Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

ABILIFY (SOLUTION) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 DISC (1MG/ML**)

Patents	Expiration	Change
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1529: Adjunctive treatment of major depressive disorder (MDD)	Dec 25, 2023	This patent is no longer listed for this product

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**); 004 DISC (20MG**); 005 DISC (30MG**)

Patents	Expiration	Change
Pat. No. 8580796 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Pat. Sub. Date(s): None Claim Types: New polymorph, salt or hydrate	Mar 25, 2023 *PED	This patent is no longer listed for this product
Pat. No. 8642760 DS* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Pat. Sub. Date(s): None Claim Types: Compound	Mar 25, 2023 *PED	This patent is no longer listed for this product
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1529: Adjunctive treatment of major depressive disorder (MDD)	Dec 25, 2023	This patent is no longer listed for this product

ABILIFY ASIMTUFII (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 217006  Prod. No.: 001 RX (720MG/2.4ML (300MG/ML)); 002 RX (960MG/3.2ML (300MG/ML))

Patents	Expiration	Change
Pat. No. 8338428 DP* Methods for administering aripiprazole Pat. Sub. Date(s): None Claim Types: Formulation; Method of administration Use Code: U-1530: Use of aripiprazole in extended release injectable suspension	Aug 6, 2023	This patent is no longer listed for this product
Pat. No. 8759351 DP* Methods for administering aripiprazole Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1530: Use of aripiprazole in extended release injectable suspension	Aug 6, 2023	This patent is no longer listed for this product

ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)

Patents	Expiration	Change
Pat. No. 8338428 DP* Methods for administering aripiprazole Pat. Sub. Date(s): None Claim Types: Formulation; Method of administration Use Code: U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia Use Code: U-543: Treatment of schizophrenia	Aug 6, 2023	This patent is no longer listed for this product
Pat. No. 8759351 DP* Methods for administering aripiprazole Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1530: Use of aripiprazole in extended release injectable suspension Use Code: U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia	Aug 6, 2023	This patent is no longer listed for this product

ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 207202  Prod. No.: 001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG); 005 RX (20MG); 006 RX (30MG)

Patents	Expiration	Change
Pat. No. 9387182 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1529: Adjunctive treatment of major depressive disorder (MDD)	Dec 25, 2023	This patent is no longer listed for this product

ACTOPLUS MET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: biguanide == peroxisome proliferator-activated receptor (PPAR) alpha agonist == peroxisome proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022024  Prod. No.: 001 DISC (1GM;EQ 15MG BASE); 002 DISC (1GM;EQ 30MG BASE)

Patents	Expiration	Change
Pat. No. 8470368 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Pat. Sub. Date(s): None Claim Types: Formulation	Sep 19, 2023	This patent is no longer listed for this product
Pat. No. 8668931 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Pat. Sub. Date(s): None Claim Types: Formulation	Sep 19, 2023	This patent is no longer listed for this product
Pat. No. 9060941 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Pat. Sub. Date(s): None Claim Types: Formulation	Sep 19, 2023	This patent is no longer listed for this product

ADDYI (TABLET) (ORAL) FLIBANSERIN
NDA Applicant: SPROUT PHARMS      NDA No.: 022526  Prod. No.: 001 RX (100MG)

Patents	Expiration	Change
Pat. No. 8227471 Treating sexual desire disorders with flibanserin Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD)	May 9, 2023	This patent is no longer listed for this product

ADVAIR HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 021254  Prod. No.: 001 RX (0.045MG/INH;EQ 0.021MG BASE/INH); 003 RX (0.23MG/INH;EQ 0.021MG BASE/INH)

Patents	Expiration	Change
Pat. No. 7832351 DP* Actuation indicator for a dispensing device Pat. Sub. Date(s): None Claim Types: Device	Dec 19, 2023 *PED	This patent is no longer listed for this product

AFINITOR DISPERZ (TABLET, FOR SUSPENSION) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS PHARM      NDA No.: 203985  Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (5MG)

Patents	Expiration	Change
Pat. No. 8617598 DP* Pharmaceutical compositions comprising colloidal silicon dioxide Pat. Sub. Date(s): None Claim Types: Formulation; Method of use; Process	Mar 27, 2023 *PED	This patent is no longer listed for this product

AGAMREE (SUSPENSION) (ORAL) VAMOROLONE
Drug Classes: corticosteroid
NDA Applicant: CATALYST PHARMS      NDA No.: 215239  Prod. No.: 001 RX (40MG/ML)

Patents	Expiration	Change
Pat. No. 11690853 Non-hormonal steroid modulators of NF-κβ for treatment of disease Pat. Sub. Date(s): 001: Nov 21, 2023 Claim Types: Method of use Use Code: U-3747: Treatment of Duchenne muscular dystrophy	Mar 7, 2033	New expiration date. Was previously Jun 29, 2036

AIRDUO RESPICLICK; AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.: 208799  Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH); 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH); 004 RX (0.055MG/INH;EQ 0.014MG BASE/INH); 005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX (0.232MG/INH;EQ 0.014MG BASE/INH)

Patents	Expiration	Change
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Pat. Sub. Date(s): None Claim Types: Device	Nov 6, 2023 *PED	This patent is no longer listed for this product

AKYNZEO (CAPSULE) (ORAL) NETUPITANT; PALONOSETRON HYDROCHLORIDE
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 205718  Prod. No.: 001 RX (300MG;EQ 0.5MG BASE)

Patents	Expiration	Change
Pat. No. 6297375 DS* [Extended 1119 days (3.1 years)] 4-phenyl-pyridine derivatives Pat. Sub. Date(s): None Claim Types: Compound	Mar 17, 2023	This patent is no longer listed for this product

ANNOVERA (RING) (VAGINAL) ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Drug Classes: progestin/estrogen CHC
NDA Applicant: MAYNE PHARMA      NDA No.: 209627  Prod. No.: 001 RX (0.013MG/24HR;0.15MG/24HR)

Patents	Expiration	Change
Pat. No. 11850251 System for providing birth control Pat. Sub. Date(s): 001: Feb 1, 2024 Claim Types: Method of use Use Code: U-3785: Method of preventing pregnancy by inserting a vaginal system containing 103 mg of segesterone acetate and 17.4 mg of ethinyl estradiol for up to 1thirteen 21/7-day (in/out) cycles	Jun 21, 2039	New patent for this product

ANORO ELLIPTA (POWDER) (INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes: anticholinergic == beta-2 adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 203975  Prod. No.: 001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)

