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

ARNUITY ELLIPTA (POWDER) (INHALATION) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 205625  Prod. No.: 003 RX (0.05MG/INH)

Patents	Expiration	Change
Pat. No. 8113199 DP* Counter for use with a medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Apr 23, 2028 *PED	This patent is no longer listed for this product
Pat. No. 8161968 DP* Medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Aug 5, 2028 *PED	This patent is no longer listed for this product
Pat. No. 8534281 DP* Manifold for use in medicament dispenser Pat. Sub. Date(s): None Claim Types: Device	Sep 8, 2030 *PED	This patent is no longer listed for this product

ATORVALIQ (SUSPENSION) (ORAL) ATORVASTATIN CALCIUM
Drug Classes: HMG-CoA reductase inhibitor
NDA Applicant: CMP DEV LLC      NDA No.: 213260  Prod. No.: 001 RX (20MG/5ML)

Patents	Expiration	Change
Pat. No. 11925704 DP* Aqueous suspension suitable for oral administration Pat. Sub. Date(s): 001: Mar 25, 2024 Claim Types: Formulation; Method of use Use Code: U-3853: Method for lowering cholesterol level in a human	Jun 7, 2037	New patent for this product

AUGTYRO (CAPSULE) (ORAL) REPOTRECTINIB
Drug Classes: kinase inhibitor
NDA Applicant: BRISTOL      NDA No.: 218213  Prod. No.: 001 RX (40MG)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Nov 15, 2028	New exclusivity for this product

AURLUMYN (SOLUTION) (INTRAVENOUS) ILOPROST
Drug Classes: prostacycline
NDA Applicant: EICOS SCI      NDA No.: 217933  Prod. No.: 001 RX (100MCG/ML (100MCG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Feb 13, 2027	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-465: Treatment of severe frostbite in adults to reduce the risk of digit amputations	Feb 13, 2031	New exclusivity for this product

AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME      NDA No.: 215430  Prod. No.: 001 RX (105MG;45MG)

Patents	Expiration	Change
Pat. No. 11925636 Bupropion dosage forms with reduced food and alcohol dosing effects Pat. Sub. Date(s): 001: Mar 14, 2024 Claim Types: Method of use Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder	Jan 20, 2043	New patent for this product

AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor == cephalosporin antibacterial
NDA Applicant: ALLERGAN      NDA No.: 206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Jan 26, 2027	New expiration date. Was previously Dec 20, 2025

BIKTARVY (TABLET) (ORAL) BICTEGRAVIR SODIUM; 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.: 210251  Prod. No.: 001 RX (EQ 50MG BASE;200MG;EQ 25MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-468: Treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing at least 14 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir and with known or suspected substitutions associated with resistance to emtricitabine	Feb 23, 2031	New exclusivity for this product

BIKTARVY (TABLET) (ORAL) BICTEGRAVIR SODIUM; 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.: 210251  Prod. No.: 002 RX (EQ 30MG BASE;120MG;EQ 15MG BASE)

Patents	Expiration	Change
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)] Prodrugs of phosphonate nucleotide analogues Pat. Sub. Date(s): 002: Oct 28, 2021 Claim Types: Compound; Composition; Formulation	Oct 17, 2025 *PED	New expiration date. Was previously Apr 17, 2025
Pat. No. 8754065 DS* DP* Tenofovir alafenamide hemifumarate Pat. Sub. Date(s): 002: Oct 28, 2021 Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use; Process Use Code: U-257: Treatment of HIV infection	Feb 15, 2033 *PED	New expiration date. Was previously Aug 15, 2032
Pat. No. 9296769 DS* DP* Tenofovir alafenamide hemifumarate Pat. Sub. Date(s): 002: Oct 28, 2021 Claim Types: Formulation; Method of use Use Code: U-257: Treatment of HIV infection	Feb 15, 2033 *PED	New expiration date. Was previously Aug 15, 2032
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-468: Treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing at least 14 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir and with known or suspected substitutions associated with resistance to emtricitabine	Feb 23, 2031	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. 10570139 Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators Pat. Sub. Date(s): 001: Jun 4, 2021 Claim Types: Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3856: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy Use Code: U-3857: Treatment of adult patients with Waldenstrom's Macroglobulinemia (WM) Use Code: U-3858: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (mzl) who have received at least one prior anti-CD20-based regimen Use Code: U-3859: Treatment of adult patients with chronic lymphocytic leukemia (CLL) Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Apr 22, 2034	New Use Code
Pat. No. 11142528 DP* Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators Pat. Sub. Date(s): 001: Nov 12, 2021 Claim Types: Composition; Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3856: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy Use Code: U-3857: Treatment of adult patients with Waldenstrom's Macroglobulinemia (WM) Use Code: U-3858: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (mzl) who have received at least one prior anti-CD20-based regimen Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Apr 22, 2034	New Use Code
Pat. No. 11591340 (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: Mar 8, 2023 Claim Types: New polymorph, salt or hydrate; Process; Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3727: Treatment of adult patients with small lymphocytic lymphoma (SLL) who have received at least one prior therapy Use Code: U-3728: Treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy Use Code: U-3729: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (sll) who have received at least one prior therapy	Aug 15, 2037	New Use Code
Pat. No. 11701357 Treatment of B cell cancers using a combination comprising Btk inhibitors Pat. Sub. Date(s): 001: Apr 2, 2024 Claim Types: Method of use; Dosaage regimen Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Jun 24, 2039	New patent for this product
Pat. No. 11786531 Methods of treating B-cell proliferative disorder Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Jan 19, 2043	New Use Code
Pat. No. 11884674 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: Feb 28, 2024 Claim Types: Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Aug 15, 2037	New Use Code
Pat. No. 11896596 Methods of treating B-cell proliferative disorder Pat. Sub. Date(s): 001: Mar 12, 2024 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Jan 19, 2043	New patent for this product
Pat. No. 11911386 Methods Of Treating B-cell Proliferative Disorder Pat. Sub. Date(s): 001: Feb 28, 2024 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Jan 19, 2043	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-936: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Mar 7, 2027	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-467: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), after two or more lines of systemic therapy	Mar 7, 2031	New exclusivity for this product

CLOBETASOL PROPIONATE (SUSPENSION/DROPS) (OPHTHALMIC) CLOBETASOL PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: FORMOSA      NDA No.: 218158  Prod. No.: 001 RX (0.05%)

Patents	Expiration	Change
Pat. No. 10588913 DP* Aqueous suspension agent containing glucocorticosteroid nanoparticles Pat. Sub. Date(s): 001: Apr 1, 2024 Claim Types: Formulation; Process	May 9, 2036	New product in Orange Book
Pat. No. 11376262 DP* Method of treating an inflammatory or infectious disease Pat. Sub. Date(s): 001: Apr 1, 2024 Claim Types: Method of use Use Code: U-19: Treatment of inflammation	May 9, 2036	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Mar 4, 2027	New product in Orange Book

COMBOGESIC IV (SOLUTION) (INTRAVENOUS) ACETAMINOPHEN; IBUPROFEN SODIUM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HIKMA      NDA No.: 215320  Prod. No.: 001 RX (1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML))

Patents	Expiration	Change
Pat. No. 11896567 Combination composition Pat. Sub. Date(s): 001: Mar 12, 2024 Claim Types: Method of use Use Code: U-3744: Method of treating mild to moderate pain in adults Use Code: U-3745: Method of treating moderate to severe pain in adults as an adjunct to opioid analgesics	Oct 26, 2031	New patent for this product

DAURISMO (TABLET) (ORAL) GLASDEGIB MALEATE
Drug Classes: hedgehog pathway inhibitor
NDA Applicant: PFIZER      NDA No.: 210656  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. 11891372 Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate Pat. Sub. Date(s): All strengths: Mar 6, 2024 Claim Types: Method of use Use Code: U-3254: Use, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are >= 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy	Apr 13, 2036	New patent for this product

