical formulations for pain control
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 21, 2020
Jan 14, 2031 

amide local anesthetic
POSIMIR (SOLUTION, EXTENDED RELEASE) (INFILTRATION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic
NDA Applicant: DURECT      NDA No.: 204803  Prod. No.: 001 DISC (660MG/5ML (132MG/ML))
PatentsExpirationPatented Use
Pat. No. 8153149 DP* Controlled delivery system
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 2, 2021
Sep 15, 2025 
Pat. No. 8153661 Controlled delivery system
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 2, 2021
Sep 15, 2025U-3074: Method for providing sustained local anesthesia for at least 24 hours
Pat. No. 8753665 DP* Controlled delivery system
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 2, 2021
Sep 15, 2025U-3074: Method for providing sustained local anesthesia for at least 24 hours
Pat. No. 8846072 DP* Controlled delivery system
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 2, 2021
Sep 15, 2025U-3074: Method for providing sustained local anesthesia for at least 24 hours
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 1, 2024 

amide local anesthetic
XARACOLL (IMPLANT) (IMPLANTATION) BUPIVACAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic
NDA Applicant: INNOCOLL PHARMS      NDA No.: 209511  Prod. No.: 001 RX (100MG)
PatentsExpirationPatented Use
Pat. No. RE47826 Drug delivery device for providing local analgesia, local anesthesia or nerve blockage
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 28, 2020
May 20, 2029U-2949: A method for inducing a post-surgical analgesia sparing effect by implanting at the surgical site a collagen sponge containing bupivacaine HCl which provides local anesthesia for up to 24 hours following implantation
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAug 28, 2023 

amide local anesthetic
ZINGO (SYSTEM) (INTRADERMAL) LIDOCAINE HYDROCHLORIDE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == antiarrhythmic
NDA Applicant: POWDER PHARMS      NDA No.: 022114  Prod. No.: 001 RX (0.5MG)
PatentsExpirationPatented Use
Pat. No. 8540665 Particle cassettes and processes therefor
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Oct 9, 2013
Oct 22, 2029U-1438: Zingo intradermal injection system is a drug delivery system that is capable of delivering fine dry powdered lidocaine hydrochloride monohydrate for local anesthetic action
Pat. No. 9358338 Particle cassettes and processes therefor
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Jul 6, 2016
Apr 27, 2035U-1870: ZINGO is a powder intradermal system that is capable of delivering fine dry powdered lidocaine hydrochloride monohydrate for local anesthetic action
Pat. No. 9370622 Devices and methods for delivering particles
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 6, 2016
Sep 28, 2035U-1870: ZINGO is a powder intradermal system that is capable of delivering fine dry powdered lidocaine hydrochloride monohydrate for local anesthetic action

amide local anesthetic
ZTLIDO (PATCH) (TOPICAL) LIDOCAINE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == antiarrhythmic
NDA Applicant: SCILEX PHARMS INC      NDA No.: 207962  Prod. No.: 001 RX (1.8%)
PatentsExpirationPatented Use
Pat. No. 9283174 DP* Non-aqueous patch
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 12, 2018
May 10, 2031 
Pat. No. 9925264 DP* Non-aqueous patch
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 25, 2018
May 10, 2031U-2267: Method for relieving the pain associated with post-herpetic neuralgia
Pat. No. 9931403 DP* Non-aqueous patch
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 25, 2018
May 10, 2031 
Pat. No. 10765640 DP* Non-aqueous patch
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
May 10, 2031 
Pat. No. 10765749 DP* Non-aqueous patch
Claim Types: Device
Pat. Sub. Date(s): 001: Oct 6, 2020
May 10, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 28, 2021 

amide local anesthetic
ZYNRELEF KIT (SOLUTION, EXTENDED RELEASE) (PERIARTICULAR) BUPIVACAINE; MELOXICAM
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HERON THERAPS INC      NDA No.: 211988  Prod. No.: 001 RX (60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)); 002 RX (200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)); 003 RX (300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)); 004 RX (400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML))
PatentsExpirationPatented 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, 2034U-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, 2035U-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, 2035U-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, 2034U-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, 2035U-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, 2035U-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, 2035U-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, 2035U-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, 2035U-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, 2035U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 12, 2024 

aminoglycoside antibacterial
ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: Antibacterials:Aminoglycosides == aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.: 207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
PatentsExpirationPatented Use
Pat. No. 7718189 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jun 6, 2025U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8226975 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Aug 15, 2028 
Pat. No. 8632804 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen
Pat. No. 8642075 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026 
Pat. No. 8679532 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8802137 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 9566234 DP* Systems for treating pulmonary infections
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jan 18, 2034U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9827317 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9895385 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
May 15, 2035U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen
Pat. No. 10251900 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2019
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 10751355 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 24, 2020
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
ExclusivityExpirationExclusivity Description
Exclusivity Code: GAIN - Generating Antibiotic Incentives NowSep 28, 2030 
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2025ODE-214: Tx of MAC lung disease in adults with limited or no alternative tx options as part of a combo antibacterial drug regimen who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