Patents	Expiration	Change
Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Pat. Sub. Date(s): None Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Use Code: U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.	Mar 23, 2023	This patent is no longer listed for this product

APONVIE (EMULSION) (INTRAVENOUS) APREPITANT
Drug Classes: substance P/neurokinin-1 (NK-1) receptor antagonist
NDA Applicant: HERON THERAPS INC      NDA No.: 216457  Prod. No.: 001 RX (32MG/4.4ML (7.2MG/ML))

Patents	Expiration	Change
Pat. No. 11878074 Methods of use of emulsion formulations of an NK-1 receptor antagonist Pat. Sub. Date(s): 001: Feb 6, 2024 Claim Types: Method of use Use Code: U-3787: A method for preventing post-operative nausea and vomiting	Sep 18, 2035	New patent for this product

ARMONAIR RESPICLICK; ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.: 208798  Prod. No.: 004 RX (0.055MG/INH); 005 RX (0.113MG/INH); 006 RX (0.232MG/INH) NDA No.: 208798  Prod. No.: 001 DISC (0.055MG/INH); 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH); 007 DISC (0.03MG/INH); 008 DISC (0.03MG/INH)

Patents	Expiration	Change
Pat. No. 7540282 DP* Reservoir pressure system for medicament inhaler Pat. Sub. Date(s): None Claim Types: Device	Nov 6, 2023 *PED	This patent is no longer listed for this product

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY); 002 RX (EQ 0.15MG/DELIVERY); 003 RX (EQ 0.1MG/DELIVERY)

Patents	Expiration	Change
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Method of administration	Feb 1, 2026	This patent is no longer listed for this product
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Feb 1, 2026	This patent is no longer listed for this product

AXIRON (SOLUTION, METERED) (TRANSDERMAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ELI LILLY AND CO      NDA No.: 022504  Prod. No.: 001 DISC (30MG/1.5ML ACTUATION**)

Patents	Expiration	Change
Pat. No. 8784878 DP* Transdermal delivery rate control using amorphous pharmaceutical compositions Pat. Sub. Date(s): None Claim Types: Formulation; Method of administration Use Code: U-1545: A method of transdermally delivering testosterone	Jul 13, 2023	This patent is no longer listed for this product

BELRAPZO (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.: 205580  Prod. No.: 001 RX (100MG/4ML (25MG/ML))

Patents	Expiration	Change
Pat. No. 11872214 DP* Formulations of Bendamustine Pat. Sub. Date(s): 001: Jan 16, 2024 Claim Types: Drug in a container; Formulation	Jan 28, 2031	New patent for this product

BENDEKA (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.: 208194  Prod. No.: 001 RX (100MG/4ML (25MG/ML))

Patents	Expiration	Change
Pat. No. 11872214 DP* Formulations of Bendamustine Pat. Sub. Date(s): 001: Jan 16, 2024 Claim Types: Drug in a container; Formulation	Jan 28, 2031	New patent for this product

BEPREVE (SOLUTION/DROPS) (OPHTHALMIC) BEPOTASTINE BESILATE [GENERIC AT]
Drug Classes: histamine-1 (H1) receptor antagonist
NDA Applicant: BAUSCH AND LOMB INC      NDA No.: 022288  Prod. No.: 001 RX (1.5%)

Patents	Expiration	Change
Pat. No. 8877168 DP* Aqueous liquid preparations and light-stabilized aqueous liquid preparations Pat. Sub. Date(s): None Claim Types: Formulation	Jul 30, 2023	This patent is no longer listed for this product

BIJUVA (CAPSULE) (ORAL) ESTRADIOL; PROGESTERONE
Drug Classes: estrogen == progesterone == progestin
NDA Applicant: MAYNE PHARMA      NDA No.: 210132  Prod. No.: 001 RX (1MG;100MG); 002 RX (0.5MG;100MG)

Patents	Expiration	Change
Pat. No. 11865179 DS* DP* Progesterone formulations having a desirable PK profile Pat. Sub. Date(s): All strengths: Feb 1, 2024 Claim Types: Formulation	Nov 21, 2032	New patent for this product

BINOSTO (TABLET, EFFERVESCENT) (ORAL) ALENDRONATE SODIUM
NDA Applicant: RADIUS      NDA No.: 202344  Prod. No.: 001 RX (EQ 70MG BASE)

Patents	Expiration	Change
Pat. No. 7488496 DS* DP* Effervescent compositions comprising bisphosphonates and methods related thereto Pat. Sub. Date(s): None Claim Types: Formulation	Aug 11, 2023	This patent is no longer listed for this product
Pat. No. 7964212 DS* DP* Effervescent compositions comprising phosphonates and methods related thereto Pat. Sub. Date(s): None Claim Types: Formulation	Mar 6, 2023	This patent is no longer listed for this product

BRAFTOVI (CAPSULE) (ORAL) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.: 210496  Prod. No.: 001 DISC (50MG)

Patents	Expiration	Change
Pat. No. 8501758 DS* DP* Compounds and compositions as protein kinase inhibitors Pat. Sub. Date(s): None Claim Types: Compound; Composition; Formulation	Mar 4, 2031	This patent is no longer listed for this product

BRAFTOVI (CAPSULE) (ORAL) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.: 210496  Prod. No.: 002 RX (75MG)

Patents	Expiration	Change
Pat. No. 8501758 DS* DP* Compounds and compositions as protein kinase inhibitors Pat. Sub. Date(s): None Claim Types: Compound; Composition; Formulation	Aug 27, 2030	This patent is no longer listed for this product

BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 204275  Prod. No.: 001 RX (0.1MG/INH;EQ 0.025MG BASE/INH)

Patents	Expiration	Change
Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Pat. Sub. Date(s): None Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Use Code: U-1548: For the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, also to reduce exacerbations of COPD in patients with a history of exacerbations Use Code: U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older	Mar 23, 2023	This patent is no longer listed for this product

BREO ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: GLAXO GRP LTD      NDA No.: 204275  Prod. No.: 002 RX (0.2MG/INH;EQ 0.025MG BASE/INH)

Patents	Expiration	Change
Pat. No. RE44874 DS* DP* Phenethanolamine derivatives for treatment of respiratory diseases Pat. Sub. Date(s): None Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Use Code: U-1691: Indicated for the once-daily inhaled treatment for asthma in adults aged 18 years and older	Mar 23, 2023	This patent is no longer listed for this product