DAYVIGO (TABLET) (ORAL) LEMBOREXANT
Drug Classes: orexin receptor antagonist
NDA Applicant: EISAI INC      NDA No.: 212028  Prod. No.: 001 RX (5MG); 002 RX (10MG)

Patents	Expiration	Change
Pat. No. 10702529 DP* Compositions and methods for treating insomnia Pat. Sub. Date(s): All strengths: Mar 22, 2024 Claim Types: Formulation claimed by its inherent performace characteristics	Oct 21, 2035	New patent for this product
Pat. No. 11026944 DP* Compositions and methods for treating insomnia Pat. Sub. Date(s): All strengths: Mar 22, 2024 Claim Types: Formulation claimed by its inherent performace characteristics	Oct 21, 2035	New patent 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. 11925695 Methods for making ultrasound contrast agents Pat. Sub. Date(s): All strengths: Mar 22, 2024 Claim Types: Diagnostic or surgical method Use Code: U-665: Method of using the drug substance/drug product for ultrasound imaging	Mar 16, 2037	New patent for this product

EOHILIA (SUSPENSION) (ORAL) BUDESONIDE
Drug Classes: corticosteroid
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 213976  Prod. No.: 001 RX (2MG/10ML)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-466: Treatment of adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EOE)	Feb 9, 2031	New exclusivity for this product

EPRONTIA (SOLUTION) (ORAL) TOPIRAMATE
NDA Applicant: AZURITY      NDA No.: 214679  Prod. No.: 001 RX (25MG/ML)

Patents	Expiration	Change
Pat. No. 11911362 DP* Compositions and methods for treating epilepsy, seizures and other conditions Pat. Sub. Date(s): 001: Mar 12, 2024 Claim Types: Method of use; Formulation; Device Use Code: U-3413: Indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older Use Code: U-3414: Indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older Use Code: U-3415: Indicated for the preventive treatment of migraine in patients 12 years and older	Aug 21, 2040	New patent for this product

EXBLIFEP (POWDER) (INTRAVENOUS) CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
Drug Classes: cephalosporin antibacterial
NDA Applicant: ALLECRA THERAPS      NDA No.: 216165  Prod. No.: 001 RX (EQ 2GM BASE/VIAL;0.5GM/VIAL)

Patents	Expiration	Change
Pat. No. 7687488 DS* DP* 2-substituted methyl penam derivatives Pat. Sub. Date(s): 001: Mar 18, 2024 Claim Types: Compound; Process; Composition; Formulation; Method of use Use Code: U-3851: Use of EXBLIFEP (cefepime and enmetazobactam) for treating complicated urinary tract infections (CUTI) including pyelonephritis caused by designated susceptible microorganisms	Dec 3, 2027	New patent for this product
Pat. No. 11124526 Crystalline beta-lactamase inhibitor Pat. Sub. Date(s): 001: Mar 18, 2024 Claim Types: New polymorph, salt or hydrate; Process; Method of use Use Code: U-3852: Use of specified polymorphs of EXBLIFEP (cefepime and enmetazobactam) for treating complicated urinary tract infections (CUTI) including pyelonephritis caused by designated susceptible microorganisms	Nov 7, 2034	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Feb 22, 2034 GAIN	New exclusivity 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))

Patents	Expiration	Change
Pat. No. 11918565 Treatment of post-operative pain via sciatic nerve block with sustained-release liposomal anesthetic compositions Pat. Sub. Date(s): All strengths: Mar 20, 2024 Claim Types: Method of administration Use Code: U-3841: A method of administering bupivacaine to produce regional analgesia via sciatic nerve block in the popliteal fossa in adults	Feb 2, 2043	New patent for this product
Pat. No. 11925706 DP* Manufacturing of bupivacaine multivesicular liposomes Pat. Sub. Date(s): All strengths: Mar 15, 2024 Claim Types: Formulation Use Code: U-3380: Method of treating pain, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia	Jan 22, 2041	New patent for this product
Pat. No. 11931459 Treatment of pain in pediatric patients by administration of sustained-release liposomal anesthetic compositions Pat. Sub. Date(s): All strengths: Mar 20, 2024 Claim Types: Method of use Use Code: U-3839: A method of treating pain by administering bupivacaine via local infiltration in pediatric patients aged 6 to less than 12 years old undergoing cardiac surgery Use Code: U-3840: A method of treating pain by administering bupivacaine via local infiltration in pediatric patients aged 6 to less than 17 years old undergoing spine surgery	Mar 17, 2042	New patent for this product

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 202293  Prod. No.: 001 RX (5MG)

Patents	Expiration	Change
Pat. No. 7456254 Polymer-based sustained release device Pat. Sub. Date(s): 001: Nov 15, 2017 Claim Types: Formulation; Method of use Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide	Jun 30, 2025
Pat. No. 8431685 Polymer-based sustained release device Pat. Sub. Date(s): 001: Nov 15, 2017 Claim Types: Formulation; Method of use Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide	Apr 13, 2025
Pat. No. 8461105 Polymer-based sustained release device Pat. Sub. Date(s): 001: Nov 15, 2017 Claim Types: Formulation; Method of use Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide	Apr 13, 2025
Pat. No. 9238076 Polymer-based sustained release device Pat. Sub. Date(s): 001: Nov 15, 2017 Claim Types: Formulation; Method of use Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide	Apr 15, 2024

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 202293  Prod. No.: 002 RX (10MG)

Patents	Expiration	Change
Pat. No. 7456254 Polymer-based sustained release device Pat. Sub. Date(s): 002: Nov 15, 2017 Claim Types: Formulation; Method of use Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide	Jun 30, 2025
Pat. No. 8431685 Polymer-based sustained release device Pat. Sub. Date(s): 002: Nov 15, 2017 Claim Types: Formulation; Method of use Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide	Apr 13, 2025
Pat. No. 8461105 Polymer-based sustained release device Pat. Sub. Date(s): 002: Nov 15, 2017 Claim Types: Formulation; Method of use Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide	Apr 13, 2025
Pat. No. 9238076 Polymer-based sustained release device Pat. Sub. Date(s): 002: Nov 15, 2017 Claim Types: Formulation; Method of use Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide	Apr 15, 2024
Pat. No. 11903955 Methods of treating heart failure with reduced ejection fraction Pat. Sub. Date(s): 002: Mar 13, 2024 Claim Types: Method of use Use Code: U-3825: Reduce the risk of cardiovascular death and worsening heart failure in adults with heart failure with reduced ejection fraction, without type ii diabetes, and having an HBA1C of < 5.7%	Mar 9, 2040	New patent for this product

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

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Dec 18, 2028	New exclusivity 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. 7500444 DP* DLR* Actuation indicator for a dispensing device Pat. Sub. Date(s): All strengths: None Claim Types: Device	Aug 26, 2026 *PED	New Delisting Request flag

FORTEO (SOLUTION) (SUBCUTANEOUS) TERIPARATIDE [GENERIC AP]
Drug Classes: parathyroid hormone analog
NDA Applicant: LILLY      NDA No.: 021318  Prod. No.: 002 RX (0.6MG/2.4ML (0.25MG/ML))

Patents	Expiration	Change
Pat. No. 7517334 DP* Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose Pat. Sub. Date(s): None Claim Types: Device	Mar 25, 2025	This patent is no longer listed for this product

FYCOMPA (TABLET) (ORAL) PERAMPANEL
Drug Classes: non-competitive AMPA glutamate receptor antagonist
NDA Applicant: CATALYST PHARMS      NDA No.: 202834  Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (6MG); 004 RX (8MG); 005 RX (10MG); 006 RX (12MG)