aminoglycoside antibacterial
BETHKIS (SOLUTION) (INHALATION) TOBRAMYCIN [GENERIC AN]
Drug Classes: Antibacterials:Aminoglycosides == Ophthalmic Agents:Ophthalmic Anti-Infectives == Ophthalmic Agents:Ophthalmic Combinations == Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == aminoglycoside antibacterial
NDA Applicant: CHIESI      NDA No.: 201820  Prod. No.: 001 RX (300MG/4ML)
PatentsExpirationPatented Use
Pat. No. 6987094 DP* Optimized formulation of tobramycin for aerosolization
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 30, 2013
Sep 22, 2022 
Pat. No. 7696178 DP* Optimised formulation of tobramycin for aerosolization
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jan 30, 2013
Sep 22, 2022 
Pat. No. 7939502 Optimised formulation of tobramycin for aerosolization
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 30, 2013
Jun 14, 2022U-1324: Management of cystic fibrosis patients

aminoglycoside antibacterial
TOBI PODHALER (POWDER) (INHALATION) TOBRAMYCIN
Drug Classes: Antibacterials:Aminoglycosides == Ophthalmic Agents:Ophthalmic Anti-Infectives == Ophthalmic Agents:Ophthalmic Combinations == Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == aminoglycoside antibacterial
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 201688  Prod. No.: 001 RX (28MG)
PatentsExpirationPatented Use
Pat. No. RE47526 DP* Aerosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 1, 2020
Apr 9, 2024 
Pat. No. 7368102 DP* Pulmonary delivery of aminoglycosides
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Apr 19, 2013
Dec 19, 2022U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 7516741 DP* Aerosolization apparatus with feedback mechanism
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Apr 19, 2013
Jan 11, 2024 
Pat. No. 7559325 DP* Aerosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 19, 2013
Oct 27, 2025 
Pat. No. 8069851 DP* Aeorosolization apparatus with air inlet shield
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 19, 2013
Sep 24, 2024 
Pat. No. 8664187 Methods of treatment of endobronchial infections
Claim Types: Method of improving a treatment; Method of use
Pat. Sub. Date(s): 001: Jun 17, 2019
Jun 20, 2025U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 8715623 DP* Pulmonary delivery of aminoglycoside
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: Oct 20, 2014
Dec 19, 2022U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 8869794 DP* Aerosolization apparatus with capsule puncturing member
Claim Types: Device; Process; Part of a dosage form; Method of administration
Pat. Sub. Date(s): 001: Jun 17, 2019
Sep 12, 2028U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 9421166 DP* Pulmonary delivery of aminoglycoside
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Jun 17, 2019
Dec 19, 2022U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa
Pat. No. 10207066 DP* Aerosolization apparatus with capsule puncture alignment guide
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jun 17, 2019
Nov 4, 2030U-909: Treatment of cystic fibrosis patients with pseudomonas aeruginosa

aminoglycoside antibacterial
TOBRADEX ST (SUSPENSION/DROPS) (OPHTHALMIC) DEXAMETHASONE; TOBRAMYCIN
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid == Antibacterials:Aminoglycosides == Ophthalmic Agents:Ophthalmic Anti-Infectives == Ophthalmic Agents:Ophthalmic Combinations == Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == aminoglycoside antibacterial
NDA Applicant: EYEVANCE      NDA No.: 050818  Prod. No.: 001 RX (0.05%;0.3%)
PatentsExpirationPatented Use
Pat. No. 7795316 DP* Topical ophthalmic compositions containing tobramycin and dexamethasone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 30, 2010
Aug 3, 2028U-1082: Use of a combination of tobramycin and dexamethasone to treat ocular inflammation where an infection or risk of infection exists
Pat. No. 8101582 DP* Topical ophthalmic compositions containing tobramycin and dexamethasone
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 27, 2012
Dec 19, 2027U-1082: Use of a combination of tobramycin and dexamethasone to treat ocular inflammation where an infection or risk of infection exists
Pat. No. 8450287 DP* Topical ophthalmic compositions containing tobramycin and dexamethasone
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 16, 2016
Dec 19, 2027 

aminoketone
APLENZIN (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROBROMIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone
NDA Applicant: BAUSCH      NDA No.: 022108  Prod. No.: 001 RX (174MG); 002 RX (348MG); 003 RX (522MG)
PatentsExpirationPatented Use
Pat. No. 7241805 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7569610 Modified release formulations of a bupropion salt
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026U-997: Treatment of major depressive disorder by dosing at intervals of 24 hours
Pat. No. 7572935 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7585897 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7645802 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7649019 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7662407 DP* Modified release formulations of a bupropion salt
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 
Pat. No. 7671094 DP* Bupropion hydrobromide and therapeutic applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Jun 27, 2026 