BROMFENAC SODIUM (SOLUTION/DROPS) (OPHTHALMIC) BROMFENAC SODIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: LUPIN LTD      NDA No.: 206027  Prod. No.: 001 RX (EQ 0.07% ACID)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Jul 6, 2024	New exclusivity for this product

BRUKINSA (CAPSULE) (ORAL) ZANUBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: BEIGENE      NDA No.: 213217  Prod. No.: 001 RX (80MG)

Patents	Expiration	Change
Pat. No. 11851437 DS* DP* Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Pat. Sub. Date(s): 001: Jan 23, 2024 Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition	Aug 15, 2037	New patent for this product

BYDUREON BCISE (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.: 209210  Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))

Patents	Expiration	Change
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Pat. Sub. Date(s): None Claim Types: Product-by-process; Process	Apr 9, 2023 *PED	This patent is no longer listed for this product

BYDUREON; BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.: 022200  Prod. No.: 001 DISC (2MG/VIAL); 002 DISC (2MG)

Patents	Expiration	Change
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby Pat. Sub. Date(s): None Claim Types: Product-by-process; Process	Apr 9, 2023 *PED	This patent is no longer listed for this product

CABENUVA KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR; RILPIVIRINE
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibito == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 212888  Prod. No.: 001 RX (400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)); 002 RX (600MG/3ML (200MG/ML);900MG/3ML (300MG/ML))

Patents	Expiration	Change
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Pat. Sub. Date(s): None Claim Types: Compound; Composition; Process	Apr 11, 2023	This patent is no longer listed for this product

CAPLYTA (CAPSULE) (ORAL) LUMATEPERONE TOSYLATE
Drug Classes: atypical antipsychotic
NDA Applicant: INTRA-CELLULAR      NDA No.: 209500  Prod. No.: 001 RX (EQ 42MG BASE)

Patents	Expiration	Change
Pat. No. 8598119 DLR* Methods and compositions for sleep disorders and other disorders Pat. Sub. Date(s): 001: Jan 17, 2020 Claim Types: Method of use Use Code: U-543: Treatment of schizophrenia	Dec 28, 2029	New Delisting Request flag

CHLORAPREP ONE-STEP (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO      NDA No.: 020832  Prod. No.: 006 OTC (2%;70% (26ML))

Patents	Expiration	Change
Pat. No. 7182536 DP* Antiseptic applicator with mechanism for fracturing multiple ampoules Pat. Sub. Date(s): None Claim Types: Device	Dec 30, 2023	This patent is no longer listed for this product

CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO      NDA No.: 020832  Prod. No.: 002 OTC (2%;70% (26ML))

Patents	Expiration	Change
Pat. No. 6729786 DP* Liquid applicator for coloring a liquid Pat. Sub. Date(s): None Claim Types: Device	Mar 14, 2023	This patent is no longer listed for this product
Pat. No. 7182536 DP* Antiseptic applicator with mechanism for fracturing multiple ampoules Pat. Sub. Date(s): None Claim Types: Device	Dec 30, 2023	This patent is no longer listed for this product
Pat. No. 7241065 DP* Applicator for coloring antiseptic Pat. Sub. Date(s): None Claim Types: Device	Mar 14, 2023	This patent is no longer listed for this product

CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO      NDA No.: 020832  Prod. No.: 005 OTC (2%;70% (10.5ML))

Patents	Expiration	Change
Pat. No. 6729786 DP* Liquid applicator for coloring a liquid Pat. Sub. Date(s): None Claim Types: Device	Mar 14, 2023	This patent is no longer listed for this product
Pat. No. 7241065 DP* Applicator for coloring antiseptic Pat. Sub. Date(s): None Claim Types: Device	Mar 14, 2023	This patent is no longer listed for this product

CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO      NDA No.: 020832  Prod. No.: 007 OTC (2%;70% (3ML))

Patents	Expiration	Change
Pat. No. 6729786 DP* Liquid applicator for coloring a liquid Pat. Sub. Date(s): None Claim Types: Device	Mar 14, 2023	This patent is no longer listed for this product
Pat. No. 7241065 DP* Applicator for coloring antiseptic Pat. Sub. Date(s): None Claim Types: Device	Mar 14, 2023	This patent is no longer listed for this product

CHLORHEXIDINE GLUCONATE (CLOTH) (TOPICAL) CHLORHEXIDINE GLUCONATE
NDA Applicant: SAGE PRODS      NDA No.: 021669  Prod. No.: 001 OTC (2%)

Patents	Expiration	Change
Pat. No. 7595021 DP* Method of providing alcohol-free disinfection Pat. Sub. Date(s): None Claim Types: Method of administration Use Code: U-1022: For the preparation of skin prior to surgery; helps reduce bacteria that can potentially cause skin infection	May 12, 2023	This patent is no longer listed for this product

CLINDESSE (CREAM) (VAGINAL) CLINDAMYCIN PHOSPHATE [Has competitive generic]
Drug Classes: lincosamide antibacterial
NDA Applicant: PADAGIS US      NDA No.: 050793  Prod. No.: 001 RX (EQ 2% BASE)

Patents	Expiration	Change
Pat. No. 6899890 DP* Bioadhesive drug delivery system Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-137: Method of treating bacterial vaginosis	Apr 27, 2023	This patent is no longer listed for this product

COMPLERA (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 202123  Prod. No.: 001 RX (200MG;EQ 25MG BASE;300MG)

Patents	Expiration	Change
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Pat. Sub. Date(s): None Claim Types: Compound; Composition; Process	Apr 11, 2023	This patent is no longer listed for this product

COREG CR (CAPSULE, EXTENDED RELEASE) (ORAL) CARVEDILOL PHOSPHATE [GENERIC AB]
Drug Classes: 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)

Patents	Expiration	Change
Pat. No. 7268156 DS* DP* Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment Pat. Sub. Date(s): None Claim Types: New polymorph, salt or hydrate; Method of use; Composition Use Code: U-313: Treatment of congestive heart failure Use Code: U-3: Treatment of hypertension	Dec 27, 2023 *PED	This patent is no longer listed for this product

CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS      NDA No.: 207500  Prod. No.: 001 RX (186MG); 002 RX (74.5MG)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Jun 8, 2027 PED	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-458: Treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater	Dec 8, 2030	New exclusivity for this product