Patents	Expiration	Change
Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof Pat. Sub. Date(s): All strengths: Nov 19, 2012 Claim Types: Compound; Composition; Method of use Use Code: U-106: Treatment of epilepsy Use Code: U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy Use Code: U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy Use Code: U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Use Code: U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older	May 23, 2025	New expiration date. Was previously Jun 8, 2024

FYCOMPA (SUSPENSION) (ORAL) PERAMPANEL
Drug Classes: non-competitive AMPA glutamate receptor antagonist
NDA Applicant: CATALYST PHARMS      NDA No.: 208277  Prod. No.: 001 RX (0.5MG/ML)

Patents	Expiration	Change
Pat. No. 6949571 DS* DP* 1,2-dihydropyridine compounds, process for preparation of the same and use thereof Pat. Sub. Date(s): 001: May 27, 2016 Claim Types: Compound; Composition; Method of use Use Code: U-106: Treatment of epilepsy Use Code: U-2088: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy Use Code: U-2089: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy Use Code: U-2428: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older Use Code: U-2429: Treatment of primary generalized tonic-clonic seizures as adjunctive therapy in patients with epilepsy 12 years of age and older	May 23, 2025	New expiration date. Was previously Jun 8, 2024

GOCOVRI (CAPSULE, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: ADAMAS OPERATIONS      NDA No.: 208944  Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)

Patents	Expiration	Change
Pat. No. 11903908 Methods of administering amantadine Pat. Sub. Date(s): All strengths: Mar 8, 2024 Claim Types: Method of use Use Code: U-3822: As adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing 'off' episodes	Dec 4, 2034	New patent for this product

HETLIOZ (CAPSULE) (ORAL) TASIMELTEON [GENERIC AB]
Drug Classes: melatonin receptor agonist
NDA Applicant: VANDA PHARMS INC      NDA No.: 205677  Prod. No.: 001 RX (20MG)

Patents	Expiration	Change
Pat. No. 11826339 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Apr 4, 2024 Claim Types: Method of use Use Code: U-3342: Treatment of nighttime sleep disturbances in smith-magenis syndrome by avoiding the administration of tasimelteon with beta-adrenergic receptor antagonists Use Code: U-3343: Treatment of non-24-hour sleep-wake disorder by avoiding the administration of tasimelteon with beta-adrenergic receptor antagonists	Jan 25, 2033	New patent for this product
Pat. No. 11918556 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Apr 4, 2024 Claim Types: Method of use Use Code: U-3342: Treatment of nighttime sleep disturbances in smith-magenis syndrome by avoiding the administration of tasimelteon with beta-adrenergic receptor antagonists Use Code: U-3343: Treatment of non-24-hour sleep-wake disorder by avoiding the administration of tasimelteon with beta-adrenergic receptor antagonists	Jan 25, 2033	New patent for this product
Pat. No. 11918557 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Apr 4, 2024 Claim Types: Method of use Use Code: U-3003: Treatment of nighttime sleep disturbances in Smith-Magenis syndrome by administering tasimelteon Use Code: U-3865: Treatment of non-24-hour sleep-wake disorder by administering tasimelteon	Apr 7, 2033	New patent for this product

HETLIOZ LQ (SUSPENSION) (ORAL) TASIMELTEON
Drug Classes: melatonin receptor agonist
NDA Applicant: VANDA PHARMS INC      NDA No.: 214517  Prod. No.: 001 RX (4MG/ML)

Patents	Expiration	Change
Pat. No. 11826339 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Apr 4, 2024 Claim Types: Method of use Use Code: U-3342: Treatment of nighttime sleep disturbances in smith-magenis syndrome by avoiding the administration of tasimelteon with beta-adrenergic receptor antagonists	Jan 25, 2033	New patent for this product
Pat. No. 11918556 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Apr 4, 2024 Claim Types: Method of use Use Code: U-3342: Treatment of nighttime sleep disturbances in smith-magenis syndrome by avoiding the administration of tasimelteon with beta-adrenergic receptor antagonists	Jan 25, 2033	New patent for this product
Pat. No. 11918557 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Apr 4, 2024 Claim Types: Method of use Use Code: U-3003: Treatment of nighttime sleep disturbances in Smith-Magenis syndrome by administering tasimelteon	Apr 7, 2033	New patent for this product

ICLUSIG (TABLET) (ORAL) PONATINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 203469  Prod. No.: 001 RX (EQ 15MG BASE); 002 RX (EQ 45MG BASE); 003 RX (EQ 30MG BASE); 004 RX (EQ 10MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-934: Treatment of adult patients with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia (PH+ ALL) in combination with chemotherapy	Mar 19, 2027	New exclusivity for this product

IMBRUVICA (SUSPENSION) (ORAL) IBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PHARMACYCLICS LLC      NDA No.: 217003  Prod. No.: 001 RX (70MG/ML)

Patents	Expiration	Change
Pat. No. 8476284 Inhibitors of Bruton's tyrosine kinase Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) Use Code: U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion Use Code: U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM)	Dec 28, 2026	New patent for this product
Pat. No. 8497277 Inhibitors of Bruton's tyrosine kinase Pat. Sub. Date(s): 001: Sep 21, 2022 Claim Types: Method of use Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy Use Code: U-3422: Treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy Use Code: U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion Use Code: U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) Use Code: U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion Use Code: U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM)	Jun 28, 2027 *PED	New Use Code
Pat. No. 8563563 Inhibitors of bruton's tyrosine kinase Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion Use Code: U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) Use Code: U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion Use Code: U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM)	Apr 26, 2027	New patent for this product
Pat. No. 8703780 Inhibitors of Bruton's tyrosine kinase Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion	Dec 28, 2026	New patent for this product
Pat. No. 8952015 Inhibitors of Bruton's tyrosine kinase Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion Use Code: U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) Use Code: U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion Use Code: U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM)	Dec 28, 2026	New patent for this product
Pat. No. 8999999 Use of inhibitors of Bruton's tyrosine kinase (Btk) Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion Use Code: U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) Use Code: U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion	Jun 3, 2031	New patent for this product
Pat. No. 9125889 Use of inhibitors of Bruton's tyrosine kinase (Btk) Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM)	Jun 3, 2031	New patent for this product
Pat. No. 9795604 Methods of treating and preventing graft versus host disease Pat. Sub. Date(s): 001: Sep 21, 2022 Claim Types: Method of use Use Code: U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy Use Code: U-3422: Treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy	Apr 24, 2035 *PED	New Use Code
Pat. No. 9801881 Use of inhibitors of bruton's tyrosine kinase (BTK) Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-3846: Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia Use Code: U-3847: Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion	Jun 3, 2031	New patent for this product
Pat. No. 9801883 Use of inhibitors of bruton's tyrosine kinase (BTK) Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion Use Code: U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) Use Code: U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion	Jun 3, 2031	New patent for this product
Pat. No. 10004746 Use of inhibitors of Bruton's tyrosine kinase (BTK) Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-3846: Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia Use Code: U-3847: Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion Use Code: U-3848: Treatment of adult patients with relapsed or refractory small lymphocytic lymphoma (SLL) with 17p deletion Use Code: U-3849: Treatment of adult patients with relapsed or refractory small lymphocytic lymphoma (SLL)	Jun 3, 2031	New patent for this product
Pat. No. 10016435 Use of inhibitors of Bruton's tyrosine kinase (BTK) Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM)	Jun 3, 2031	New patent for this product
Pat. No. 10463668 Methods of treating and preventing graft versus host disease Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy	Oct 24, 2034	New patent for this product
Pat. No. 10478439 Use of inhibitors of bruton's tyrosine kinase (Btk) Pat. Sub. Date(s): 001: Sep 21, 2022 Claim Types: Method of use Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy Use Code: U-3422: Treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy Use Code: U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion Use Code: U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) Use Code: U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion Use Code: U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM)	Dec 3, 2031 *PED	New Use Code
Pat. No. 10695350 Methods of treating and preventing graft versus host disease Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy	Oct 24, 2034	New patent for this product
Pat. No. 10751342 Use of inhibitors of Bruton's tyrosine kinase (Btk) Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion Use Code: U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) Use Code: U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion	Jun 3, 2031	New patent for this product
Pat. No. 11672803 Use of inhibitors of Brutons tyrosine kinase (Btk) Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion Use Code: U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) Use Code: U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion	Jun 3, 2031	New patent for this product