aminoketone
CONTRAVE (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone == Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist
NDA Applicant: NALPROPION      NDA No.: 200063  Prod. No.: 001 RX (90MG;8MG)
PatentsExpirationPatented Use
Pat. No. 7375111 DP* Compositions for affecting weight loss
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2014
Mar 26, 2025 
Pat. No. 7462626 Compositions for affecting weight loss
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Jul 20, 2024U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 8088786 DP* Layered pharmaceutical formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2014
Feb 3, 2029 
Pat. No. 8318788 Layered pharmaceutical formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Nov 8, 2027U-1584: Use of naltrexone and bupropion in a layered formulation for chronic weight management for affecting weight loss
Pat. No. 8722085 Methods for administering weight loss medications
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 8815889 Compositions and methods for increasing insulin sensitivity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Jul 20, 2024U-1586: For effect on blood glucose parameters in patients with insulin resistance
Pat. No. 8916195 Sustained release formulation of naltrexone
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 20, 2015
Feb 2, 2030U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity
Pat. No. 9107837 Sustained release formulation of naltrexone
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 3, 2015
Jun 4, 2027U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity
Pat. No. 9125868 Methods for administering weight loss medications
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 15, 2015
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 9248123 Methods of providing weight loss therapy in patients with major depression
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 17, 2016
Jan 13, 2032U-1808: Use of naltrexone and bupropion for chronic weight management for treating overweight or obesity in patients with major depressive disorder
Pat. No. 9633575 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 25, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10231964 Compositions and methods for weight loss in at risk patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2019
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10307376 Methods for administering weight loss medications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 17, 2019
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 10403170 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 5, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10828294 Compositions and methods for weight loss in at risk patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 14, 2020
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10835527 Compositions and methods for reducing major adverse cardiovascular events
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 14, 2020
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 11033543 Methods of providing weight loss therapy in patients with major depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 22, 2021
Jan 10, 2031U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 11139056 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 5, 2033U-1583: For chronic weight management for treating overweight or obesity

aminoketone
FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone
NDA Applicant: ALMATICA      NDA No.: 022497  Prod. No.: 001 RX (450MG)
PatentsExpirationPatented Use
Pat. No. 7674479 DP* Sustained-release bupropion and bupropion/mecamylamine tablets
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 28, 2011
Jun 25, 2027 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN      NDA No.: 021528  Prod. No.: 001 RX (0.4%)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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, 2024U-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, 2024U-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, 2024U-1800: A method of treating ocular pain and/or enhancing ocular comfort

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN      NDA No.: 022427  Prod. No.: 001 RX (0.45%)
PatentsExpirationPatented 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: histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs == alpha adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021441  Prod. No.: 001 OTC (2MG;200MG;30MG)
PatentsExpirationPatented 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: histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs == alpha adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021587  Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
PatentsExpirationPatented 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
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 211733  Prod. No.: 001 OTC (250MG;125MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 28, 2023 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL PM (CAPSULE) (ORAL) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN [GENERIC OTC]
Drug Classes: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021393  Prod. No.: 001 OTC (25MG;EQ 200MG FREE ACID AND POTASSIUM SALT)
PatentsExpirationPatented Use
Pat. No. 8883849 Treatment of sleep disturbances
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2014
Jan 17, 2022U-1618: A method of treating a patient suffering from a pain associated sleep disturbance comprising administering a liquid composition formulated inside a soft gel capsule, as claimed, to the patient
Pat. No. 9155718 DP* Treatment of sleep disturbances
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 10, 2015
Jan 17, 2022 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ADVIL PM (TABLET) (ORAL) DIPHENHYDRAMINE CITRATE; IBUPROFEN [GENERIC OTC]
Drug Classes: Antiemetics:Antiemetics, Other == Antiparkinson Agents:Anticholinergics == Respiratory Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021394  Prod. No.: 001 OTC (38MG;200MG)
PatentsExpirationPatented Use
Pat. No. 8263647 DP* Treatment of sleep disturbances
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
May 30, 2022 

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)
PatentsExpirationPatented 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 RX (30MG/ML (30MG/ML))
PatentsExpirationPatented Use
Pat. No. 8512727 DP* Nanoparticulate meloxicam formulations
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: Mar 6, 2020
Dec 25, 2022U-2750: Management of moderate-to-severe pain by intravenous injection
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, 2024U-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, 2024U-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, 2030U-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, 2039U-3038: Management of moderate-to-severe pain by intravenous injection in patients with mild renal impairment
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFeb 20, 2023 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
CALDOLOR (SOLUTION) (INTRAVENOUS) IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 022348  Prod. No.: 001 DISC (400MG/4ML (100MG/ML))
PatentsExpirationPatented Use
Pat. No. 6727286 DP* Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 001: None
Nov 27, 2021U-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

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))
PatentsExpirationPatented Use
Pat. No. 6727286 DP* Pharmaceutical composition of 2-(4-isobutylphenyl) propionic acid
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): 002: None
Nov 27, 2021U-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. 8735452 Treating patients with intravenous ibuprofen
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Jun 4, 2014
Sep 30, 2029U-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, 2029U-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, 2030U-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, 2029U-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, 2029U-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, 2029U-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, 2029U-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

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))
PatentsExpirationPatented 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, 2029U-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, 2029U-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, 2030U-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, 2032U-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, 2032U-2266: Methods of making aqueous composition and treating pain, inflammation, fever, patent ductus arteriosis with aqueous composition

