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

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

Patents	Expiration	Change
Pat. No. 11452725 Chiral diaryl macrocycles and uses thereof Pat. Sub. Date(s): 001: Dec 12, 2023 Claim Types: Method of use Use Code: U-3755: Treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) Use Code: U-3961: Treatment of adult and pediatric patients >12 years with solid tumors and NTRK gene fusion that are locally advanced or metastatic or likely surgically unresectable, and have progressed following treatment or have no satisfactory alternative therapy	Jul 24, 2036	New Use Code

BORTEZOMIB (SOLUTION) (INTRAVENOUS) BORTEZOMIB
Drug Classes: proteasome inhibitor
NDA Applicant: MAIA PHARMS INC      NDA No.: 215331  Prod. No.: 001 DISC (3.5MG/3.5ML (1MG/ML)); 002 DISC (3.5MG/1.4ML (2.5MG/ML))

Patents	Expiration	Change
Pat. No. 12005069 DP* Bortezomib compositions Pat. Sub. Date(s): All strengths: Jun 20, 2024 Claim Types: Formulation	Sep 23, 2042	New patent for this product

CLINOLIPID 20% (EMULSION) (INTRAVENOUS) OLIVE OIL; SOYBEAN OIL
NDA Applicant: BAXTER HLTHCARE CORP      NDA No.: 204508  Prod. No.: 001 RX (16%(160GM/1000ML);4% (40GM/1000ML))

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Apr 24, 2027	New exclusivity 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. 11998542 Compositions and methods for reducing major adverse cardiovascular events Pat. Sub. Date(s): 001: Jul 5, 2024 Claim Types: Method of administration Use Code: U-1583: For chronic weight management for treating overweight or obesity	Jul 2, 2034	New patent for this product

CUPRIC CHLORIDE (INJECTABLE) (INJECTION) CUPRIC CHLORIDE [GENERIC AP]
NDA Applicant: SOMERSET      NDA No.: 216113  Prod. No.: 001 RX (EQ 0.4MG COPPER/ML)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Dec 21, 2024	New exclusivity for this product

DUOBRII (LOTION) (TOPICAL) HALOBETASOL PROPIONATE; TAZAROTENE
Drug Classes: corticosteroid == retinoid
NDA Applicant: BAUSCH      NDA No.: 209354  Prod. No.: 001 RX (0.01%;0.045%)

Patents	Expiration	Change
Pat. No. 11986527 Pharmaceutical formulations containing corticosteroids for topical administration Pat. Sub. Date(s): 001: Jun 13, 2024 Claim Types: Method of use Use Code: U-2625: Topical treatment of plaque psoriasis in adults	Nov 2, 2031	New patent for this product

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

Patents	Expiration	Change
Pat. No. 11986456 Method for treatment of rosacea Pat. Sub. Date(s): 001: Jun 17, 2024 Claim Types: Dosaage regimen Use Code: U-3947: Topical treatment of rosacea	Feb 19, 2040	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); 002 RX (10MG)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Dec 12, 2027 PED	New exclusivity 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. 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	Apr 7, 2033	New expiration date. Was previously Jan 25, 2033
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	Jan 25, 2033	New expiration date. Was previously Apr 7, 2033

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. 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	Apr 7, 2033	New expiration date. Was previously Jan 25, 2033
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	Jan 25, 2033	New expiration date. Was previously Apr 7, 2033

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

Patents	Expiration	Change
Pat. No. 11998528 Non-sedating dexmedetomidine treatment regimens Pat. Sub. Date(s): All strengths: Jun 20, 2024 Claim Types: Method of use Use Code: U-3935: Acute treatment of agitation associated with schizophrenia or bipolar I or II disorder by sublingual or buccal administration	Jan 12, 2043	New patent for this product

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

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsection	Aug 4, 2025	New exclusivity for this product

IMBRUVICA (TABLET) (ORAL) IBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PHARMACYCLICS LLC      NDA No.: 210563  Prod. No.: 001 RX (140MG); 002 RX (280MG); 003 RX (420MG) NDA No.: 210563  Prod. No.: 004 DISC (560MG)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsection	Aug 4, 2025	New exclusivity for this product

IQIRVO (TABLET) (ORAL) ELAFIBRANOR
NDA Applicant: IPSEN      NDA No.: 218860  Prod. No.: 001 RX (80MG)

Patents	Expiration	Change
Pat. No. 7632870 DP* Composition based on substituted 1,3-diphenylprop-2-en-1-one derivatives, preparation and uses thereof Pat. Sub. Date(s): 001: Jun 25, 2024 Claim Types: Composition; Method of use	Sep 9, 2024	New product in Orange Book
Pat. No. 7943661 DS* DP* Substituted 1,3-diphenylprop-2-en-1-one derivatives and preparation and uses thereof Pat. Sub. Date(s): 001: Jun 25, 2024 Claim Types: Compound; Process; Composition	Sep 9, 2024	New product in Orange Book
Pat. No. 11185519 Methods of treatment of cholestatic diseases Pat. Sub. Date(s): 001: Jun 25, 2024 Claim Types: Method of use Use Code: U-3955: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA	Mar 30, 2037	New product in Orange Book
Pat. No. 11331292 Methods of treatment of cholestatic diseases Pat. Sub. Date(s): 001: Jun 25, 2024 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 30, 2037	New product in Orange Book
Pat. No. 11850223 Methods of treatment of cholestatic diseases Pat. Sub. Date(s): 001: Jun 25, 2024 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 30, 2037	New product in Orange Book
Pat. No. 11857523 Methods of treatment of cholestatic diseases Pat. Sub. Date(s): 001: Jun 25, 2024 Claim Types: Method of use Use Code: U-3955: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA	Mar 30, 2037	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Jun 10, 2029	New product in Orange Book

