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

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. 12042494 DP* Pat. Sub. Date(s): 001: Aug 7, 2024 Claim Types: Use Code: U-3522: Method of treating emesis	Nov 18, 2030	New patent for this product

AMVUTTRA (SOLUTION) (SUBCUTANEOUS) VUTRISIRAN SODIUM
Drug Classes: transthyretin-directed small interfering RNA
NDA Applicant: ALNYLAM PHARMS INC      NDA No.: 215515  Prod. No.: 001 RX (EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML))

Patents	Expiration	Change
Pat. No. 12049628 DS* DP* Transthyretin (TTR) iRNA compositions and methods of use thereof for treating or preventing TTR-associated diseases Pat. Sub. Date(s): 001: Aug 28, 2024 Claim Types: New polymorph, salt or hydrate Use Code: U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults	Jul 28, 2036	New patent for this product

AUSTEDO (TABLET) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA BRANDED PHARM      NDA No.: 208082  Prod. No.: 001 RX (6MG); 002 RX (9MG); 003 RX (12MG)

Patents	Expiration	Change
Pat. No. 12016858 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 Claim Types: Method of use Use Code: U-1995: Treatment of tardive dyskinesia Use Code: U-3055: A method of treating Huntington's chorea	Sep 7, 2036 *PED	New expiration date. Was previously Mar 7, 2036

AUSTEDO XR (TABLET, EXTENDED RELEASE) (ORAL) DEUTETRABENAZINE
NDA Applicant: TEVA      NDA No.: 216354  Prod. No.: 001 RX (6MG); 002 RX (12MG); 003 RX (24MG); 004 RX (30MG); 005 RX (36MG); 006 RX (42MG); 007 RX (48MG); 008 RX (18MG)

Patents	Expiration	Change
Pat. No. 12016858 Methods for the treatment of abnormal involuntary movement disorders Pat. Sub. Date(s): All strengths: Jul 25, 2024 Claim Types: Method of use Use Code: U-1995: Treatment of tardive dyskinesia Use Code: U-3055: A method of treating Huntington's chorea	Sep 7, 2036 *PED	New expiration date. Was previously Mar 7, 2036

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)

Patents	Expiration	Change
Pat. No. 12060354 Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making Pat. Sub. Date(s): All strengths: Aug 14, 2024 Claim Types: Method of use; New polymorph, salt or hydrate Use Code: U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation	Mar 8, 2042	New patent for this product

BALVERSA (TABLET) (ORAL) ERDAFITINIB
Drug Classes: kinase inhibitor
NDA Applicant: JANSSEN BIOTECH      NDA No.: 212018  Prod. No.: 001 RX (3MG); 002 RX (4MG); 003 RX (5MG)

Patents	Expiration	Change
Pat. No. 12037644 Use of FGFR mutant gene panels in identifying cancer patients that will be responsive to treatment with an FGFR inhibitor Pat. Sub. Date(s): All strengths: Aug 15, 2024 Claim Types: Method of use Use Code: U-3972: Treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations (Y373C identified) whose disease has progressed on or after at least one line of prior systemic therapy	Oct 18, 2035	New patent for this product

CAMZYOS (CAPSULE) (ORAL) MAVACAMTEN
Drug Classes: cardiac myosin inhibitor
NDA Applicant: BRISTOL      NDA No.: 214998  Prod. No.: 001 RX (2.5MG); 002 RX (5MG); 003 RX (10MG); 004 RX (15MG)

Patents	Expiration	Change
Pat. No. RE50050 DS* DP* Pyrimidinedione compounds Pat. Sub. Date(s): All strengths: Aug 20, 2024 Claim Types: Compound; Composition; New polymorph, salt or hydrate	Jun 19, 2034	New patent for this product
Pat. No. 9181200 DS* DP* Pyrimidinedione compounds Pat. Sub. Date(s): None Claim Types: Compound; Composition	Jun 19, 2034	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. 12070459 DP* Pharmaceutical capsule compositions comprising lumateperone mono-tosylate Pat. Sub. Date(s): 001: Aug 29, 2024 Claim Types: Formulation Use Code: U-3362: Treatment of bipolar depression mediated by the 5-HT2A receptor, serotonin transporter, and/or dopamine d1/d2 signaling pathways Use Code: U-3363: Treatment of schizophrenia mediated by the 5-HT2A receptor, serotonin transporter, and/or dopamine D1/D2 signaling pathways	Aug 30, 2039	New patent for this product

CONTRAVE (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: aminoketone == opioid antagonist
NDA Applicant: NALPROPION      NDA No.: 200063  Prod. No.: 001 RX (90MG;8MG)

Patents	Expiration	Change
Pat. No. 12048769 Methods for administering weight loss medications Pat. Sub. Date(s): 001: Aug 19, 2024 Claim Types: Method of improving a treatment Use Code: U-1585: Use of naltrexone and bupropion based on an escalating dose schedule	Nov 8, 2027	New patent for this product