Analgesics:Nonsteroidal Anti-inflammatory Drugs
CAMBIA (FOR SOLUTION) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ASSERTIO      NDA No.: 022165  Prod. No.: 001 RX (50MG)
PatentsExpirationPatented 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, 2026U-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, 2026U-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, 2026U-436: Acute treatment of migraine attacks with or without aura in adults
Pat. No. 9827197 DP* Diclofenac formulations and methods of use
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Dec 5, 2017
Jun 16, 2026 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
CONSENSI (TABLET) (ORAL) AMLODIPINE BESYLATE; CELECOXIB
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == dihydropyridine calcium channel blocker == 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)
PatentsExpirationPatented 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, 2030U-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, 2029U-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, 2038U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationMay 31, 2021 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
DUEXIS (TABLET) (ORAL) FAMOTIDINE; IBUPROFEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON      NDA No.: 022519  Prod. No.: 001 RX (26.6MG;800MG)
PatentsExpirationPatented Use
Pat. No. 8067033 DP* Stable compositions of famotidine and ibuprofen
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 30, 2011
Jul 18, 2026 
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, 2026U-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, 2026U-1196: Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications

Analgesics:Nonsteroidal Anti-inflammatory Drugs
DYLOJECT (SOLUTION) (INTRAVENOUS) DICLOFENAC SODIUM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: JAVELIN PHARMS INC      NDA No.: 022396  Prod. No.: 001 DISC (37.5MG/ML (37.5MG/ML)**)
PatentsExpirationPatented 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, 2027U-1659: Management of pain

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ELYXYB (SOLUTION) (ORAL) CELECOXIB
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BDSI      NDA No.: 212157  Prod. No.: 001 DISC (25MG/ML)
PatentsExpirationPatented 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, 2036U-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, 2036U-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, 2036U-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, 2036U-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, 2036U-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, 2036U-2718: Acute treatment of migraine with or without aura in adults
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 5, 2023 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
LICART (SYSTEM) (TOPICAL) DICLOFENAC EPOLAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: IBSA INST BIO      NDA No.: 206976  Prod. No.: 001 RX (1.3%)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productDec 19, 2021 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
NAPROXEN SODIUM (CAPSULE) (ORAL) NAPROXEN SODIUM [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: BIONPHARMA INC      NDA No.: 021920  Prod. No.: 001 OTC (EQ 200MG BASE)
PatentsExpirationPatented 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, 2026U-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, 2026U-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, 2026U-1731: Temporary relief of minor aches and pains
U-1732: Temporary reduction of fever
U-3195: U-1731 U-1732

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

Analgesics:Nonsteroidal Anti-inflammatory Drugs
OMIDRIA (SOLUTION) (IRRIGATION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor == Ophthalmic Agents:Ophthalmic Combinations == alpha-1 adrenergic receptor agonist
NDA Applicant: OMEROS      NDA No.: 205388  Prod. No.: 001 RX (EQ 0.3% BASE;EQ 1% BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJun 8, 2021 PED 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
PENNSAID (SOLUTION) (TOPICAL) DICLOFENAC SODIUM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: NUVO PHARMS INC      NDA No.: 020947  Prod. No.: 001 DISC (1.5%**)
PatentsExpirationPatented 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, 2029U-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, 2030U-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, 2029U-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, 2029U-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
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: HORIZON      NDA No.: 204623  Prod. No.: 001 RX (2%)
PatentsExpirationPatented 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, 2029U-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, 2028U-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, 2030U-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, 2027U-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, 2029U-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, 2029U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2029U-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, 2029U-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, 2029U-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, 2027U-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)
PatentsExpirationPatented 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
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)
PatentsExpirationPatented 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, 2030U-55: Treatment of pain

Analgesics:Nonsteroidal Anti-inflammatory Drugs
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Antimigraine Agents:Serotonin (5-HT) Receptor Agonists == serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX      NDA No.: 021926  Prod. No.: 001 RX (500MG;EQ 85MG BASE)
PatentsExpirationPatented 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 *PEDU-867: Treatment of migraine

Analgesics:Nonsteroidal Anti-inflammatory Drugs
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Antimigraine Agents:Serotonin (5-HT) Receptor Agonists == serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX      NDA No.: 021926  Prod. No.: 002 DISC (60MG;EQ 10MG BASE)
PatentsExpirationPatented 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 *PEDU-1719: Acute treatment of migraine