IWILFIN (TABLET) (ORAL) EFLORNITHINE HYDROCHLORIDE
Drug Classes: antiprotozoal == decarboxylase inhibitor
NDA Applicant: USWM      NDA No.: 215500  Prod. No.: 001 RX (EQ 192MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Dec 13, 2026	New exclusivity 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. 11911388 Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral or non-oral antidiabetic drug Pat. Sub. Date(s): All strengths: Mar 25, 2024 Claim Types: Method of use Use Code: U-3854: Linagliptin (5 mg daily dose) and metformin (with or without insulin) for treating type 2 diabetes patients with renal impairment and insufficient glycemic control despite previous treatment with metformin alone or in combination with insulin	Apr 10, 2030	New patent for this product

JENTADUETO XR (TABLET, EXTENDED RELEASE) (ORAL) LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 208026  Prod. No.: 001 RX (2.5MG;1GM); 002 RX (5MG;1GM)

Patents	Expiration	Change
Pat. No. 11911388 Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral or non-oral antidiabetic drug Pat. Sub. Date(s): All strengths: Mar 25, 2024 Claim Types: Method of use Use Code: U-3854: Linagliptin (5 mg daily dose) and metformin (with or without insulin) for treating type 2 diabetes patients with renal impairment and insufficient glycemic control despite previous treatment with metformin alone or in combination with insulin	Apr 10, 2030	New patent for this product

JORNAY PM (CAPSULE, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [Has competitive generic]
Drug Classes: central nervous system stimulant
NDA Applicant: IRONSHORE PHARMS      NDA No.: 209311  Prod. No.: 001 RX (20MG); 002 RX (40MG); 003 RX (60MG); 004 RX (80MG); 005 RX (100MG)

Patents	Expiration	Change
Pat. No. 11911518 Compositions for treatment of attention deficit hyperactivity disorder Pat. Sub. Date(s): All strengths: Mar 20, 2024 Claim Types: Method of use Use Code: U-2357: Method of treating attention deficit hyperactivity disorder (ADHD)	Mar 23, 2032	New patent for this product

KATERZIA (SUSPENSION) (ORAL) AMLODIPINE BENZOATE
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: AZURITY      NDA No.: 211340  Prod. No.: 001 RX (EQ 1MG BASE/ML)

Patents	Expiration	Change
Pat. No. 11918685 Amlodipine formulations Pat. Sub. Date(s): 001: Mar 14, 2024 Claim Types: Method of use Use Code: U-3447: A method of treating coronary artery disease Use Code: U-3448: A method of treating hypertension	Oct 6, 2037	New patent for this product

KONVOMEP (FOR SUSPENSION) (ORAL) OMEPRAZOLE; SODIUM BICARBONATE
Drug Classes: proton pump inhibitor
NDA Applicant: AZURITY      NDA No.: 213593  Prod. No.: 001 RX (2MG/ML;84MG/ML)

Patents	Expiration	Change
Pat. No. 11911473 Compositions and kits for omeprazole suspension Pat. Sub. Date(s): 001: Mar 14, 2024 Claim Types: Method of use Use Code: U-623: Short term treatment of active benign gastric ulcer Use Code: U-624: Reduction of risk of upper gastrointestinal bleeding in critically ill patients	Jul 16, 2039	New patent for this product

LENVIMA (CAPSULE) (ORAL) LENVATINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: EISAI INC      NDA No.: 206947  Prod. No.: 001 RX (EQ 4MG BASE); 002 RX (EQ 10MG BASE)

Patents	Expiration	Change
Pat. No. 7253286 DS* DP* [Extended 1466 days (4 years)] Nitrogen-containing aromatic derivatives Pat. Sub. Date(s): All strengths: Mar 10, 2015 Claim Types: Compound; Composition	Apr 24, 2026 *PED	New expiration date. Was previously Oct 24, 2025
Pat. No. 7612208 DS* DP* Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6- Pat. Sub. Date(s): All strengths: Mar 10, 2015 Claim Types: New polymorph, salt or hydrate; Process; Composition	Mar 19, 2027 *PED	New expiration date. Was previously Sep 19, 2026
Pat. No. 9006256 Antitumor agent for thyroid cancer Pat. Sub. Date(s): All strengths: May 12, 2015 Claim Types: Method of use Use Code: U-1695: Method for treating thyroid carcinoma including differentiated thyroid cancer	Jan 27, 2028 *PED	New expiration date. Was previously Jul 27, 2027
Pat. No. 10259791 DS* High-purity quinoline derivative and method for manufacturing same Pat. Sub. Date(s): All strengths: May 13, 2019 Claim Types: Impurity content limitation; Process	Feb 26, 2036 *PED	New expiration date. Was previously Aug 26, 2035
Pat. No. 10407393 DS* High-purity quinoline derivative and method for manufacturing same Pat. Sub. Date(s): All strengths: Oct 4, 2019 Claim Types: New polymorph, salt or hydrate with purity limitation	Feb 26, 2036 *PED	New expiration date. Was previously Aug 26, 2035
Pat. No. 11090386 Method for suppressing bitterness of quinoline derivative Pat. Sub. Date(s): All strengths: Feb 10, 2023 Claim Types: Method of administration Use Code: U-3519: Treatment with LENVIMA by administering LENVIMA as a suspension	Aug 23, 2036 *PED	New expiration date. Was previously Feb 23, 2036
Pat. No. 11186547 DS* High-purity quinoline derivative and method for manufacturing same Pat. Sub. Date(s): All strengths: Dec 17, 2021 Claim Types: Compound	Feb 26, 2036 *PED	New expiration date. Was previously Aug 26, 2035
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-196: Indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)	Feb 15, 2026 PED	New expiration date. Was previously Aug 15, 2025

LIVMARLI (SOLUTION) (ORAL) MARALIXIBAT CHLORIDE
Drug Classes: ileal bile acid transporter (IBAT) inhibitor
NDA Applicant: MIRUM      NDA No.: 214662  Prod. No.: 001 RX (EQ 9.5MG BASE/ML)

Patents	Expiration	Change
Pat. No. 10512657 Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases Pat. Sub. Date(s): 001: Mar 22, 2024 Claim Types: Method of use Use Code: U-3850: Treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestatis (PFIC)	Oct 26, 2032	New patent for this product
Pat. No. 11229661 Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases Pat. Sub. Date(s): 001: Mar 22, 2024 Claim Types: Method of use Use Code: U-3850: Treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestatis (PFIC)	Oct 26, 2032	New patent for this product
Pat. No. 11918578 Methods for treating cholestasis Pat. Sub. Date(s): 001: Mar 22, 2024 Claim Types: Method of use Use Code: U-3290: Treatment of cholestatic pruritus in patients with alagille syndrome (ALGS)	Feb 12, 2040	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-938: Treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC)	Mar 13, 2027	New exclusivity for this product

LODOCO (TABLET) (ORAL) COLCHICINE
Drug Classes: alkaloid
NDA Applicant: AGEPHA PHARMA FZ      NDA No.: 215727  Prod. No.: 001 RX (0.5MG)