COSELA (POWDER) (INTRAVENOUS) TRILACICLIB DIHYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: G1 THERAP      NDA No.: 214200  Prod. No.: 001 RX (EQ 300MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 11040042 DP* Transient protection of normal cells during chemotherapy Pat. Sub. Date(s): 001: Jul 21, 2021 Claim Types: Composition	Oct 25, 2031	New expiration date. Was previously Mar 14, 2034

CREXONT (CAPSULE, EXTENDED RELEASE) (ORAL) CARBIDOPA; LEVODOPA
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: IMPAX      NDA No.: 217186  Prod. No.: 001 RX (35MG;140MG); 002 RX (52.5MG;210MG); 003 RX (70MG;280MG); 004 RX (87.5MG;350MG)

Patents	Expiration	Change
Pat. No. 10098845 DP* Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Aug 12, 2024 Claim Types: Formulation Use Code: U-219: Treatment of Parkinson's disease	Oct 7, 2034	New product in Orange Book
Pat. No. 10292935 DP* Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Aug 12, 2024 Claim Types: Formulation Use Code: U-219: Treatment of Parkinson's disease	Oct 7, 2034	New product in Orange Book
Pat. No. 10688058 DP* Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Aug 12, 2024 Claim Types: Method of use Use Code: U-219: Treatment of Parkinson's disease	Oct 7, 2034	New product in Orange Book
Pat. No. 10973769 DP* Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Aug 12, 2024 Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics; Formulation Use Code: U-219: Treatment of Parkinson's disease	Oct 7, 2034	New product in Orange Book
Pat. No. 10987313 DP* Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Aug 12, 2024 Claim Types: Formulation Use Code: U-219: Treatment of Parkinson's disease	Oct 7, 2034	New product in Orange Book
Pat. No. 11357733 DP* Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Aug 12, 2024 Claim Types: Formulation	Oct 7, 2034	New product in Orange Book
Pat. No. 11622941 DP* Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Aug 12, 2024 Claim Types: Formulation	Oct 7, 2034	New product in Orange Book
Pat. No. 11666538 DP* Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Aug 12, 2024 Claim Types: Formulation Use Code: U-219: Treatment of Parkinson's disease	Oct 7, 2034	New product in Orange Book
Pat. No. 11986449 Levodopa dosing regimen Pat. Sub. Date(s): All strengths: Aug 12, 2024 Claim Types: Method of use Use Code: U-219: Treatment of Parkinson's disease	Dec 21, 2041	New product in Orange Book
Pat. No. 12064521 DP* Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof Pat. Sub. Date(s): All strengths: Aug 21, 2024 Claim Types: Formulation	Oct 7, 2034	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Aug 7, 2027	New product in Orange Book

DAPTOMYCIN (POWDER) (INTRAVENOUS) DAPTOMYCIN [Has competitive generic]
Drug Classes: lipopeptide antibacterial
NDA Applicant: XELLIA PHARMS APS      NDA No.: 217415  Prod. No.: 001 RX (350MG/VIAL); 002 RX (500MG/VIAL)

Patents	Expiration	Change
Pat. No. 12053502 Daptomycin formulations Pat. Sub. Date(s): All strengths: Sep 4, 2024 Claim Types: Method of use Use Code: U-3981: Treatment of the following infections: complicated skin and skin structure infections and staphylococcus aureus blood stream infections	Aug 28, 2038	New patent for this product

DAYBUE (SOLUTION) (ORAL) TROFINETIDE
NDA Applicant: ACADIA PHARMS INC      NDA No.: 217026  Prod. No.: 001 RX (200MG/ML)

Patents	Expiration	Change
Pat. No. 11827600 DS* DP* Crystalline forms of trofinetide Pat. Sub. Date(s): 001: Aug 12, 2024 Claim Types: New polymorph, salt or hydrate; Kit; Process Use Code: U-3556: Treatment of Rett syndrome or a symptom thereof	Jul 12, 2042	New patent for this product

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

Patents	Expiration	Change
Pat. No. 10093663 Piperidinyl-indole derivatives complement factor B inhibitors and uses thereof Pat. Sub. Date(s): 001: Sep 4, 2024 Claim Types: Method of use Use Code: U-3980: Treatment of primary immunoglobulin a nephropathy (IGAN)	Jul 14, 2034	New patent for this product
Pat. No. 11723901 Uses of piperidinyl-indole derivatives Pat. Sub. Date(s): 001: Sep 4, 2024 Claim Types: Method of use Use Code: U-3980: Treatment of primary immunoglobulin a nephropathy (IGAN)	Aug 30, 2038	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-949: For the reduction of proteinuria in adults with primary immunoglobulin a nephropathy (IGAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR)>/= 1.5 g/g	Aug 7, 2027	New exclusivity for this product