Analgesics:Nonsteroidal Anti-inflammatory Drugs
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON      NDA No.: 022511  Prod. No.: 001 RX (EQ 20MG BASE;500MG)
PatentsExpirationPatented Use
Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Feb 28, 2023U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 29, 2013
May 31, 2022 
Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 29, 2014
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 29, 2014
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
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, 2031U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin
Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 12, 2015
May 31, 2022U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment
Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 17, 2015
May 31, 2022U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
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, 2031U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 23, 2016
May 31, 2022 
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, 2029U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 17, 2017
May 31, 2022 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
VIMOVO (TABLET, DELAYED RELEASE) (ORAL) ESOMEPRAZOLE MAGNESIUM; NAPROXEN [GENERIC AB]
Drug Classes: Gastrointestinal Agents:Proton Pump Inhibitors == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HORIZON      NDA No.: 022511  Prod. No.: 002 RX (EQ 20MG BASE;375MG)
PatentsExpirationPatented Use
Pat. No. 6926907 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: None
Feb 28, 2023U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 8557285 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 002: Oct 29, 2013
May 31, 2022 
Pat. No. 8852636 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 29, 2014
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
Pat. No. 8858996 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDS
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 29, 2014
May 31, 2022U-1052: Relief of signs and symptoms of arthritis and risk-reduction of NSAID-associated gastric ulcer
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, 2031U-1661: Risk-reduction of NSAID-associated gastric ulcers in patients also taking low dose aspirin
Pat. No. 9161920 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 12, 2015
May 31, 2022U-1760: Risk-reduction of nsaid gastric ulcer in patients requiring chronic nsaid treatment
Pat. No. 9198888 Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Dec 17, 2015
May 31, 2022U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9345695 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 23, 2016
May 31, 2022 
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, 2029U-1781: Risk-reduction of NSAID-associated gastric ulcer in patients requiring NSAID treatment
Pat. No. 9707181 DP* Pharmaceutical compositions for the coordinated delivery of NSAIDs
Claim Types: Formulation
Pat. Sub. Date(s): 002: Aug 17, 2017
May 31, 2022 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
VIVLODEX (CAPSULE) (ORAL) MELOXICAM
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: ZYLA      NDA No.: 207233  Prod. No.: 001 DISC (5MG**); 002 DISC (10MG**)
PatentsExpirationPatented 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, 2035U-2160: Management of osteoarthritis pain by administering 5 mg of meloxicam
U-2165: Management of osteoarthritis pain by administering 10 mg of meloxicam

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ZIPSOR (CAPSULE) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ASSERTIO      NDA No.: 022202  Prod. No.: 001 RX (25MG)
PatentsExpirationPatented Use
Pat. No. 7662858 Method of treating post-surgical acute pain
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Feb 24, 2029U-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, 2029U-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, 2029U-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, 2029U-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, 2029U-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, 2029U-1482: Diclofenac potassium for relief of mild to moderate acute pain
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationMay 25, 2024 

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ZORVOLEX (CAPSULE) (ORAL) DICLOFENAC
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ZYLA      NDA No.: 204592  Prod. No.: 002 RX (35MG) NDA No.: 204592  Prod. No.: 001 DISC (18MG)
PatentsExpirationPatented 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, 2030U-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, 2030U-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, 2030U-55: Treatment of pain

Analgesics:Nonsteroidal Anti-inflammatory Drugs
ZYNRELEF KIT (SOLUTION, EXTENDED RELEASE) (PERIARTICULAR) BUPIVACAINE; MELOXICAM
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic == Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: HERON THERAPS INC      NDA No.: 211988  Prod. No.: 001 RX (60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)); 002 RX (200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)); 003 RX (300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)); 004 RX (400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML))
PatentsExpirationPatented 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, 2034U-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, 2035U-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, 2035U-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, 2034U-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, 2035U-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, 2035U-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, 2035U-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, 2035U-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, 2035U-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, 2035U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMay 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 == opioid agonist
NDA Applicant: ZYLA      NDA No.: 208603  Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG)
PatentsExpirationPatented 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, 2033U-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, 2033U-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 [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist
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)
PatentsExpirationPatented 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, 2027U-1769: Treatement [sic, Treatment] of pain by transmucosal delivery of buprenorphine
Pat. No. 9655843 DP* Transmucosal delivery devices with enhanced uptake
Claim Types: Method of administration; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 13, 2017
Jul 23, 2027U-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, 2032U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Analgesics:Opioid Analgesics, Long-acting
BUNAVAIL (FILM) (BUCCAL) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
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)
PatentsExpirationPatented 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, 2027U-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, 2027U-2017: Treatment of opioid dependence

Analgesics:Opioid Analgesics, Long-acting
CONZIP (CAPSULE, EXTENDED RELEASE) (ORAL) TRAMADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: CIPHER PHARMS INC      NDA No.: 022370  Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 7858118 DP* Extended release composition containing Tramadol
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Apr 11, 2022U-1104: Use of tramadol for the management of moderate to moderately severe chronic pain

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 == opioid agonist
NDA Applicant: FRESENIUS KABI USA      NDA No.: 019034  Prod. No.: 003 RX (1MG/ML); 004 RX (2MG/ML) NDA No.: 019034  Prod. No.: 001 DISC (10MG/ML); 002 DISC (250MG/VIAL); 005 DISC (4MG/ML)
PatentsExpirationPatented Use
Pat. No. 9248229 DP* Packaging system for oxygen-sensitive drugs
Claim Types: Drug in a container
Pat. Sub. Date(s): All strengths: Feb 5, 2018
Mar 12, 2034 
Pat. No. 9731082 DP* Drug container
Claim Types: Device; Process
Pat. Sub. Date(s): All strengths: Feb 5, 2018
Apr 23, 2032 