Patents	Expiration	Change
Pat. No. 11944594 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Pat. Sub. Date(s): 001: Apr 3, 2024 Claim Types: Method of improving a treatment Use Code: U-3864: Method for reducing a risk of at least one cardiovascular event	Nov 1, 2033	New patent for this product
Pat. No. 11944595 Treatment or prevention of cardiovascular events via the administration of a colchicine derivative Pat. Sub. Date(s): 001: Apr 5, 2024 Claim Types: Method of improving a treatment Use Code: U-3867: Method for reducing a composite endpoint risk of myocardial infarction (MI), stroke, coronary revascularization, unstable angina requiring hospitalization, cardiac arrest, and cardiovascular death Use Code: U-3868: Method for reducing acute myocardial infarction risk	Nov 1, 2033	New patent for this product

LUTATHERA (SOLUTION) (INTRAVENOUS) LUTETIUM LU 177 DOTATATE
NDA Applicant: AAA USA INC      NDA No.: 208700  Prod. No.: 001 RX (10mCi/ML)

Patents	Expiration	Change
Pat. No. 11904027 DP* Stable, concentrated radionuclide complex solutions Pat. Sub. Date(s): 001: Mar 15, 2024 Claim Types: Process; Product-by-process	Jul 25, 2038	New patent for this product

LYVISPAH (GRANULES) (ORAL) BACLOFEN
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: AMNEAL      NDA No.: 215422  Prod. No.: 001 RX (5MG/PACKET); 002 RX (10MG/PACKET); 003 RX (20MG/PACKET)

Patents	Expiration	Change
Pat. No. 11931328 DP* Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Pat. Sub. Date(s): All strengths: Apr 2, 2024 Claim Types: Formulation	Jul 29, 2039	New patent for this product

METAXALONE (TABLET) (ORAL) METAXALONE
Drug Classes: muscle relaxant
NDA Applicant: PRIMUS PHARMS      NDA No.: 022503  Prod. No.: 001 DISC (640MG**)

Patents	Expiration	Change
Pat. No. 11918559 DP* Reduced dose metaxalone formulations Pat. Sub. Date(s): 001: Mar 13, 2024 Claim Types: Formulation	Jul 29, 2039	New patent for this product

MINOCIN (INJECTABLE) (INJECTION) MINOCYCLINE HYDROCHLORIDE
Drug Classes: tetracycline class drug
NDA Applicant: REMPEX      NDA No.: 050444  Prod. No.: 001 RX (EQ 100MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 11944634 DP* Tetracycline compositions Pat. Sub. Date(s): 001: Apr 2, 2024 Claim Types: Formulation	Oct 16, 2032	New patent for this product

NEXLETOL (TABLET) (ORAL) BEMPEDOIC ACID
NDA Applicant: ESPERION THERAPS INC      NDA No.: 211616  Prod. No.: 001 RX (180MG)

Patents	Expiration	Change
Pat. No. 11926584 Methods of making bempedoic acid and compositions of the same Pat. Sub. Date(s): 001: Apr 9, 2024 Claim Types: Method of use Use Code: U-3873: A method of lowering low-density lipoprotein cholesterol (LDL-C) in a human patient in need thereof comprising administration of bempedoic acid alone or in combination with other lipid lowering therapies	Jun 19, 2040	New patent for this product

NEXLIZET (TABLET) (ORAL) BEMPEDOIC ACID; EZETIMIBE
Drug Classes: dietary cholesterol absorption inhibitor
NDA Applicant: ESPERION THERAPS INC      NDA No.: 211617  Prod. No.: 001 RX (180MG;10MG)

Patents	Expiration	Change
Pat. No. 11926584 Methods of making bempedoic acid and compositions of the same Pat. Sub. Date(s): 001: Apr 9, 2024 Claim Types: Method of use Use Code: U-3873: A method of lowering low-density lipoprotein cholesterol (LDL-C) in a human patient in need thereof comprising administration of bempedoic acid alone or in combination with other lipid lowering therapies	Jun 19, 2040	New patent for this product

OGSIVEO (TABLET) (ORAL) NIROGACESTAT HYDROBROMIDE
NDA Applicant: SPRINGWORKS      NDA No.: 217677  Prod. No.: 001 RX (EQ 50MG BASE)

Patents	Expiration	Change
Pat. No. 11925619 Treatments with nirogacestat Pat. Sub. Date(s): 001: Mar 14, 2024 Claim Types: Dosaage regimen; Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New patent for this product
Pat. No. 11925620 Treatments with nirogacestat Pat. Sub. Date(s): 001: Mar 14, 2024 Claim Types: Method of use Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New patent for this product
Pat. No. 11938116 Treatments with nirogacestat Pat. Sub. Date(s): 001: Mar 27, 2024 Claim Types: Dosaage regimen Use Code: U-3754: Treatment of adult patients with progressing desmoid tumors	May 19, 2043	New patent for this product

OLINVYK (SOLUTION) (INTRAVENOUS) OLICERIDINE
NDA Applicant: TREVENA      NDA No.: 210730  Prod. No.: 001 RX (1MG/ML (1MG/ML)); 002 RX (2MG/2ML (1MG/ML)); 003 RX (30MG/30ML (1MG/ML))

Patents	Expiration	Change
Pat. No. 11931350 DS* Opioid receptor ligands and methods of using and making same Pat. Sub. Date(s): All strengths: Apr 9, 2024 Claim Types: Compound; Method of use Use Code: U-2986: Management of acute pain by intravenous injection	Mar 23, 2032	New patent for this product

ONGENTYS (CAPSULE) (ORAL) OPICAPONE
Drug Classes: catechol-O-methyltransferase (COMT) inhibitor
NDA Applicant: NEUROCRINE      NDA No.: 212489  Prod. No.: 001 RX (25MG); 002 RX (50MG)

Patents	Expiration	Change
Pat. No. 8168793 DS* DP* Nitrocatechol derivatives as COMT inhibitors Pat. Sub. Date(s): All strengths: May 19, 2020 Claim Types: Compound; Method of use; Composition Use Code: U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes	Apr 2, 2029	New Use Code
Pat. No. 8524746 Dosage regimen for COMT inhibitors Pat. Sub. Date(s): All strengths: May 19, 2020 Claim Types: Method of use Use Code: U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes	Jul 14, 2029	New Use Code
Pat. No. 9550759 Nitrocatechol derivatives as COMT inhibitors Pat. Sub. Date(s): All strengths: May 19, 2020 Claim Types: Method of improving a treatment; Method of use; Process Use Code: U-3870: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by increasing l-dopa amounts that reach the brain Use Code: U-3871: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by inhibiting comt in the periphery Use Code: U-3872: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by reducing o-methylation of l-dopa	Jul 26, 2026	New Use Code
Pat. No. 9630955 DS* DP* Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor Pat. Sub. Date(s): All strengths: May 19, 2020 Claim Types: New polymorph, salt or hydrate; Product-by-process; Formulation; Method of use Use Code: U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes	Dec 12, 2032	New Use Code
Pat. No. 9745290 DP* Dosage regimen for COMT inhibitors Pat. Sub. Date(s): All strengths: May 19, 2020 Claim Types: Composition; Formulation; Method of use; Kit Use Code: U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes	Oct 10, 2027	New Use Code
Pat. No. 10357468 DLR* Medicaments for slowing Parkinson's disease Pat. Sub. Date(s): All strengths: May 19, 2020 Claim Types: Method of use Use Code: U-2812: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease	May 27, 2035	New Delisting Request flag
Pat. No. 10583130 Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof Pat. Sub. Date(s): All strengths: May 19, 2020 Claim Types: Method of use Use Code: U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes	Mar 31, 2030	New Use Code