FOCINVEZ (SOLUTION) (INTRAVENOUS) FOSAPREPITANT DIMEGLUMINE
NDA Applicant: STERISCIENCE      NDA No.: 216686  Prod. No.: 001 RX (EQ 150MG BASE/50ML (EQ 3MG BASE/ML))

Patents	Expiration	Change
Pat. No. 12042504 DP* Injectable fosaprepitant composition Pat. Sub. Date(s): 001: Aug 12, 2024 Claim Types: Method of use	Jan 11, 2039	New patent for this product

FRUZAQLA (CAPSULE) (ORAL) FRUQUINTINIB
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 217564  Prod. No.: 001 RX (1MG); 002 RX (5MG)

Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Nov 8, 2028	New expiration date. Was previously Nov 30, 2028

FYARRO (POWDER) (INTRAVENOUS) SIROLIMUS
Drug Classes: kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: AADI      NDA No.: 213312  Prod. No.: 001 RX (100MG/VIAL)

Patents	Expiration	Change
Pat. No. 12061183 DP* Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Pat. Sub. Date(s): 001: Aug 13, 2024 Claim Types: Method of improving a treatment	Mar 5, 2036	New patent for this product

IVABRADINE HYDROCHLORIDE (TABLET) (ORAL) IVABRADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: INGENUS PHARMS LLC      NDA No.: 214051  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 7.5MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Jan 15, 2025	New exclusivity 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. 12053461 DP* Amlodipine formulations Pat. Sub. Date(s): 001: Aug 15, 2024 Claim Types: Formulation	Oct 6, 2037	New patent for this product

KISQALI (TABLET) (ORAL) RIBOCICLIB SUCCINATE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 209092  Prod. No.: 001 RX (EQ 200MG BASE)

Patents	Expiration	Change
Pat. No. 8962630 Pyrrolopyrimidine compounds and their uses Pat. Sub. Date(s): 001: Apr 3, 2017 Claim Types: Method of use Use Code: U-1981: In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer Use Code: U-2355: In combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy Use Code: U-2356: In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy Use Code: U-3265: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Use Code: U-3266: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer Use Code: U-3975: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy, for the treatment of adult patients with hr-positive, HER2-negative advanced or metastatic breast cancer	Dec 9, 2029	New Use Code
Pat. No. 9416136 Pyrrolopyrimidine compounds and their uses Pat. Sub. Date(s): 001: Apr 3, 2017 Claim Types: Method of use Use Code: U-1981: In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer Use Code: U-2355: In combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy Use Code: U-2356: In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy Use Code: U-3265: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Use Code: U-3266: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer Use Code: U-3975: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy, for the treatment of adult patients with hr-positive, HER2-negative advanced or metastatic breast cancer	Aug 20, 2029	New Use Code
Pat. No. 9868739 Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo- [2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof Pat. Sub. Date(s): 001: Jun 5, 2018 Claim Types: Method of use Use Code: U-1981: In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer Use Code: U-2355: In combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy Use Code: U-2356: In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy Use Code: U-3265: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Use Code: U-3266: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer Use Code: U-3975: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy, for the treatment of adult patients with hr-positive, HER2-negative advanced or metastatic breast cancer	Nov 9, 2031	New Use Code

LEQSELVI (TABLET) (ORAL) DEURUXOLITINIB PHOSPHATE
NDA Applicant: SUN PHARM INDS INC      NDA No.: 217900  Prod. No.: 001 RX (EQ 8MG BASE)

Patents	Expiration	Change
Pat. No. 10561659 Treatment of hair loss disorders with deuterated JAK inhibitors Pat. Sub. Date(s): 001: Aug 23, 2024 Claim Types: Method of use Use Code: U-3976: Treatment of adult patients with alopecia areata	May 4, 2037	New patent for this product
Pat. No. 11919907 DP* Deuterated JAK inhibitor and uses thereof Pat. Sub. Date(s): 001: Aug 23, 2024 Claim Types: Compound; Method of use Use Code: U-3976: Treatment of adult patients with alopecia areata	May 21, 2041	New patent for this product

LIVDELZI (CAPSULE) (ORAL) SELADELPAR LYSINE
NDA Applicant: CYMABAY      NDA No.: 217899  Prod. No.: 001 RX (EQ 10MG BASE)