Analgesics:Opioid Analgesics, Long-acting
EMBEDA (CAPSULE, EXTENDED RELEASE) (ORAL) MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist
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)
PatentsExpirationPatented Use
Pat. No. 7682633 Pharmaceutical composition
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jun 19, 2027U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed.
Pat. No. 7682634 DP* Pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Jun 19, 2027 
Pat. No. 7815934 DP* Sequestering subunit and related compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 19, 2010; 002: None; 003: None; 004: None; 005: None; 006: None
Dec 12, 2027 
Pat. No. 8158156 Abuse-deterrent multi-layer pharmaceutical composition comprising an opioid antagonist and an opioid agonist
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: None; 004: None; 005: None; 006: None
Jun 19, 2027U-1510: Management of pain severe enough to require daily, around-the-clock, long term opioid treatement by orally administering an intact composition as claimed.
Pat. No. 8623418 Pharmaceutical composition
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Jan 22, 2015
Nov 7, 2029U-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, 2025U-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 == opioid agonist
NDA Applicant: CEPHALON      NDA No.: 021947  Prod. No.: 001 RX (EQ 0.1MG BASE)
PatentsExpirationPatented 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 == opioid agonist
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)
PatentsExpirationPatented Use
Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011
Jun 15, 2028 
Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates
Claim Types: Formulation
Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011
Jun 15, 2028 
Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Dec 30, 2024 
Pat. No. 8119158 DP* Effervescent oral fentanyl dosage form and methods of administering fentanyl
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 002: Feb 23, 2012; 003: None; 004: None; 005: None
Dec 30, 2024 

Analgesics:Opioid Analgesics, Long-acting
HYSINGLA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough == opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 206627  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG); 004 RX (60MG); 005 RX (80MG); 006 RX (100MG); 007 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 6733783 DP* Controlled release hydrocodone formulations
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Nov 21, 2014
Oct 30, 2021U-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. 8309060 DP* Abuse-proofed dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 21, 2014
Nov 20, 2023U-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. 8361499 DP* Controlled release hydrocodone formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 21, 2014
Oct 30, 2021 
Pat. No. 8529948 DP* Pharmaceutical formulation containing gelling agent
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 21, 2014
Aug 6, 2022 
Pat. No. 8551520 DP* Controlled release hydrocodone
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 21, 2014
Oct 30, 2021 
Pat. No. 8647667 DP* Controlled release hydrocodone formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 21, 2014
Oct 30, 2021 
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, 2031U-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, 2027U-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, 2027U-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, 2027U-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, 2027U-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, 2023U-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 

Analgesics:Opioid Analgesics, Long-acting
IONSYS (SYSTEM) (IONTOPHORESIS, TRANSDERMAL) FENTANYL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: THE MEDICINES CO      NDA No.: 021338  Prod. No.: 001 DISC (EQ 40MCG BASE/ACTIVATION)
PatentsExpirationPatented Use
Pat. No. 6881208 Method and device for transdermal electrotransport delivery of fentanyl and sufentanil
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 19, 2022U-736: Method for iontophoretic transdermal delivery of fentanyl hydrochloride
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, 2032U-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, 2032U-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, 2032U-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, 2031U-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 == opioid agonist
NDA Applicant: BTCP PHARMA      NDA No.: 022569  Prod. No.: 001 RX (EQ 0.1MG BASE); 002 RX (EQ 0.4MG BASE)
PatentsExpirationPatented 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, 2024U-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, 2024U-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 == opioid agonist
NDA Applicant: BTCP PHARMA      NDA No.: 022569  Prod. No.: 003 DISC (EQ 0.3MG BASE)
PatentsExpirationPatented 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 == opioid agonist
NDA Applicant: DAIICHI SANKYO INC      NDA No.: 206544  Prod. No.: 001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG); 004 DISC (100MG)
PatentsExpirationPatented 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 == opioid agonist
NDA Applicant: HIKMA PHARMS      NDA No.: 022195  Prod. No.: 001 RX (10MG/5ML); 002 RX (20MG/5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJun 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 == opioid agonist
NDA Applicant: HIKMA      NDA No.: 022207  Prod. No.: 001 RX (15MG); 002 RX (30MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJun 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 == opioid agonist
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))
PatentsExpirationPatented 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, 2034U-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
MORPHINE SULFATE (TABLET) (ORAL) MORPHINE SULFATE [GENERIC AB]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ALKEM LABS LTD      NDA No.: 212451  Prod. No.: 001 RX (15MG); 002 RX (30MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: CGT - Competitive generic therapyAug 10, 2021 

Analgesics:Opioid Analgesics, Long-acting
NUCYNTA (TABLET) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
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)
PatentsExpirationPatented Use
Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)]
1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jul 21, 2011
Aug 5, 2022U-931: Relief of moderate to severe acute pain
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, 2025U-931: Relief of moderate to severe acute pain