CRESEMBA (POWDER) (INTRAVENOUS) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS      NDA No.: 207501  Prod. No.: 001 RX (372MG)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Jun 8, 2027 PED	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-453: Treatment of invasive mucormycosis in pediatric patients 1 year of age and older	Jun 8, 2031 PED	New expiration date. Was previously Dec 8, 2030
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-459: Treatment of invasive aspergillosis in pediatric patients 1 year of age and older	Jun 8, 2031 PED	New exclusivity for this product

CYCLOSET (TABLET) (ORAL) BROMOCRIPTINE MESYLATE
Drug Classes: ergot derivative
NDA Applicant: VEROSCIENCE      NDA No.: 020866  Prod. No.: 001 RX (EQ 0.8MG BASE)

Patents	Expiration	Change
Pat. No. 7888310 Methods of identifying responders to dopamine agonist therapy Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors	Jul 25, 2023	This patent is no longer listed for this product
Pat. No. 8137992 Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof Pat. Sub. Date(s): None Claim Types: Method of use; Method of administration Use Code: U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors	Jul 25, 2023	This patent is no longer listed for this product
Pat. No. 8137993 Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof Pat. Sub. Date(s): None Claim Types: Method of use; Method of administration Use Code: U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors	Jul 25, 2023	This patent is no longer listed for this product
Pat. No. 8137994 Methods of identifying responders to dopamine agonist therapy and treating metabolic conditions thereof Pat. Sub. Date(s): None Claim Types: Method of use; Method of administration Use Code: U-1433: Improvements of glycemic control in individuals with Type 2 diabetes who have one or more specified cardiovascular risk factors	Jul 25, 2023	This patent is no longer listed for this product

DALIRESP (TABLET) (ORAL) ROFLUMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 022522  Prod. No.: 001 RX (500MCG); 002 RX (250MCG)

Patents	Expiration	Change
Pat. No. 8431154 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidone as excipient Pat. Sub. Date(s): None Claim Types: Product-by-process	Feb 19, 2023	This patent is no longer listed for this product
Pat. No. 9468598 DP* Oral dosage form containing a PDE 4 inhibitor as an active ingredient and polyvinylpyrrolidon as excipient Pat. Sub. Date(s): None Claim Types: Formulation	Feb 19, 2023	This patent is no longer listed for this product

DALVANCE (POWDER) (INTRAVENOUS) DALBAVANCIN HYDROCHLORIDE
Drug Classes: lipoglycopeptide antibacterial
NDA Applicant: ABBVIE      NDA No.: 021883  Prod. No.: 001 RX (EQ 500MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 7115564 DP* Stable pharmaceutical compositions of dalbavancin and methods of administration Pat. Sub. Date(s): None Claim Types: Formulation	Nov 14, 2023	This patent is no longer listed for this product
Pat. No. 7119061 DP* Dalbavancin compositions for treatment of bacterial infections Pat. Sub. Date(s): None Claim Types: Formulation	Nov 14, 2023	This patent is no longer listed for this product
Pat. No. 8143212 Dalbavancin compositions for treatment of bacterial infections Pat. Sub. Date(s): None Claim Types: Method of administration Use Code: U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin.	Nov 14, 2023	This patent is no longer listed for this product

DEFENCATH (SOLUTION) (N/A) HEPARIN SODIUM; TAUROLIDINE
Drug Classes: anticoagulant == unfractionated heparin
NDA Applicant: CORMEDIX      NDA No.: 214520  Prod. No.: 001 RX (3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)); 002 RX (5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Nov 15, 2033 GAIN	New exclusivity for this product

DEFINITY; DEFINITY RT (INJECTABLE) (INTRAVENOUS) PERFLUTREN
Drug Classes: ultrasound contrast agent
NDA Applicant: LANTHEUS MEDCL      NDA No.: 021064  Prod. No.: 001 RX (13.04MG/2ML (6.52MG/ML)); 002 RX (13.04MG/2ML (6.52MG/ML))

Patents	Expiration	Change
Pat. No. 11857646 Methods for making ultrasound contrast agents Pat. Sub. Date(s): All strengths: Jan 12, 2024 Claim Types: Diagnostic or surgical method; Process Use Code: U-665: Method of using the drug substance/drug product for ultrasound imaging	Mar 16, 2037	New patent for this product

DESCOVY (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208215  Prod. No.: 002 RX (120MG;EQ 15MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-457: Treatment of HIV-1 infection in pediatric patients under 12 years of age weighing at least 14 kg to less than 25 kg	Jan 7, 2029	New exclusivity for this product

DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022287  Prod. No.: 001 RX (30MG); 002 RX (60MG)

Patents	Expiration	Change
Pat. No. 6664276 DS* DP* [Extended 959 days (2.6 years)] Benzimidazole compound crystal Pat. Sub. Date(s): None Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Use Code: U-1507: To maintain healing of EE and relief of heartburn Use Code: U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks Use Code: U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months Use Code: U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks	Jul 30, 2023 *PED	This patent is no longer listed for this product

DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 208056  Prod. No.: 001 DISC (30MG)

Patents	Expiration	Change
Pat. No. 6664276 DS* DP* [Extended 959 days (2.6 years)] Benzimidazole compound crystal Pat. Sub. Date(s): None Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Use Code: U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months Use Code: U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks	Jul 30, 2023 *PED	This patent is no longer listed for this product

DEXYCU KIT (SUSPENSION) (INTRAOCULAR) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: EYEPOINT PHARMS      NDA No.: 208912  Prod. No.: 001 RX (9%)

Patents	Expiration	Change
Pat. No. 6960346 DP* Vehicles for delivery of biologically active substances Pat. Sub. Date(s): None Claim Types: Formulation; Kit	Jul 3, 2023	This patent is no longer listed for this product

DIFFERIN (GEL) (TOPICAL) ADAPALENE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 021753  Prod. No.: 001 RX (0.3%)

Patents	Expiration	Change
Pat. No. 7834060 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1078: Treatment of acne	Mar 12, 2023	This patent is no longer listed for this product
Pat. No. 7838558 DP* Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Pat. Sub. Date(s): None Claim Types: Formulation	Mar 12, 2023	This patent is no longer listed for this product
Pat. No. 7868044 Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1078: Treatment of acne	Mar 12, 2023	This patent is no longer listed for this product
Pat. No. 8703820 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1078: Treatment of acne	Mar 12, 2023	This patent is no longer listed for this product

DIFICID (FOR SUSPENSION) (ORAL) FIDAXOMICIN
Drug Classes: macrolide antibacterial
NDA Applicant: CUBIST PHARMS LLC      NDA No.: 213138  Prod. No.: 001 RX (40MG/ML)