Patents	Expiration	Change
Pat. No. 7301050 DS* DP* 4-((phenoxyalkyl)thio)-phenoxyacetic acids and analogs Pat. Sub. Date(s): 001: Aug 30, 2024 Claim Types: Compound; Composition	Aug 2, 2025	New product in Orange Book
Pat. No. 7709682 DS* Lysine salts of 4-((phenoxyalkyl)thio)-phenoxyacetic acid derivatives Pat. Sub. Date(s): 001: Aug 30, 2024 Claim Types: New polymorph, salt or hydrate	Sep 13, 2026	New product in Orange Book
Pat. No. 9486428 Treatment of intrahepatic cholestatic diseases Pat. Sub. Date(s): 001: Aug 30, 2024 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 19, 2035	New product in Orange Book
Pat. No. 10272058 Treatment of intrahepatic cholestatic diseases Pat. Sub. Date(s): 001: Aug 30, 2024 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 19, 2035	New product in Orange Book
Pat. No. 11406611 Treatment of intrahepatic cholestatic diseases Pat. Sub. Date(s): 001: Aug 30, 2024 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 19, 2035	New product in Orange Book
Pat. No. 11596614 Treatment of intrahepatic cholestatic diseases Pat. Sub. Date(s): 001: Aug 30, 2024 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 19, 2035	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Aug 14, 2029	New product in Orange Book

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. 11229647 Methods for treating cholestasis Pat. Sub. Date(s): 001: Feb 1, 2022 Claim Types: Method of use Use Code: U-3290: Treatment of cholestatic pruritus in patients with alagille syndrome (ALGS) Use Code: U-3974: Treatment of cholestatic pruritus in patients 3 months of age and older with alagille syndrome (ALGS)	Feb 12, 2040	New Use Code
Pat. No. 11260053 Bile acid recycling inhibitors and satiogens for treatment of diabetes, obesity, and inflammatory gastrointestinal conditions Pat. Sub. Date(s): 001: Mar 1, 2022 Claim Types: Method of use Use Code: U-3290: Treatment of cholestatic pruritus in patients with alagille syndrome (ALGS) Use Code: U-3974: Treatment of cholestatic pruritus in patients 3 months of age and older with alagille syndrome (ALGS)	May 26, 2031	New Use Code
Pat. No. 11376251 Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases Pat. Sub. Date(s): 001: Jul 19, 2022 Claim Types: Method of use Use Code: U-3290: Treatment of cholestatic pruritus in patients with alagille syndrome (ALGS) Use Code: U-3974: Treatment of cholestatic pruritus in patients 3 months of age and older with alagille syndrome (ALGS)	Oct 26, 2032	New Use Code
Pat. No. 11497745 Methods for treating cholestasis Pat. Sub. Date(s): 001: Nov 30, 2022 Claim Types: Method of use Use Code: U-3290: Treatment of cholestatic pruritus in patients with alagille syndrome (ALGS) Use Code: U-3974: Treatment of cholestatic pruritus in patients 3 months of age and older with alagille syndrome (ALGS)	Feb 12, 2040	New Use Code
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) Use Code: U-3974: Treatment of cholestatic pruritus in patients 3 months of age and older with alagille syndrome (ALGS)	Feb 12, 2040	New Use Code

LIVMARLI (SOLUTION) (ORAL) MARALIXIBAT CHLORIDE
Drug Classes: ileal bile acid transporter (IBAT) inhibitor
NDA Applicant: MIRUM      NDA No.: 214662  Prod. No.: 002 RX (EQ 19MG BASE/ML)

Patents	Expiration	Change
Pat. No. 10512657 Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases Pat. Sub. Date(s): 002: Aug 23, 2024 Claim Types: Method of use Use Code: U-3973: Treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (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): 002: Aug 23, 2024 Claim Types: Method of use Use Code: U-3973: Treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC)	Oct 26, 2032	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Sep 29, 2026	New exclusivity for this product

LOFEXIDINE HYDROCHLORIDE (TABLET) (ORAL) LOFEXIDINE HYDROCHLORIDE [GENERIC AB]
NDA Applicant: INDOCO      NDA No.: 218613  Prod. No.: 001 RX (EQ 0.18MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Feb 24, 2025	New product in Orange Book

LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 208558  Prod. No.: 001 RX (100MG); 002 RX (150MG)

Patents	Expiration	Change
Pat. No. 12048695 DP* Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Pat. Sub. Date(s): All strengths: Aug 23, 2024 Claim Types: Formulation	Oct 7, 2029	New patent for this product

MEKINIST (TABLET) (ORAL) TRAMETINIB DIMETHYL SULFOXIDE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 204114  Prod. No.: 001 RX (EQ 0.5MG); 003 RX (EQ 2MG) NDA No.: 204114  Prod. No.: 002 DISC (EQ 1MG**)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-908: Treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600 mutation who require systemic therapy	Sep 16, 2026 PED	New expiration date. Was previously Mar 16, 2026
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-428: Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Sep 16, 2030 PED	New expiration date. Was previously Mar 16, 2030

MEKINIST (SOLUTION) (ORAL) TRAMETINIB DIMETHYL SULFOXIDE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 217513  Prod. No.: 001 RX (EQ 0.05MG BASE/ML)