Analgesics:Opioid Analgesics, Long-acting
NUCYNTA (SOLUTION) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: COLLEGIUM PHARM INC      NDA No.: 203794  Prod. No.: 001 DISC (EQ 20MG BASE/ML)
PatentsExpirationPatented Use
Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)]
1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Aug 5, 2022U-1289: Management of moderate to severe acute pain
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, 2025U-1289: Management of moderate to severe acute pain

Analgesics:Opioid Analgesics, Long-acting
NUCYNTA ER (TABLET, EXTENDED RELEASE) (ORAL) TAPENTADOL HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
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)
PatentsExpirationPatented Use
Pat. No. RE39593 DS* DP* [Extended 1508 days (4.1 years)]
1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2011; 002: None; 003: None; 004: None; 005: None
Aug 5, 2022U-1178: Relief of moderate to severe chronic pain
U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
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, 2025U-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, 2023U-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, 2028U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy
Pat. No. 11007156 DP* Prolonged release pharmaceutical composition containing 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 17, 2021
Oct 22, 2022U-1178: Relief of moderate to severe chronic pain
U-1276: Management of neuropathic pain associated with diabetic peripheral neuropathy

Analgesics:Opioid Analgesics, Long-acting
OBREDON (SOLUTION) (ORAL) GUAIFENESIN; HYDROCODONE BITARTRATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cold-Cough == Analgesics:Opioid Analgesics, Long-acting == opioid agonist
NDA Applicant: SOVEREIGN PHARMS      NDA No.: 205474  Prod. No.: 001 DISC (200MG/5ML;2.5MG/5ML)
PatentsExpirationPatented 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, 2035U-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, 2035U-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, 2035U-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 == opioid agonist
NDA Applicant: BDSI      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)
PatentsExpirationPatented 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, 2027U-767: Management of breakthrough pain in patients with cancer

Analgesics:Opioid Analgesics, Long-acting
OPANA (TABLET) (ORAL) OXYMORPHONE HYDROCHLORIDE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: ENDO PHARMS      NDA No.: 021611  Prod. No.: 001 DISC (5MG); 002 DISC (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousOct 25, 2022M-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 == opioid agonist
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**)
PatentsExpirationPatented 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, 2023U-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, 2027U-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 == opioid agonist
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)
PatentsExpirationPatented 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, 2027U-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 == opioid agonist
NDA Applicant: ZYLA      NDA No.: 202080  Prod. No.: 001 RX (5MG); 002 RX (7.5MG)
PatentsExpirationPatented 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 == opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 022272  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG)
PatentsExpirationPatented 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, 2023U-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, 2027U-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, 2027U-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, 2027U-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, 2023U-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 

Analgesics:Opioid Analgesics, Long-acting
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 022272  Prod. No.: 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
PatentsExpirationPatented 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, 2023U-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, 2027U-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, 2027U-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, 2027U-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, 2023U-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 