Patents	Expiration	Change
Pat. No. 8586551 DS* DP* 18-membered macrocycles and analogs thereof Pat. Sub. Date(s): 001: Feb 21, 2020 Claim Types: Compound; Composition; Formulation	Jan 15, 2024 *PED	New expiration date. Was previously Jan 23, 2024 *PED

DOPTELET (TABLET) (ORAL) AVATROMBOPAG MALEATE
NDA Applicant: AKARX INC      NDA No.: 210238  Prod. No.: 001 RX (EQ 20MG BASE)

Patents	Expiration	Change
Pat. No. 7638536 DS* DP* 2-Acylaminothiazole derivative or salt thereof Pat. Sub. Date(s): 001: Jun 15, 2018 Claim Types: Compound; Composition	Jul 28, 2027	New expiration date. Was previously May 5, 2025
Pat. No. 8338429 2-acylaminothiazole derivative or salt thereof Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-2577: Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment	Jun 30, 2023	This patent is no longer listed for this product
Pat. No. 8765764 2-acylaminothiazole derivative or salt thereof Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET Use Code: U-2578: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure	Jan 15, 2023	This patent is no longer listed for this product

DUTREBIS (TABLET) (ORAL) LAMIVUDINE; RALTEGRAVIR POTASSIUM
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcript == human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MERCK SHARP DOHME      NDA No.: 206510  Prod. No.: 001 DISC (150MG;EQ 300MG BASE)

Patents	Expiration	Change
Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1663: Treatment of HIV-1 infection	Apr 21, 2023 *PED	This patent is no longer listed for this product
Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1663: Treatment of HIV-1 infection	Apr 21, 2023 *PED	This patent is no longer listed for this product
Pat. No. 7820660 DS* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Formulation	Apr 25, 2023	This patent is no longer listed for this product

DYMISTA (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist == corticosteroid
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 202236  Prod. No.: 001 RX (0.137MG/SPRAY;0.05MG/SPRAY)

Patents	Expiration	Change
Pat. No. 9259428 Combination of azelastine and fluticasone for nasal administration Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-644: Treatment of seasonal allergic rhinitis	Dec 13, 2023 *PED	This patent is no longer listed for this product
Pat. No. 9901585 DP* Combination of azelastine and fluticasone for nasal administration Pat. Sub. Date(s): None Claim Types: Formulation	Jun 13, 2023	This patent is no longer listed for this product

EDURANT (TABLET) (ORAL) RILPIVIRINE HYDROCHLORIDE
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: JANSSEN PRODS      NDA No.: 202022  Prod. No.: 001 RX (EQ 25MG BASE)

Patents	Expiration	Change
Pat. No. 7125879 DS* DP* [Extended 986 days (2.7 years)] HIV inhibiting pyrimidines derivatives Pat. Sub. Date(s): 001: Jun 16, 2011 Claim Types: Compound; Composition; Method of use; Formulation Use Code: U-1153: In combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naive adult patients, as set forth in the labeling, including I&U section Use Code: U-1307: In combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naive adult patients with HIV-1 RNA less than or equal to 100,000 at the start of therapy Use Code: U-1740: In combination with other antiretroviral agents for the treatment of hiv-1 infection in treatment-naive patients with hiv-1 rna less than or equal to 100,000 at the start of therapy Use Code: U-3353: Treatment in combination with cabotegravir of HIV-1 infection in adults and adolescents 12 and older to replace current regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure	Oct 21, 2025 *PED	New expiration date. Was previously Apr 21, 2025
Pat. No. 7638522 DP* Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino] benzonitrile Pat. Sub. Date(s): None Claim Types: Formulation	Apr 14, 2023	This patent is no longer listed for this product
Pat. No. 8080551 DS* DP* HIV inhibiting pyrimidines derivatives Pat. Sub. Date(s): None Claim Types: Compound; Composition; Process	Apr 11, 2023	This patent is no longer listed for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 021379  Prod. No.: 001 RX (22.5MG)

Patents	Expiration	Change
Pat. No. 8470359 DS* DP* Sustained release polymer Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-621: Method of treating cancer	Oct 15, 2023	This patent is no longer listed for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 021488  Prod. No.: 001 RX (30MG)

Patents	Expiration	Change
Pat. No. 8470359 DS* DP* Sustained release polymer Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-621: Method of treating cancer	Oct 15, 2023	This patent is no longer listed for this product

ELIGARD KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 021731  Prod. No.: 001 RX (45MG)

Patents	Expiration	Change
Pat. No. 8470359 DS* DP* Sustained release polymer Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-621: Method of treating cancer	Oct 15, 2023	This patent is no longer listed for this product

EMPAVELI (SOLUTION) (SUBCUTANEOUS) PEGCETACOPLAN
Drug Classes: complement inhibitor
NDA Applicant: APELLIS PHARMS      NDA No.: 215014  Prod. No.: 001 RX (1080MG/20ML (54MG/ML))

Patents	Expiration	Change
Pat. No. 11844841 DP* Dosing regimens and related compositions and methods Pat. Sub. Date(s): 001: Jan 16, 2024 Claim Types: Method of use; Formulation Use Code: U-3172: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan Use Code: U-3173: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan twice weekly Use Code: U-3174: Treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) by administration of 1080 mg of pegcetacoplan every three days	Dec 9, 2038	New patent for this product

ENTRESTO (TABLET) (ORAL) SACUBITRIL; VALSARTAN
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 207620  Prod. No.: 001 RX (24MG;26MG); 002 RX (49MG;51MG); 003 RX (97MG;103MG)

Patents	Expiration	Change
Pat. No. 8404744 DP* Methods of treatment and pharmaceutical composition Pat. Sub. Date(s): None Claim Types: Formulation	Jul 14, 2023 *PED	This patent is no longer listed for this product
Pat. No. 8796331 Methods of treatment and pharmaceutical composition Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1723: Treatment of heart failure	Jul 14, 2023 *PED	This patent is no longer listed for this product

EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
NDA Applicant: JAZZ PHARMS RES      NDA No.: 210365  Prod. No.: 001 RX (100MG/ML)

Patents	Expiration	Change
Pat. No. 11865102 DS* DP* Cannabidiol preparations and its uses Pat. Sub. Date(s): 001: Jan 30, 2024 Claim Types: Formulation; Method of use Use Code: U-2781: Use for the treatment of seizures in patients with Dravet syndrome Use Code: U-3236: Use for the treatment of seizures associated with Lennox-Gastaut syndrome Use Code: U-3277: Use for the treatment of seizures associated with tuberous sclerosis complex	Apr 26, 2039	New patent for this product