Patents	Expiration	Change
Pat. No. 7378423 DS* DP* Pyrimidine compound and medical use thereof Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Compound; Composition; Formulation	Nov 29, 2027 *PED	New expiration date. Was previously May 29, 2027
Pat. No. 8703781 DS* DP* Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Formulation; Method of use Use Code: U-3564: MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Apr 15, 2031 *PED	New expiration date. Was previously Oct 15, 2030
Pat. No. 8835443 Pyrimidine compound and medical use thereof Pat. Sub. Date(s): 001: May 4, 2023 Claim Types: Method of use Use Code: U-3564: MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Dec 10, 2025 *PED	New expiration date. Was previously Jun 10, 2025
Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Sep 16, 2026 PED	New expiration date. Was previously Mar 16, 2026
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-428: Treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy	Sep 16, 2030 PED	New expiration date. Was previously Mar 16, 2030

MOTPOLY XR (CAPSULE, EXTENDED RELEASE) (ORAL) LACOSAMIDE
NDA Applicant: AUCTA      NDA No.: 216185  Prod. No.: 001 RX (100MG); 002 RX (150MG); 003 RX (200MG)

Patents	Expiration	Change
Pat. No. 11883374 DP* Lacosamide pharmaceutical composition and dosage form thereof Pat. Sub. Date(s): All strengths: Aug 21, 2024 Claim Types: Device; Formulation; Formulation claimed by its inherent performace characteristics; Method of use Use Code: U-3660: Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg Use Code: U-3954: Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg	Jun 5, 2040	New patent for this product
Pat. No. 12042474 DP* Lacosamide pharmaceutical composition and dosage form thereof Pat. Sub. Date(s): All strengths: Aug 21, 2024 Claim Types: Formulation Use Code: U-3660: Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg Use Code: U-3954: Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg	Jun 5, 2040	New patent for this product

MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON [GENERIC AB]
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI      NDA No.: 202611  Prod. No.: 001 RX (25MG); 002 RX (50MG)

Patents	Expiration	Change
Pat. No. 12059409 DP* Pat. Sub. Date(s): All strengths: Aug 28, 2024 Claim Types:	Sep 28, 2029	New patent for this product

NEFFY (SPRAY) (NASAL) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARS PHARMS OPERATION      NDA No.: 214697  Prod. No.: 001 RX (2MG/SPRAY)

Patents	Expiration	Change
Pat. No. 10576156 DP* Compositions for drug administration Pat. Sub. Date(s): 001: Aug 28, 2024 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Feb 6, 2038	New product in Orange Book
Pat. No. 10682414 Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 001: Aug 28, 2024 Claim Types: Method of use Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis	Feb 6, 2039	New product in Orange Book
Pat. No. 11173209 Compositions for drug administration Pat. Sub. Date(s): 001: Aug 28, 2024 Claim Types: Method of use Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis	Feb 6, 2038	New product in Orange Book
Pat. No. 11191838 DP* Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 001: Aug 28, 2024 Claim Types: Method of use; Formulation Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis	Feb 6, 2039	New product in Orange Book
Pat. No. 11717571 Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 001: Aug 28, 2024 Claim Types: Method of use Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis	Feb 6, 2039	New product in Orange Book
Pat. No. 11744895 Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 001: Aug 28, 2024 Claim Types: Method of use Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis	Feb 6, 2039	New product in Orange Book
Pat. No. 11918655 DP* Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 001: Aug 28, 2024 Claim Types: Method of use; Formulation Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis	Feb 6, 2039	New product in Orange Book

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. 12059497 DP* Stabilizing camptothecin pharmaceutical compositions Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Oct 15, 2036	New patent for this product

ONUREG (TABLET) (ORAL) AZACITIDINE
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: BRISTOL      NDA No.: 214120  Prod. No.: 001 RX (200MG); 002 RX (300MG)

Patents	Expiration	Change
Pat. No. 12053482 Oral formulations of cytidine analogs and methods of use thereof Pat. Sub. Date(s): All strengths: Aug 28, 2024 Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Use Code: U-2950: Continued treatment of adults with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy	May 14, 2029	New patent for this product

OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 022272  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)

Patents	Expiration	Change
Pat. No. 12060361 DP* Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone Pat. Sub. Date(s): All strengths: Aug 15, 2024 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.	Mar 30, 2025	New patent for this product

PHYRAGO (TABLET) (ORAL) DASATINIB [Has competitive generic]
Drug Classes: kinase inhibitor
NDA Applicant: NANOCOPOEIA      NDA No.: 216099  Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (70MG); 004 RX (80MG); 005 RX (100MG); 006 RX (140MG)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-307: Information added to the clinical pharmacology section to include results from a drug interaction study with gastric acid reducing agents	Dec 5, 2026	New exclusivity 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. 12059410 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: Aug 13, 2024 Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Use Code: U-3153: Treatment of advanced gastrointestinal stromal tumor in patients having progressed from a first line administration of imatinib, a second line administration of sunitinib, and a third line administration of regorafenib	Aug 12, 2040	New patent for this product
Pat. No. 12059411 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: Aug 13, 2024 Claim Types: Method of use Use Code: U-3971: Treatment of gastrointestinal stromal tumors in patients suffering from palmar-plantar erythrodysesthesia syndrome	Aug 12, 2040	New patent for this product
Pat. No. 12064422 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: Aug 20, 2024 Claim Types: Method of use Use Code: U-3219: Treatment of gastrointestinal stromal tumor	Dec 30, 2040	New patent for this product