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 == partial opioid agonist
NDA Applicant: TITAN PHARMS      NDA No.: 204442  Prod. No.: 001 DISC (EQ 80MG BASE/IMPLANT)
PatentsExpirationPatented 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, 2024U-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 == opioid agonist
NDA Applicant: ATHENA      NDA No.: 214044  Prod. No.: 001 RX (5MG/ML)
PatentsExpirationPatented Use
Pat. No. 11103452 DP* Tramadol hydrochloride solution
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 2, 2021
Sep 1, 2040U-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 == opioid agonist
NDA Applicant: OHEMO LIFE      NDA No.: 209777  Prod. No.: 001 DISC (5MG); 002 DISC (15MG); 003 DISC (30MG)
PatentsExpirationPatented 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 == opioid agonist
NDA Applicant: PURDUE PHARMA      NDA No.: 021745  Prod. No.: 001 DISC (100MG**); 002 DISC (200MG**); 003 DISC (300MG**)
PatentsExpirationPatented 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
SUBLOCADE (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist
NDA Applicant: INDIVIOR INC      NDA No.: 209819  Prod. No.: 001 RX (100MG/0.5ML (100MG/0.5ML))
PatentsExpirationPatented 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, 2032U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2035U-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 == partial opioid agonist
NDA Applicant: INDIVIOR INC      NDA No.: 209819  Prod. No.: 002 RX (300MG/1.5ML (200MG/ML))
PatentsExpirationPatented 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, 2032U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2031U-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, 2038U-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, 2035U-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 == partial opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: INDIVIOR INC      NDA No.: 022410  Prod. No.: 001 RX (EQ 2MG BASE;EQ 0.5MG BASE); 002 RX (EQ 8MG BASE;EQ 2MG BASE); 003 RX (EQ 4MG BASE;EQ 1MG BASE); 004 RX (EQ 12MG BASE;EQ 3MG BASE)
PatentsExpirationPatented 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, 2030U-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, 2024U-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, 2029U-1464: Treatment of opioid dependence/sublingual or buccal application
Pat. No. 9855221 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 3, 2018
Feb 14, 2022 
Pat. No. 9931305 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 3, 2018
Feb 14, 2022 
Pat. No. 10285910 DP* Sublingual and buccal film compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jun 7, 2019
Oct 11, 2022 
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, 2029U-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 == opioid agonist
NDA Applicant: BTCP PHARMA      NDA No.: 202788  Prod. No.: 001 RX (0.1MG); 003 RX (0.4MG); 004 RX (0.6MG); 006 RX (1.2MG); 007 RX (1.6MG)
PatentsExpirationPatented 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, 2030U-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, 2027U-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, 2027U-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, 2027U-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 == opioid agonist
NDA Applicant: BTCP PHARMA      NDA No.: 202788  Prod. No.: 002 RX (0.2MG)
PatentsExpirationPatented 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, 2030U-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, 2027U-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, 2027U-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, 2027U-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 == opioid agonist
NDA Applicant: BTCP PHARMA      NDA No.: 202788  Prod. No.: 005 RX (0.8MG)
PatentsExpirationPatented 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, 2030U-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, 2027U-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, 2027U-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, 2027U-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 == opioid antagonist == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 205777  Prod. No.: 001 DISC (5MG;10MG); 002 DISC (10MG;20MG)
PatentsExpirationPatented 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. 8969369 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 3, 2015
May 10, 2022U-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. 9056051 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 30, 2015
May 10, 2022U-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. 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. 9084729 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jul 22, 2015
May 10, 2022U-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. 9161937 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 27, 2015
May 10, 2022U-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. 9168252 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 27, 2015
May 10, 2022U-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. 9283216 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 15, 2016
May 10, 2022U-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. 9283221 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Mar 15, 2016
May 10, 2022U-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. 9345701 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: May 24, 2016
May 10, 2022U-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. 9511066 Abuse-resistant controlled-release opioid dosage form
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 6, 2016
May 10, 2022U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product
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, 2023U-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, 2023U-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 == opioid antagonist == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 205777  Prod. No.: 003 DISC (20MG;40MG)
PatentsExpirationPatented 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. 8969369 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Mar 3, 2015
May 10, 2022U-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. 9056051 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Jun 30, 2015
May 10, 2022U-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. 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. 9084729 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Jul 22, 2015
May 10, 2022U-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. 9161937 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 27, 2015
May 10, 2022U-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. 9168252 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 27, 2015
May 10, 2022U-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. 9283216 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Mar 15, 2016
May 10, 2022U-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. 9283221 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Mar 15, 2016
May 10, 2022U-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. 9345701 DP* Abuse-resistant controlled-release opioid dosage form
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: May 24, 2016
May 10, 2022U-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. 9511066 Abuse-resistant controlled-release opioid dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 003: Dec 6, 2016
May 10, 2022U-1921: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate by providing an abuse-deterrent oral controlled release combination drug product
Pat. No. 9522919 DS* DP* Oxycodone compositions
Claim Types: Formulation
Pat. Sub. Date(s): 003: Dec 20, 2016
Mar 30, 2025 

Analgesics:Opioid Analgesics, Long-acting
TROXYCA ER (CAPSULE, EXTENDED RELEASE) (ORAL) NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist == Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
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)
PatentsExpirationPatented 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, 2025U-1508: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment by orally administering a plurality of composite subunits as claimed

Analgesics:Opioid Analgesics, Long-acting
VANTRELA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough == opioid agonist
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)
PatentsExpirationPatented 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 == opioid agonist
NDA Applicant: MALLINCKRODT INC      NDA No.: 204031  Prod. No.: 001 DISC (325MG;7.5MG)
PatentsExpirationPatented 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, 2027U-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, 2029U-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, 2029U-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, 2029U-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, 2032U-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, 2032U-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 == opioid agonist
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)
PatentsExpirationPatented 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, 2025U-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, 2023U-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, 2023U-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, 2030U-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, 2036U-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, 2036U-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, 2030U-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, 2036U-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, 2023U-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, 2036U-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, 2030U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Analgesics:Opioid Analgesics, Long-acting
ZOHYDRO ER (CAPSULE, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [Has competitive generic]
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Respiratory Tract/ Pulmonary Agents:Cold-Cough == opioid agonist
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 )
PatentsExpirationPatented 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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2033U-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, 2034U-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, 2034U-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, 2033U-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, 2034U-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, 2033U-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, 2034U-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, 2033U-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, 2033U-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 == partial opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: OREXO US INC      NDA No.: 204242  Prod. No.: 001 RX (EQ 1.4MG BASE;EQ 0.36MG BASE)
PatentsExpirationPatented 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, 2030U-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, 2027U-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, 2032U-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 == partial opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: OREXO US INC      NDA No.: 204242  Prod. No.: 002 RX (EQ 5.7MG BASE;EQ 1.4MG BASE)
PatentsExpirationPatented 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, 2030U-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, 2027U-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, 2032U-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, 2032U-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 == partial opioid agonist == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
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)
PatentsExpirationPatented 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, 2030U-1425: Sublingual administration of a pharmaceutical composition comprising buprenorphine and naloxone
Pat. No. 8658198 DP* Non-abusa