EPSOLAY (CREAM) (TOPICAL) BENZOYL PEROXIDE
NDA Applicant: GALDERMA LABS LP      NDA No.: 214510  Prod. No.: 001 RX (5%)

Patents	Expiration	Change
Pat. No. 11865100 Method for treatment of rosacea in patients aged 65 years and older Pat. Sub. Date(s): 001: Feb 5, 2024 Claim Types: Dosaage regimen; Formulation; Formulation claimed by its inherent performace characteristics Use Code: U-3357: Topical treatment of inflammatory lesions of rosacea in adults 65 years of age and older	Feb 19, 2040	New patent for this product

EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: 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))

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-929: Indicated to produce postsurgical regional analgesia in adults via asciatic nerve block in the popliteal fossa and via an adductor canal block	Nov 9, 2026	New exclusivity for this product

EYSUVIS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: corticosteroid
NDA Applicant: ALCON LABS INC      NDA No.: 210933  Prod. No.: 001 RX (0.25%)

Patents	Expiration	Change
Pat. No. 11872318 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Pat. Sub. Date(s): 001: Feb 1, 2024 Claim Types: Formulation	May 3, 2033	New patent for this product

FABHALTA (CAPSULE) (ORAL) IPTACOPAN HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.: 218276  Prod. No.: 001 RX (EQ 200MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Dec 5, 2028	New exclusivity for this product

FENSOLVI KIT (POWDER) (SUBCUTANEOUS) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: TOLMAR      NDA No.: 213150  Prod. No.: 001 RX (45MG)

Patents	Expiration	Change
Pat. No. 8470359 DS* DP* Sustained release polymer Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-2940: Method of treating pediatric patients 2 years of age and older with central precocious puberty	Oct 15, 2023	This patent is no longer listed for this product

FILSUVEZ (GEL) (TOPICAL) BIRCH TRITERPENES
NDA Applicant: CHIESI      NDA No.: 215064  Prod. No.: 001 RX (10%)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-460: Treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older	Dec 18, 2030	New exclusivity for this product

FINACEA (AEROSOL, FOAM) (TOPICAL) AZELAIC ACID
NDA Applicant: LEO PHARMA AS      NDA No.: 207071  Prod. No.: 001 RX (15%)

Patents	Expiration	Change
Pat. No. 8722021 DP* Foamable carriers Pat. Sub. Date(s): None Claim Types: Formulation	Oct 24, 2023	This patent is no longer listed for this product
Pat. No. 8900554 DP* Foamable composition and uses thereof Pat. Sub. Date(s): None Claim Types: Composition	Oct 24, 2023	This patent is no longer listed for this product
Pat. No. 10322085 DP* Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof Pat. Sub. Date(s): None Claim Types: Formulation	Oct 24, 2023	This patent is no longer listed for this product

FLOVENT HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: GLAXO GRP LTD      NDA No.: 021433  Prod. No.: 001 RX (0.22MG/INH); 002 RX (0.11MG/INH)

Patents	Expiration	Change
Pat. No. 7832351 DP* Actuation indicator for a dispensing device Pat. Sub. Date(s): None Claim Types: Device	Dec 19, 2023 *PED	This patent is no longer listed for this product

FLUOROMETHOLONE (SUSPENSION/DROPS) (OPHTHALMIC) FLUOROMETHOLONE [GENERIC AB]
Drug Classes: corticosteroid
NDA Applicant: AMNEAL      NDA No.: 216348  Prod. No.: 001 RX (0.1%)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Jul 7, 2024	New exclusivity for this product

FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: AVEO PHARMS      NDA No.: 212904  Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)

Patents	Expiration	Change
Pat. No. 7166722 DS* DP* N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n'-(5-methyl-3-isoxaz- olyl)urea salt in crystalline form Pat. Sub. Date(s): All strengths: Apr 6, 2021 Claim Types: New polymorph, salt or hydrate; Process	Nov 16, 2024	New expiration date. Was previously Nov 16, 2023; New Drug Substance/Drug Product flag

GATTEX KIT (POWDER) (SUBCUTANEOUS) TEDUGLUTIDE RECOMBINANT
Drug Classes: glucagon-like peptide-2 (GLP-2) analog
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 203441  Prod. No.: 001 RX (5MG/VIAL)

Patents	Expiration	Change
Pat. No. 7056886 DP* GLP-2 formulations Pat. Sub. Date(s): None Claim Types: Formulation; Process; Kit; Method of use Use Code: U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support	Mar 18, 2023 *PED	This patent is no longer listed for this product

GAVRETO (CAPSULE) (ORAL) PRALSETINIB
Drug Classes: kinase inhibitor
NDA Applicant: GENENTECH INC      NDA No.: 213721  Prod. No.: 001 RX (100MG)

Patents	Expiration	Change
Pat. No. 11872192 RET inhibitor for use in treating cancer having a RET alteration Pat. Sub. Date(s): 001: Feb 6, 2024 Claim Types: Method of use Use Code: U-2952: Treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test	Apr 3, 2039	New patent for this product

GIVLAARI (SOLUTION) (SUBCUTANEOUS) GIVOSIRAN SODIUM
Drug Classes: aminolevulinate synthase 1-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC      NDA No.: 212194  Prod. No.: 001 RX (EQ 189MG BASE/ML (EQ 189MG BASE/ML))

Patents	Expiration	Change
Pat. No. 9708610 DS* DP* Compositions comprising alternating 2'-modified nucleosides for use in gene modulation Pat. Sub. Date(s): None Claim Types: Composition; Method of use Use Code: U-2672: Treatment of acute hepatic porphyria	Jan 1, 2024	This patent is no longer listed for this product

GLUMETZA (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE [GENERIC AB3]
Drug Classes: biguanide
NDA Applicant: SANTARUS INC      NDA No.: 021748  Prod. No.: 002 RX (1GM)

Patents	Expiration	Change
Pat. No. 8323692 DP* Controlled release dosage forms Pat. Sub. Date(s): None Claim Types: Formulation	Mar 30, 2023	This patent is no longer listed for this product

GLYXAMBI (TABLET) (ORAL) EMPAGLIFLOZIN; LINAGLIPTIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 206073  Prod. No.: 001 RX (10MG;5MG); 002 RX (25MG;5MG)