ONIVYDE (INJECTABLE, LIPOSOMAL) (INTRAVENOUS) IRINOTECAN HYDROCHLORIDE
Drug Classes: topoisomerase inhibitor
NDA Applicant: IPSEN      NDA No.: 207793  Prod. No.: 001 RX (EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML))

Patents	Expiration	Change
Pat. No. 11344552 Methods for treating metastatic pancreatic cancer using combination therapies comprising liposomal irinotecan and oxaliplatin Pat. Sub. Date(s): 001: Mar 12, 2024 Claim Types: Method of use; Dosaage regimen; Formulation Use Code: U-3824: Treatment of metastatic pancreatic adenocarcinoma in combination with oxaliplatin, fluorouracil, and leucovorin	Aug 19, 2036	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-932: In combination with oxaliplatin, fluorouracil and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma	Feb 13, 2027	New exclusivity for this product

PIQRAY (TABLET) (ORAL) ALPELISIB
NDA Applicant: NOVARTIS      NDA No.: 212526  Prod. No.: 001 RX (50MG); 002 RX (150MG); 003 RX (200MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-937: Expansion of the indication to include pre and perimenopausal women	Jan 18, 2027	New exclusivity for this product

PREVDUO (SOLUTION) (INTRAVENOUS) GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE
Drug Classes: anticholinergic == antimuscarinic agent == cholinesterase inhibitor
NDA Applicant: AZURITY      NDA No.: 216903  Prod. No.: 001 RX (0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML))

Patents	Expiration	Change
Pat. No. 11938217 DP* Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate Pat. Sub. Date(s): 001: Mar 28, 2024 Claim Types: Formulation; Drug in a container	Oct 25, 2038	New patent for this product

QINLOCK (TABLET) (ORAL) RIPRETINIB
Drug Classes: kinase inhibitor
NDA Applicant: DECIPHERA PHARMS      NDA No.: 213973  Prod. No.: 001 RX (50MG)

Patents	Expiration	Change
Pat. No. 11911370 DP* Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea Pat. Sub. Date(s): 001: Mar 13, 2024 Claim Types: Formulation	Dec 30, 2040	New patent for this product
Pat. No. 11918564 DP* Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea Pat. Sub. Date(s): 001: Mar 13, 2024 Claim Types: Formulation	Dec 30, 2040	New patent for this product

QVAR REDIHALER (AEROSOL, METERED) (INHALATION) BECLOMETHASONE DIPROPIONATE
Drug Classes: corticosteroid
NDA Applicant: NORTON WATERFORD      NDA No.: 207921  Prod. No.: 001 RX (0.04MG/INH); 002 RX (0.08MG/INH)

Patents	Expiration	Change
Pat. No. 11896759 DP* Inhalers and related methods Pat. Sub. Date(s): All strengths: Mar 11, 2024 Claim Types: Device	Jan 26, 2038	New patent for this product

RADICAVA ORS (SUSPENSION) (ORAL) EDARAVONE
NDA Applicant: MITSUBISHI TANABE      NDA No.: 215446  Prod. No.: 001 RX (105MG/5ML)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-144: Treatment of amyotrophic lateral sclerosis (ALS)	May 12, 2029	New exclusivity for this product

RECORLEV (TABLET) (ORAL) LEVOKETOCONAZOLE
Drug Classes: cortisol synthesis inhibitor
NDA Applicant: STRONGBRIDGE      NDA No.: 214133  Prod. No.: 001 RX (150MG)

Patents	Expiration	Change
Pat. No. 11903940 Methods of treating disease with levoketoconazole Pat. Sub. Date(s): 001: Mar 8, 2024 Claim Types: Method of use Use Code: U-3821: During levoketoconazole dosage titration for the treatment of Cushing's Syndrome in patients who concomitantly use an OCT2 substrate, monitoring the subject for a dose limiting event and adjusting the dosage of the OCT2 substrate as needed	Mar 2, 2040	New patent for this product

REVATIO (TABLET) (ORAL) SILDENAFIL CITRATE [GENERIC AB]
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: VIATRIS      NDA No.: 021845  Prod. No.: 001 RX (EQ 20MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-469: Treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in pediatric patients 1 to 17 years old to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise	Jan 31, 2030	New exclusivity for this product

REZDIFFRA (TABLET) (ORAL) RESMETIROM
NDA Applicant: MADRIGAL      NDA No.: 217785  Prod. No.: 001 RX (60MG); 002 RX (80MG); 003 RX (100MG)

Patents	Expiration	Change
Pat. No. 7452882 DS* DP* Thyroid hormone analogs Pat. Sub. Date(s): All strengths: Apr 3, 2024 Claim Types: Compound; Composition	Sep 12, 2026	New product in Orange Book
Pat. No. 9266861 DS* DP* Method of synthesizing thyroid hormone analogs and polymorphs thereof Pat. Sub. Date(s): All strengths: Apr 3, 2024 Claim Types: New polymorph, salt or hydrate; Composition; Process	Sep 17, 2033	New product in Orange Book
Pat. No. 10376517 Methods of synthesizing thyroid hormone analogs and polymorphs thereof Pat. Sub. Date(s): All strengths: Apr 3, 2024 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-3861: Treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis)	Sep 17, 2033	New product in Orange Book
Pat. No. 11564926 DS* DP* Methods of synthesizing thyroid hormone analogs and polymorphs thereof Pat. Sub. Date(s): All strengths: Apr 3, 2024 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-3861: Treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis)	Sep 17, 2033	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Mar 14, 2029	New product in Orange Book

RUKOBIA (TABLET, EXTENDED RELEASE) (ORAL) FOSTEMSAVIR TROMETHAMINE
NDA Applicant: VIIV HLTHCARE      NDA No.: 212950  Prod. No.: 001 RX (EQ 600MG BASE)

Patents	Expiration	Change
Pat. No. 8168615 DP* Prodrugs of piperazine and substituted piperidine antiviral agents Pat. Sub. Date(s): 001: Jul 17, 2020 Claim Types: Composition	Jul 13, 2029	New expiration date. Was previously Feb 25, 2025

SKYCLARYS (CAPSULE) (ORAL) OMAVELOXOLONE
NDA Applicant: REATA PHARMS      NDA No.: 216718  Prod. No.: 001 RX (50MG)

Patents	Expiration	Change
Pat. No. 11919838 Antioxidant inflammation modulators: oleanolic acid derivatives with amino and other modifications at C-17 Pat. Sub. Date(s): 001: Apr 3, 2024 Claim Types: Method of use Use Code: U-3862: Method of treating Friedrich's ataxia by activating the NRF2 pathway Use Code: U-3863: Method of treating Friedrich's ataxia by activating the NRF2 pathway which reduces oxidative stress	Apr 20, 2029	New patent for this product

SPINRAZA (SOLUTION) (INTRATHECAL) NUSINERSEN SODIUM
Drug Classes: survival motor neuron-2 (SMN2)-directed antisense oligonucleotide
NDA Applicant: BIOGEN IDEC      NDA No.: 209531  Prod. No.: 001 RX (EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML))

Patents	Expiration	Change
Pat. No. 8361977 DS* DP* Compositions and methods for modulation of SMN2 splicing Pat. Sub. Date(s): 001: Jan 23, 2017 Claim Types: Compound; Composition	Dec 23, 2030	New expiration date. Was previously May 27, 2030

SYFOVRE (SOLUTION) (INTRAVITREAL) PEGCETACOPLAN
Drug Classes: complement inhibitor
NDA Applicant: APELLIS PHARMS      NDA No.: 217171  Prod. No.: 001 RX (15MG/0.1ML (15MG/0.1ML))