REZLIDHIA (CAPSULE) (ORAL) OLUTASIDENIB
NDA Applicant: RIGEL PHARMS      NDA No.: 215814  Prod. No.: 001 RX (150MG)

Patents	Expiration	Change
Pat. No. 12053463 DS* DP* Solid forms of ((s)-5-((1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethyl)amino)-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile Pat. Sub. Date(s): 001: Aug 28, 2024 Claim Types: New polymorph, salt or hydrate	May 16, 2039	New patent for this product

SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA      NDA No.: 211230  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 12036194 Methods of administering solriamfetol to lactating women Pat. Sub. Date(s): All strengths: Aug 5, 2024 Claim Types: Method of use Use Code: U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol	Dec 30, 2042	New patent for this product
Pat. No. 12064411 Methods of administering solriamfetol to lactating women Pat. Sub. Date(s): All strengths: Aug 26, 2024 Claim Types: Method of improving a treatment Use Code: U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol	Dec 30, 2042	New patent for this product

TABRECTA (TABLET) (ORAL) CAPMATINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS PHARM      NDA No.: 213591  Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 200MG BASE)

Patents	Expiration	Change
Pat. No. 7767675 DS* DP* Imidazotriazines and imidazopyrimidines as kinase inhibitors Pat. Sub. Date(s): All strengths: May 26, 2020 Claim Types: Compound; Method of use	Nov 19, 2032	New expiration date. Was previously Nov 19, 2027

TUKYSA (TABLET) (ORAL) TUCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: SEAGEN      NDA No.: 213411  Prod. No.: 001 RX (50MG); 002 RX (150MG)

Patents	Expiration	Change
Pat. No. 12048698 Treatment of HER2 positive cancers Pat. Sub. Date(s): All strengths: Aug 28, 2024 Claim Types: Method of use Use Code: U-3783: Combination treatment with tucatinib and trastuzumab of adults with ras wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following previous treatment as claimed	Apr 27, 2038	New patent for this product

TWYNEO (CREAM) (TOPICAL) BENZOYL PEROXIDE; TRETINOIN
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 214902  Prod. No.: 001 RX (3%;0.1%)

Patents	Expiration	Change
Pat. No. 12053546 DP* Stabilized topical formulations containing core-shell microcapsules Pat. Sub. Date(s): 001: Aug 26, 2024 Claim Types: Formulation	Jun 29, 2032	New patent for this product

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)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	May 23, 2025	New exclusivity for this product

VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS      NDA No.: 202057  Prod. No.: 001 RX (1GM); 002 RX (500MG)

Patents	Expiration	Change
Pat. No. 8367652 Methods of treating hypertriglyceridemia Pat. Sub. Date(s): None Claim Types: Method of administration Use Code: U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia	Feb 9, 2030	This patent is no longer listed for this product
Pat. No. 8377920 Methods of treating hypertriglyceridemia Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia	Feb 9, 2030	This patent is no longer listed for this product

VERZENIO (TABLET) (ORAL) ABEMACICLIB
Drug Classes: kinase inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 208716  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG)

Patents	Expiration	Change
Pat. No. 7855211 DS* DP* Protein kinase inhibitors Pat. Sub. Date(s): All strengths: Oct 16, 2017 Claim Types: Compound; Composition; Method of use Use Code: U-2135: As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting Use Code: U-3242: In combination with fulvestrant for the treatment of adult patients with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy Use Code: U-3265: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Use Code: U-3546: In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hr-positive, HER2-negative, node positive, early breast cancer at high risk of recurrence	Sep 28, 2031	New expiration date. Was previously Dec 15, 2029; New Use Code; Deleted Use Code(s): U-2132, U-2251, U-3241, U-3243

VERZENIO (TABLET) (ORAL) ABEMACICLIB
Drug Classes: kinase inhibitor
NDA Applicant: ELI LILLY AND CO      NDA No.: 208716  Prod. No.: 004 RX (200MG)

Patents	Expiration	Change
Pat. No. 7855211 DS* DP* Protein kinase inhibitors Pat. Sub. Date(s): 004: Oct 16, 2017 Claim Types: Compound; Composition; Method of use Use Code: U-1981: In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer Use Code: U-2135: As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting Use Code: U-3242: In combination with fulvestrant for the treatment of adult patients with HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy Use Code: U-3265: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Use Code: U-3546: In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hr-positive, HER2-negative, node positive, early breast cancer at high risk of recurrence	Sep 28, 2031	New expiration date. Was previously Dec 15, 2029; New Use Code