Patents	Expiration	Change
Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1651: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin	Aug 12, 2023	This patent is no longer listed for this product
Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1653: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin (with or without metformin) Use Code: U-1654: Method of treating Type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin (with or without insulin or a sulfonylurea)	Aug 12, 2023	This patent is no longer listed for this product

HYSINGLA ER (TABLET, EXTENDED RELEASE) (ORAL) HYDROCODONE BITARTRATE [GENERIC AB]
Drug Classes: 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)

Patents	Expiration	Change
Pat. No. 8309060 DP* Abuse-proofed dosage form Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.	Nov 20, 2023	This patent is no longer listed for this product
Pat. No. 9675610 DP* Abuse-proofed dosage form Pat. Sub. Date(s): None Claim Types: Formulation	Jun 16, 2023	This patent is no longer listed for this product
Pat. No. 10130591 DP* Abuse-proofed dosage form Pat. Sub. Date(s): None Claim Types: Method of use; Product-by-process Use Code: U-1819: Management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate	Nov 20, 2023	This patent is no longer listed for this product
Pat. No. 10369109 DP* Abuse-proofed dosage form Pat. Sub. Date(s): None Claim Types: Formulation	Jun 16, 2023	This patent is no longer listed for this product

IBRANCE (CAPSULE) (ORAL) PALBOCICLIB
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER      NDA No.: 207103  Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)

Patents	Expiration	Change
Pat. No. 6936612 DS* DP* 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones Pat. Sub. Date(s): None Claim Types: Compound; Composition	Jan 16, 2023	This patent is no longer listed for this product
Pat. No. 7208489 DS* DP* DLR* 2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones Pat. Sub. Date(s): None Claim Types: Compound; Composition	Jan 16, 2023	This patent is no longer listed for this product
Pat. No. 7456168 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1998: Treating HR-pos., HER2-neg. advanced or metastatic breast cancer with palbociclib in combo with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or fulvestrant in women with disease progression after endocrine therapy Use Code: U-2515: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men, or with fulvestrant in pts with disease progression after endocrine therapy Use Code: U-3501: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor in pts as initial endocrine-based therapy or with fulvestrant with disease progression after endocrine therapy	Jan 16, 2023	This patent is no longer listed for this product

IBRANCE (TABLET) (ORAL) PALBOCICLIB
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER      NDA No.: 212436  Prod. No.: 001 RX (75MG); 002 RX (100MG); 003 RX (125MG)

Patents	Expiration	Change
Pat. No. 6936612 DS* DP* 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones Pat. Sub. Date(s): None Claim Types: Compound; Composition	Jan 16, 2023	This patent is no longer listed for this product
Pat. No. 7456168 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-2515: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men, or with fulvestrant in pts with disease progression after endocrine therapy Use Code: U-3501: Palbociclib for HR-pos. HER2-neg. advanced or metastatic breast cancer in combo with an aromatase inhibitor in pts as initial endocrine-based therapy or with fulvestrant with disease progression after endocrine therapy	Jan 16, 2023	This patent is no longer listed for this product

IDOSE TR (IMPLANT) (INTRACAMERAL) TRAVOPROST
Drug Classes: prostaglandin analog
NDA Applicant: GLAUKOS      NDA No.: 218010  Prod. No.: 001 RX (75MCG)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Dec 13, 2026	New exclusivity for this product

IGALMI (FILM) (BUCCAL, SUBLINGUAL) DEXMEDETOMIDINE HYDROCHLORIDE
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: BIOXCEL      NDA No.: 215390  Prod. No.: 001 RX (EQ 0.12MG BASE); 002 RX (EQ 0.18MG BASE)

Patents	Expiration	Change
Pat. No. 11890272 Non-sedating Dexmedetomidine Treatment Regimens Pat. Sub. Date(s): All strengths: Feb 6, 2024 Claim Types: Method of use Use Code: U-3756: Acute treatment of agitation associated with bipolar I or II disorder by sublingual or buccal administration	Jul 17, 2040	New patent for this product

IMBRUVICA (CAPSULE) (ORAL) IBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PHARMACYCLICS LLC      NDA No.: 205552  Prod. No.: 001 RX (140MG); 002 RX (70MG)

Patents	Expiration	Change
Pat. No. 8754090 DLR* Use of inhibitors of bruton's tyrosine kinase (Btk) Pat. Sub. Date(s): 001: Jun 26, 2014; 002: Jan 19, 2018 Claim Types: Method of use Use Code: U-1456: Treatment of mantle cell lymphoma	Dec 3, 2031 *PED	New Delisting Request flag
Pat. No. 9814721 Use of inhibitors of Bruton'S tyrosine kinase (BTK) Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1947: Treatment of marginal zone lymphoma	Dec 3, 2031 *PED	This patent is no longer listed for this product
Pat. No. 10653696 Use of inhibitors of Bruton's tyrosine kinase (BTK) Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1456: Treatment of mantle cell lymphoma	Dec 3, 2031 *PED	This patent is no longer listed for this product

INBRIJA (POWDER) (INHALATION) LEVODOPA
Drug Classes: aromatic amino acid
NDA Applicant: ACORDA      NDA No.: 209184  Prod. No.: 001 RX (42MG)

Patents	Expiration	Change
Pat. No. 8404276 Pulmonary delivery for levodopa Pat. Sub. Date(s): None Claim Types: Method of use; Method of administration Use Code: U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles	Mar 19, 2023	This patent is no longer listed for this product
Pat. No. 8586093 Pulmonary delivery for levodopa Pat. Sub. Date(s): None Claim Types: Method of use; Method of administration Use Code: U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles	Mar 19, 2023	This patent is no longer listed for this product
Pat. No. 9155699 DP* Pulmonary delivery for levodopa Pat. Sub. Date(s): None Claim Types: Formulation	Mar 19, 2023	This patent is no longer listed for this product

INDOMETHACIN (SUSPENSION) (ORAL) INDOMETHACIN [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: NOVITIUM PHARMA      NDA No.: 217883  Prod. No.: 001 RX (25MG/5ML)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Jul 10, 2024	New product in Orange Book

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML)); 002 RX (500MG IRON/10ML (50MG IRON/ML)); 003 RX (1GM IRON/20ML (50MG IRON/ML))