Patents	Expiration	Change
Pat. No. 11903994 Dosing regimens Pat. Sub. Date(s): 001: Mar 18, 2024 Claim Types: Method of use; Dosaage regimen Use Code: U-3826: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan every other month Use Code: U-3827: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan monthly Use Code: U-3828: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan monthly or every other month	Feb 22, 2037	New patent for this product

TAGRISSO (TABLET) (ORAL) OSIMERTINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 208065  Prod. No.: 001 RX (EQ 40MG BASE); 002 RX (EQ 80MG BASE)

Patents	Expiration	Change
Pat. No. 8946235 DS* DP* 2-(2,4,5-substituted-anilino) pyrimidine compounds Pat. Sub. Date(s): All strengths: Dec 11, 2015 Claim Types: Compound; Composition; Method of use Use Code: U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy Use Code: U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations Use Code: U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations Use Code: U-3823: Treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations in combination with pemetrexed and platinum-based chemotherapy	Aug 8, 2032	New Use Code
Pat. No. 9732058 DS* DP* 2-(2,4,5-substituted-anilino)pyrimidine compounds Pat. Sub. Date(s): All strengths: Aug 29, 2017 Claim Types: Compound; Composition; Method of use Use Code: U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy Use Code: U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations Use Code: U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations Use Code: U-3823: Treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations in combination with pemetrexed and platinum-based chemotherapy	Jul 25, 2032	New Use Code
Pat. No. 10183020 DP* Pharmaceutical compositions comprising AZD9291 Pat. Sub. Date(s): All strengths: Feb 12, 2019 Claim Types: Formulation; Method of use Use Code: U-1777: Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after EGFR TKI therapy Use Code: U-2289: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21L858R mutations Use Code: U-3016: Adjuvant therapy after tumor resection in patients with non-small cell lung cancer(NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19deletions or exon 21 L858R mutations Use Code: U-3823: Treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations in combination with pemetrexed and platinum-based chemotherapy	Jan 2, 2035	New Use Code

TALICIA (CAPSULE, DELAYED RELEASE) (ORAL) AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
Drug Classes: penicillin class antibacterial == proton pump inhibitor == rifamycin antimycobacterial
NDA Applicant: REDHILL      NDA No.: 213004  Prod. No.: 001 RX (250MG;EQ 10MG BASE;12.5MG)

Patents	Expiration	Change
Pat. No. 11931463 DP* All-in-one fixed-dose combination for treating Helicobacter pylori infection Pat. Sub. Date(s): 001: Apr 4, 2024 Claim Types: Formulation Use Code: U-3866: Treatment of helicobacter pylori infection in adults using specified dosage form	Feb 12, 2034	New patent for this product

TALZENNA (CAPSULE) (ORAL) TALAZOPARIB TOSYLATE
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: PFIZER      NDA No.: 217439  Prod. No.: 001 RX (EQ 0.1MG BASE); 002 RX (EQ 0.25MG BASE); 003 RX (EQ 0.35MG BASE); 004 RX (EQ 0.5MG BASE); 005 RX (EQ 0.75MG BASE); 006 RX (EQ 1MG BASE)

Patents	Expiration	Change
Pat. No. 8012976 DS* DP* Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) Pat. Sub. Date(s): All strengths: Apr 5, 2024 Claim Types: Compound; Composition	Oct 19, 2029	New product in Orange Book
Pat. No. 8420650 DS* DP* Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) Pat. Sub. Date(s): All strengths: Apr 5, 2024 Claim Types: Compound	Jul 27, 2029	New product in Orange Book
Pat. No. 8735392 DS* DP* Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,- 9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt Pat. Sub. Date(s): All strengths: Apr 5, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Oct 20, 2031	New product in Orange Book
Pat. No. 9820985 Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) Pat. Sub. Date(s): All strengths: Apr 5, 2024 Claim Types: Method of use Use Code: U-2437: Treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (GBRCAM) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer	Jul 27, 2029	New product in Orange Book
Pat. No. 10189837 DS* DP* Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,- 9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt Pat. Sub. Date(s): All strengths: Apr 5, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Oct 20, 2031	New product in Orange Book
Pat. No. 10780088 Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) Pat. Sub. Date(s): All strengths: Apr 5, 2024 Claim Types: Method of use Use Code: U-3651: Treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (MCRPC) in combination with enzalutamide	Jul 27, 2029	New product in Orange Book

TRADJENTA (TABLET) (ORAL) LINAGLIPTIN [GENERIC AB]
Drug Classes: dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 201280  Prod. No.: 001 RX (5MG)

Patents	Expiration	Change
Pat. No. 11911388 Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral or non-oral antidiabetic drug Pat. Sub. Date(s): 001: Mar 25, 2024 Claim Types: Method of use Use Code: U-3854: Linagliptin (5 mg daily dose) and metformin (with or without insulin) for treating type 2 diabetes patients with renal impairment and insufficient glycemic control despite previous treatment with metformin alone or in combination with insulin	Apr 10, 2030	New patent for this product

TYRVAYA (SPRAY) (NASAL) VARENICLINE TARTRATE
Drug Classes: cholinergic agonist == nicotinic receptor partial agonist
NDA Applicant: OYSTER POINT PHARMA      NDA No.: 213978  Prod. No.: 001 RX (EQ 0.03MG BASE/SPRAY)

Patents	Expiration	Change
Pat. No. 11903941 Compositions and use of varenicline for treating dry eye Pat. Sub. Date(s): 001: Mar 8, 2024 Claim Types: Method of use Use Code: U-1900: Treatment of the signs and symptoms of dry eye disease (DED)	Oct 19, 2035	New patent for this product
Pat. No. 11903942 DP* Compositions and use of varenicline for treating dry eye Pat. Sub. Date(s): 001: Mar 8, 2024 Claim Types: Formulation; Drug in a container	Oct 19, 2035	New patent for this product
Pat. No. 11903943 Compositions and use of varenicline for treating dry eye Pat. Sub. Date(s): 001: Mar 8, 2024 Claim Types: Method of use Use Code: U-1900: Treatment of the signs and symptoms of dry eye disease (DED)	Oct 19, 2035	New patent for this product
Pat. No. 11911380 Compositions and use of varenicline for treating dry eye Pat. Sub. Date(s): 001: Mar 8, 2024 Claim Types: Method of use Use Code: U-1900: Treatment of the signs and symptoms of dry eye disease (DED)	Oct 19, 2035	New patent for this product

TYVASO (SOLUTION) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 022387  Prod. No.: 001 RX (0.6MG/ML)

Patents	Expiration	Change
Pat. No. 11826327 Treatment for interstitial lung disease Pat. Sub. Date(s): 001: Nov 28, 2023 Claim Types: Method of use Use Code: U-3749: Method of treating pulmonary hypertension associated with interstitial lung disease by administering treprostinil or a salt thereof by inhalation using a device	Feb 3, 2042	New expiration date. Was previously Jan 4, 2042

TYVASO DPI (POWDER) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 214324  Prod. No.: 001 RX (0.016MG/INH); 002 RX (0.032MG/INH); 003 RX (0.048MG/INH); 004 RX (0.064MG/INH)

Patents	Expiration	Change
Pat. No. 11826327 Treatment for interstitial lung disease Pat. Sub. Date(s): All strengths: Nov 28, 2023 Claim Types: Method of use Use Code: U-3749: Method of treating pulmonary hypertension associated with interstitial lung disease by administering treprostinil or a salt thereof by inhalation using a device	Feb 3, 2042	New expiration date. Was previously Jan 4, 2042

VAFSEO (TABLET) (ORAL) VADADUSTAT
NDA Applicant: AKEBIA      NDA No.: 215192  Prod. No.: 001 RX (150MG); 002 RX (300MG); 003 RX (450MG)