VOQUEZNA (TABLET) (ORAL) VONOPRAZAN FUMARATE
NDA Applicant: PHATHOM      NDA No.: 215151  Prod. No.: 001 RX (EQ 10MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-948: Use of vonoprazan for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults	Jul 17, 2027	New exclusivity for this product

VORANIGO (TABLET) (ORAL) VORASIDENIB
NDA Applicant: SERVIER      NDA No.: 218784  Prod. No.: 001 RX (10MG); 002 RX (40MG)

Patents	Expiration	Change
Pat. No. 9579324 DS* Therapeutically active compounds and their methods of use Pat. Sub. Date(s): All strengths: Aug 27, 2024 Claim Types: Compound	Jul 11, 2034	New product in Orange Book
Pat. No. 10172864 DS* DP* Therapeutically active compounds and their methods of use Pat. Sub. Date(s): All strengths: Aug 27, 2024 Claim Types: Compound	Jul 11, 2034	New product in Orange Book
Pat. No. 11345677 DS* DP* Cocrystals, pharmaceutical compositions thereof, and methods of treatment involving same Pat. Sub. Date(s): All strengths: Aug 27, 2024 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-3978: A method of treating a cancer characterized by an idh1 or idh2 mutation or combination thereof following surgery, wherein the cancer is Grade 2 astrocytoma or oligodendroglioma	Jan 16, 2039	New product in Orange Book
Pat. No. 11844758 Therapeutically active compounds and their methods of use Pat. Sub. Date(s): All strengths: Aug 27, 2024 Claim Types: Method of use Use Code: U-3977: A method of treating a glioma characterized by an IDHI mutation following surgery, wherein the glioma is Grade 2 astrocytoma or oligodendroglioma	Dec 4, 2035	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Aug 6, 2029	New product in Orange Book
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-491: Treatment of adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection	Aug 6, 2031	New product in Orange Book

WAKIX (TABLET) (ORAL) PITOLISANT HYDROCHLORIDE
Drug Classes: histamine-3 (H3) receptor antagonist/inverse agonist
NDA Applicant: HARMONY      NDA No.: 211150  Prod. No.: 001 RX (EQ 4.45MG BASE); 002 RX (EQ 17.8MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Jun 21, 2027	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-489: Treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy	Jun 21, 2031	New exclusivity for this product

YORVIPATH (SOLUTION) (SUBCUTANEOUS) PALOPEGTERIPARATIDE
NDA Applicant: ASCENDIS PHARMA BONE      NDA No.: 216490  Prod. No.: 001 RX (EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)); 002 RX (EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)); 003 RX (EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML))

Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-492: Treatment of hypoparathyroidism in adults	Aug 9, 2031	New product in Orange Book

YUPELRI (SOLUTION) (INHALATION) REVEFENACIN
Drug Classes: anticholinergic
NDA Applicant: MYLAN IRELAND LTD      NDA No.: 210598  Prod. No.: 001 RX (175MCG/3ML)

Patents	Expiration	Change
Pat. No. 7288657 DS* Biphenyl compounds useful as muscarinic receptor antagonists Pat. Sub. Date(s): 001: Nov 20, 2018 Claim Types: Compound; Process	Oct 31, 2028	New expiration date. Was previously Dec 23, 2025

ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS      NDA No.: 215985  Prod. No.: 001 RX (0.3%)

Patents	Expiration	Change
Pat. No. 12042487 DP* Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Pat. Sub. Date(s): 001: Aug 21, 2024 Claim Types: Formulation	Jun 7, 2037	New patent for this product

ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS      NDA No.: 215985  Prod. No.: 002 RX (0.15%)