Patents	Expiration	Change
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Pat. Sub. Date(s): 001: Sep 12, 2013; 002: Feb 2, 2021; 003: May 21, 2021 Claim Types: Formulation; Process	Feb 5, 2025	New expiration date. Was previously Feb 5, 2024
Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Compound; Composition	Oct 20, 2023	This patent is no longer listed for this product
Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Product-by-process; Composition; Formulation; Method of use Use Code: U-2555: A method of treating iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron Use Code: U-2557: A method of treating iron deficiency anemia in adult patients who have non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron Use Code: U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron Use Code: U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron	Oct 20, 2023	This patent is no longer listed for this product
Pat. No. 11291645 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Product-by-process; Composition; Formulation; Method of use Use Code: U-3351: Method of treating iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose Use Code: U-3352: Method to treat iron deficiency anemia in adults & pediatric patients 1 year and older with intolerance or unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose	Oct 20, 2023	This patent is no longer listed for this product
Pat. No. 11590097 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron Use Code: U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron	Oct 20, 2023	This patent is no longer listed for this product

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 004 RX (100MG IRON/2ML (50MG IRON/ML))

Patents	Expiration	Change
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Pat. Sub. Date(s): 004: Mar 4, 2022 Claim Types: Formulation; Process	Feb 5, 2025	New expiration date. Was previously Feb 5, 2024
Pat. No. 9376505 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Compound; Composition	Oct 20, 2023	This patent is no longer listed for this product
Pat. No. 11123321 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Product-by-process; Composition; Formulation; Method of use Use Code: U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron Use Code: U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron	Oct 20, 2023	This patent is no longer listed for this product
Pat. No. 11291645 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Product-by-process; Composition; Formulation; Method of use Use Code: U-3351: Method of treating iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease by intravenously administering ferric carboxymaltose Use Code: U-3352: Method to treat iron deficiency anemia in adults & pediatric patients 1 year and older with intolerance or unsatisfactory response to oral iron by intravenously administering ferric carboxymaltose	Oct 20, 2023	This patent is no longer listed for this product
Pat. No. 11590097 DS* DP* Aqueous iron carbohydrate complexes, their production and medicaments containing them Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-3312: Method to treat IDA in adults & pediatric patients 1 yr & older with intolerance or unsatisfactory response to oral iron & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 g of elemental iron Use Code: U-3313: Method of treating IDA in adult patients with non-dialysis dependent chronic kidney disease & weighing at least 40 kg by intravenously administering ferric carboxymaltose to provide at least about 0.6 grams of elemental iron	Oct 20, 2023	This patent is no longer listed for this product

INVELTYS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: corticosteroid
NDA Applicant: ALCON LABS INC      NDA No.: 210565  Prod. No.: 001 RX (1%)

Patents	Expiration	Change
Pat. No. 11872318 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus Pat. Sub. Date(s): 001: Feb 1, 2024 Claim Types: Formulation	May 3, 2033	New patent for this product

ISENTRESS (TABLET, CHEWABLE) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MSD SUB MERCK      NDA No.: 203045  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-257: Treatment of HIV infection	Apr 21, 2023 *PED	This patent is no longer listed for this product
Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-257: Treatment of HIV infection	Apr 21, 2023 *PED	This patent is no longer listed for this product

ISENTRESS (POWDER) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MSD SUB MERCK      NDA No.: 205786  Prod. No.: 001 RX (EQ 100MG BASE/PACKET)

Patents	Expiration	Change
Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-257: Treatment of HIV infection	Apr 21, 2023 *PED	This patent is no longer listed for this product
Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-257: Treatment of HIV infection	Apr 21, 2023 *PED	This patent is no longer listed for this product

ISENTRESS; ISENTRESS HD (TABLET) (ORAL) RALTEGRAVIR POTASSIUM
Drug Classes: human immunodeficiency virus type 1 integrase strand transfer inhibitor (HIV-1
NDA Applicant: MSD SUB MERCK      NDA No.: 022145  Prod. No.: 001 RX (EQ 400MG BASE); 002 RX (EQ 600MG BASE)

Patents	Expiration	Change
Pat. No. 7217713 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-257: Treatment of HIV infection	Apr 21, 2023 *PED	This patent is no longer listed for this product
Pat. No. 7435734 N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-257: Treatment of HIV infection Use Code: U-900: Integrase inhibition for the treatment of HIV infection	Apr 21, 2023 *PED	This patent is no longer listed for this product

JANUMET (TABLET) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MSD SUB MERCK      NDA No.: 022044  Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (1GM;EQ 50MG BASE)

Patents	Expiration	Change
Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Pat. Sub. Date(s): None Claim Types: Compound; Composition; Method of use Use Code: U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor	Jan 26, 2023 *PED	This patent is no longer listed for this product
Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin Use Code: U-1038: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin and a PPAR-gamma agonist Use Code: U-803: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin	Jan 26, 2023 *PED	This patent is no longer listed for this product

JANUMET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Drug Classes: biguanide == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MSD SUB MERCK      NDA No.: 202270  Prod. No.: 001 RX (500MG;EQ 50MG BASE); 002 RX (1GM;EQ 50MG BASE); 003 RX (1GM;EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Pat. Sub. Date(s): None Claim Types: Compound; Composition; Method of use Use Code: U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate	Jan 26, 2023 *PED	This patent is no longer listed for this product
Pat. No. 7125873 DP* Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1227: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin HCl extended release is appropriate	Jan 26, 2023 *PED	This patent is no longer listed for this product

JANUVIA (TABLET) (ORAL) SITAGLIPTIN PHOSPHATE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 021995  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 50MG BASE); 003 RX (EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. 6699871 DS* DP* Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Pat. Sub. Date(s): None Claim Types: Compound; Composition; Method of use Use Code: U-774: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor	Jan 26, 2023 *PED	This patent is no longer listed for this product
Pat. No. 7125873 Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1036: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with insulin Use Code: U-1037: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with a PPAR-gamma agonist Use Code: U-1038: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin and a PPAR-gamma agonist Use Code: U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea	Jan 26, 2023 *PED	This patent is no longer listed for this product

JENTADUETO (TABLET) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201281  Prod. No.: 001 RX (2.5MG;500MG); 002 RX (2.5MG;850MG); 003 RX (2.5MG;1GM)

Patents	Expiration	Change
Pat. No. 8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-802: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor	Aug 12, 2023	This patent is no longer listed for this product
Pat. No. 8178541 DP* 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-775: Method of treating Type 2 diabetes mellitus by administering a dipeptidyl peptidase-IV inhibitor in combination with metformin and/or a sulfonylurea	Aug 12, 2023	This patent is no longer listed for this product