Patents	Expiration	Change
Pat. No. 7811595 DS* DP* Prolyl hydroxylase inhibitors and methods of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Compound; Composition	Mar 13, 2028	New product in Orange Book
Pat. No. 8343952 DS* DP* Prolyl hydroxylase inhibitors and methods of use Pat. Sub. Date(s): All strengths: Apr 10, 2024 Claim Types: Composition; Compound	Aug 14, 2027	New product in Orange Book

VEKLURY (POWDER) (INTRAVENOUS) REMDESIVIR
Drug Classes: SARS-CoV-2 nucleotide analog RNA polymerase inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 214787  Prod. No.: 001 RX (100MG/VIAL)

Patents	Expiration	Change
Pat. No. 10695361 Methods for treating arenaviridae and coronaviridae virus infections Pat. Sub. Date(s): 001: Nov 12, 2020 Claim Types: Method of use Use Code: U-3831: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) requiring hospitalization Use Code: U-3832: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg)	Mar 16, 2037 *PED	New Use Code; Deleted Use Code(s): U-2984, U-3249, U-3367, U-3368
Pat. No. 11007208 Methods for treating arenaviridae and coronaviridae virus infections Pat. Sub. Date(s): 001: Jun 15, 2021 Claim Types: Method of use Use Code: U-3831: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) requiring hospitalization Use Code: U-3832: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg)	Mar 16, 2037 *PED	New Use Code; Deleted Use Code(s): U-2984, U-3249, U-3367, U-3368
Pat. No. 11266681 Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections Pat. Sub. Date(s): 001: Apr 4, 2022 Claim Types: Method of use Use Code: U-3831: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) requiring hospitalization Use Code: U-3832: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg)	Jan 10, 2039 *PED	New Use Code; Deleted Use Code(s): U-2984, U-3249, U-3367, U-3368
Pat. No. 11382926 Methods for treating Arenaviridae and Coronaviridae virus infections Pat. Sub. Date(s): 001: Aug 2, 2022 Claim Types: Method of use Use Code: U-3831: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) requiring hospitalization Use Code: U-3832: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg)	Mar 16, 2037 *PED	New Use Code
Pat. No. 11491169 Remdesivir treatment methods Pat. Sub. Date(s): 001: Dec 6, 2022 Claim Types: Method of use Use Code: U-3835: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) requiring hospitalization and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended Use Code: U-3836: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended	Nov 28, 2041 *PED	New Use Code
Pat. No. 11903953 Remdesivir treatment methods Pat. Sub. Date(s): 001: Mar 19, 2024 Claim Types: Method of use Use Code: U-3835: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) requiring hospitalization and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended Use Code: U-3836: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended	Nov 28, 2041 *PED	New patent for this product

VEKLURY (SOLUTION) (INTRAVENOUS) REMDESIVIR
Drug Classes: SARS-CoV-2 nucleotide analog RNA polymerase inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 214787  Prod. No.: 002 RX (100MG/20ML (5MG/ML))

Patents	Expiration	Change
Pat. No. 10695361 Methods for treating arenaviridae and coronaviridae virus infections Pat. Sub. Date(s): 002: Nov 12, 2020 Claim Types: Method of use Use Code: U-3829: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (weighing at least 40 kg) requiring hospitalization Use Code: U-3830: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (weighing at least 40 kg)	Mar 16, 2037 *PED	New Use Code; Deleted Use Code(s): U-2984, U-3249, U-3367, U-3368
Pat. No. 11007208 Methods for treating arenaviridae and coronaviridae virus infections Pat. Sub. Date(s): 002: Jun 15, 2021 Claim Types: Method of use Use Code: U-3829: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (weighing at least 40 kg) requiring hospitalization Use Code: U-3830: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (weighing at least 40 kg)	Mar 16, 2037 *PED	New Use Code; Deleted Use Code(s): U-2984, U-3249, U-3367, U-3368
Pat. No. 11382926 Methods for treating Arenaviridae and Coronaviridae virus infections Pat. Sub. Date(s): 002: Aug 2, 2022 Claim Types: Method of use Use Code: U-3829: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (weighing at least 40 kg) requiring hospitalization Use Code: U-3830: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (weighing at least 40 kg)	Mar 16, 2037 *PED	New Use Code
Pat. No. 11491169 Remdesivir treatment methods Pat. Sub. Date(s): 002: Dec 6, 2022 Claim Types: Method of use Use Code: U-3833: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (weighing at least 40 kg) requiring hospitalization and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended Use Code: U-3834: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (weighing at least 40 kg) and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended	Nov 28, 2041 *PED	New Use Code
Pat. No. 11903953 Remdesivir treatment methods Pat. Sub. Date(s): 002: Mar 19, 2024 Claim Types: Method of use Use Code: U-3837: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (weighing at least 40 kg) requiring hospitalization and for whom concomitant use of chloroquine, or an analog or salt thereof, if not recommended Use Code: U-3838: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (weighing at least 40 kg) and for whom concomitant use of chloroquine, or an analog or salt thereof, if not recommended	Nov 28, 2041 *PED	New patent for this product
Pat. No. 10675296 DP* Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections Pat. Sub. Date(s): None Claim Types: Formulation	Jan 10, 2039 *PED	This patent is no longer listed for this product
Pat. No. 11266681 Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-2984: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (at least 12 years of age and 40 kg) requiring hospitalization Use Code: U-3249: Treatment of coronavirus disease 2019 (covid-19) in non-hospitalized adults and pediatric patients (at least 12 years of age and 40 kg) Use Code: U-3367: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (at least 28 days of age and 3 kg) requiring hospitalization Use Code: U-3368: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (at least 28 days of age and 3 kg)	Jan 10, 2039 *PED	This patent is no longer listed for this product

VOSEVI (TABLET) (ORAL) SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
Drug Classes: hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor == hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 209195  Prod. No.: 001 RX (400MG;100MG;100MG)

Patents	Expiration	Change
Pat. No. 9585906 DS* DP* Nucleoside phosphoramidate prodrugs Pat. Sub. Date(s): None Claim Types: Compound; Composition; Method of use Use Code: U-2039: Treatment of adult patients with chronic HCV infection who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor Use Code: U-2040: Treatment of adult patients with chronic HCV infection who have genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor	Mar 21, 2028	This patent is no longer listed for this product

VYZULTA (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROSTENE BUNOD
NDA Applicant: BAUSCH AND LOMB      NDA No.: 207795  Prod. No.: 001 RX (0.024%)

Patents	Expiration	Change
Pat. No. 8058467 DS* Prostaglandin derivatives Pat. Sub. Date(s): 001: Nov 21, 2017 Claim Types: Compound; Method of use Use Code: U-2144: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension	Feb 21, 2029	New expiration date. Was previously Jan 5, 2025

WEGOVY (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.: 215256  Prod. No.: 001 RX (0.25MG/0.5ML (0.25MG/0.5ML)); 002 RX (0.5MG/0.5ML (0.5MG/0.5ML)); 003 RX (1MG/0.5ML (1MG/0.5ML)); 004 RX (1.7MG/0.75ML (1.7MG/0.75ML)); 005 RX (2.4MG/0.75ML (2.4MG/0.75ML))

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-935: In combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight	Mar 8, 2027	New exclusivity for this product

XARELTO (FOR SUSPENSION) (ORAL) RIVAROXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 215859  Prod. No.: 001 RX (1MG/ML)

Patents	Expiration	Change
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)] Substituted oxazolidinones and their use in the field of blood coagulation Pat. Sub. Date(s): 001: Jan 18, 2022 Claim Types: Compound; Process; Composition; Method of use	Feb 28, 2025 *PED	New expiration date. Was previously Aug 28, 2024