Patents	Expiration	Change
Pat. No. 9884050 DP* Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Composition; Formulation	Jun 7, 2037	New patent for this product
Pat. No. 9907788 Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Method of use Use Code: U-3970: Topical treatment of mild to moderate atopic dermatitis	Jun 7, 2037	New patent for this product
Pat. No. 10940142 DP* Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Formulation	Jun 7, 2037	New patent for this product
Pat. No. 11129818 Topical roflumilast formulation having improved delivery and plasma half life Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Method of improving a treatment Use Code: U-3970: Topical treatment of mild to moderate atopic dermatitis	Aug 25, 2037	New patent for this product
Pat. No. 11793796 DP* Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Formulation	Jun 7, 2037	New patent for this product
Pat. No. 11819496 Topical roflumilast formulation having improved delivery and plasma half-life Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Method of use Use Code: U-3970: Topical treatment of mild to moderate atopic dermatitis	Jun 7, 2037	New patent for this product
Pat. No. 11992480 Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Method of improving a treatment Use Code: U-3970: Topical treatment of mild to moderate atopic dermatitis	Jun 7, 2037	New patent for this product
Pat. No. 12005051 Topical roflumilast formulation having improved delivery and plasma half life Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Method of improving a treatment Use Code: U-3970: Topical treatment of mild to moderate atopic dermatitis	Jun 7, 2037	New patent for this product
Pat. No. 12005052 DP* Topical roflumilast formulation having improved delivery and plasma half-life Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Formulation	Jun 7, 2037	New patent for this product
Pat. No. 12011437 DP* Roflumilast formulations with an improved pharmacokinetic profile Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Formulation	Jun 7, 2037	New patent for this product
Pat. No. 12016848 DP* Roflumilast formulations with an improved pharmacokinetic profile Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Jun 7, 2037	New patent for this product
Pat. No. 12042487 DP* Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Pat. Sub. Date(s): 002: Aug 8, 2024 Claim Types: Formulation	Jun 7, 2037	New patent for this product

ZORYVE (FOAM) (TOPICAL) ROFLUMILAST
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS      NDA No.: 217242  Prod. No.: 001 RX (0.3%)

Patents	Expiration	Change
Pat. No. 12042487 DP* Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Pat. Sub. Date(s): 001: Aug 16, 2024 Claim Types: Formulation	Jun 7, 2037	New patent for this product

ZUNVEYL (TABLET, DELAYED RELEASE) (ORAL) BENZGALANTAMINE GLUCONATE
NDA Applicant: ALPHA COGNITION      NDA No.: 218549  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 15MG BASE)

Patents	Expiration	Change
Pat. No. 9763953 Cholinergic enhancers with improved blood-brain barrier permeability for the treatment of diseases accompanied by cognitive impairment Pat. Sub. Date(s): All strengths: Aug 22, 2024 Claim Types: Method of use Use Code: U-713: Treatment of mild to moderate dementia of the Alzheimer's type	May 16, 2027	New patent for this product
Pat. No. 11795176 DS* Solid forms of Alpha-1062 gluconate Pat. Sub. Date(s): All strengths: Aug 22, 2024 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-713: Treatment of mild to moderate dementia of the Alzheimer's type	Jan 13, 2042	New patent for this product

ZURNAI (AUTOINJECTOR) (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALMEFENE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: PURDUE PHARMA LP      NDA No.: 218590  Prod. No.: 001 RX (EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML))

Patents	Expiration	Change
Pat. No. 8021335 DP* Prefilled syringe jet injector Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Oct 4, 2026	New product in Orange Book
Pat. No. 8496619 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Aug 21, 2031	New product in Orange Book
Pat. No. 8562564 DP* Prefilled syringe jet injector Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Jan 24, 2026	New product in Orange Book
Pat. No. 9180259 DP* Prefilled syringe jet injector Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Jan 24, 2026	New product in Orange Book
Pat. No. 9364610 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Aug 21, 2031	New product in Orange Book
Pat. No. 9364611 DP* Needle assisted jet injection device having reduced trigger force Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Aug 21, 2031	New product in Orange Book
Pat. No. 9446195 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Aug 21, 2031	New product in Orange Book
Pat. No. 9533102 DP* Prefilled syringe jet injector Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Jan 24, 2026	New product in Orange Book
Pat. No. 9629959 DP* Prefilled syringe jet injector Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Jan 24, 2026	New product in Orange Book
Pat. No. 10279131 DP* Injection device with cammed RAM assembly Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Jul 31, 2031	New product in Orange Book
Pat. No. 10357609 DP* Needle assisted jet injection device having reduced trigger force Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Aug 21, 2031	New product in Orange Book
Pat. No. 10478560 DP* Prefilled syringe injector Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Jan 24, 2026	New product in Orange Book
Pat. No. 10881798 DP* Needle assisted injection device having reduced trigger force Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Feb 11, 2034	New product in Orange Book
Pat. No. 10905827 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Aug 21, 2031	New product in Orange Book
Pat. No. 11185642 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device; Method of administration	Aug 28, 2031	New product in Orange Book
Pat. No. 11191908 DP* Syringe shock absorber for use in an injection device Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Oct 18, 2035	New product in Orange Book
Pat. No. 11446440 DP* Needle assisted injection device having reduced trigger force Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Aug 21, 2031	New product in Orange Book
Pat. No. 11446441 DP* Prefilled syringe injector Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Jan 24, 2026	New product in Orange Book
Pat. No. 11813435 DP* Needle assisted injection device having reduced trigger force Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Device	Feb 25, 2035	New product in Orange Book
Pat. No. 11857547 DP* Compositions and methods for opioid antagonist delivery Pat. Sub. Date(s): 001: Sep 5, 2024 Claim Types: Formulation claimed by its inherent performace characteristics	Nov 5, 2039	New product in Orange Book
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