JULUCA (TABLET) (ORAL) DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
Drug Classes: HIV integrase strand transfer inhibitor (HIV-1 INSTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 210192  Prod. No.: 001 RX (EQ 50MG BASE;EQ 25MG BASE)

Patents	Expiration	Change
Pat. No. 12011506 DP* Combination and uses and treatments thereof Pat. Sub. Date(s): 001: Jun 26, 2024 Claim Types: Formulation	Sep 5, 2038	New patent for this product

KRAZATI (TABLET) (ORAL) ADAGRASIB
NDA Applicant: MIRATI THERAPS      NDA No.: 216340  Prod. No.: 001 RX (200MG)

Patents	Expiration	Change
Pat. No. 10689377 DS* DP* KRas G12C inhibitors Pat. Sub. Date(s): 001: Dec 20, 2022 Claim Types: Compound; Composition; Method of use Use Code: U-3490: Treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an fda approved test, who have received at least one prior systemic therapy Use Code: U-3953: Treatment, in combination with cetuximab, of adult patients with KRAS G12C-muted locally advanced or metastatic colorectal cancer, per FDA approved test, where prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy	May 17, 2037	New Use Code

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)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsection	Oct 3, 2027 PED	New exclusivity for this product

LILETTA (SYSTEM) (INTRAUTERINE) LEVONORGESTREL
Drug Classes: progestin == progestin-containing intrauterine system
NDA Applicant: MEDICINES360      NDA No.: 206229  Prod. No.: 001 RX (52MG)

Patents	Expiration	Change
Pat. No. 12004992 DS* Kits for intrauterine systems and IUD insertion devices Pat. Sub. Date(s): 001: Jul 3, 2024 Claim Types: Kit	Oct 6, 2033	New patent for this product

LIQREV (SUSPENSION) (ORAL) SILDENAFIL CITRATE
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: CMP DEV LLC      NDA No.: 214952  Prod. No.: 001 RX (EQ 10MG BASE/ML)

Patents	Expiration	Change
Pat. No. 12005062 DP* Liquid oral formulations for sildenafil Pat. Sub. Date(s): 001: Jun 28, 2024 Claim Types: Formulation; Method of use Use Code: U-3582: LIQREV is indicated for the treatment of pulmonary arterial hypertension (WHO group 1) in adults to improve exercise ability and delay clinical worsening	Dec 24, 2038	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)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Oct 23, 2027 PED	New exclusivity for this product

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. 11337943 DP* Lacosamide pharmaceutical composition and dosage form thereof Pat. Sub. Date(s): All strengths: Aug 1, 2023 Claim Types: Formulation; Method of use; Method of Use claimed by its inherent performace characteristics 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 Use Code

MYCAPSSA (CAPSULE, DELAYED RELEASE) (ORAL) OCTREOTIDE ACETATE
Drug Classes: somatostatin analog
NDA Applicant: CHIESI      NDA No.: 208232  Prod. No.: 001 RX (EQ 20MG BASE)

Patents	Expiration	Change
Pat. No. 11986529 Pharmaceutical compositions and related methods of delivery Pat. Sub. Date(s): 001: Jun 14, 2024 Claim Types: Method of use Use Code: U-2857: Use of oral octreotide for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide	Sep 17, 2029	New patent for this product

NORLIQVA (SOLUTION) (ORAL) AMLODIPINE BESYLATE
Drug Classes: calcium channel blocker == dihydropyridine calcium channel blocker
NDA Applicant: CMP DEV LLC      NDA No.: 214439  Prod. No.: 001 RX (EQ 1MG BASE/ML)

Patents	Expiration	Change
Pat. No. 12005141 DP* Pharmaceutical solution of amlodipine Pat. Sub. Date(s): 001: Jun 28, 2024 Claim Types: Formulation; Method of use Use Code: U-3309: NORLIQVA is indicated for the treatment of hypertension, to lower blood pressure in adults and children 6 years of age and older Use Code: U-3310: NORLIQVA is indicated for the symptomatic treatment of chronic stable angina	Feb 24, 2041	New patent for this product

OGSIVEO (TABLET) (ORAL) NIROGACESTAT HYDROBROMIDE
NDA Applicant: SPRINGWORKS      NDA No.: 217677  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 12011434 Treatments with nirogacestat Pat. Sub. Date(s): All strengths: Jun 24, 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. 12011435 Treatments with nirogacestat Pat. Sub. Date(s): All strengths: Jun 24, 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

PEDMARK (SOLUTION) (INTRAVENOUS) SODIUM THIOSULFATE
NDA Applicant: FENNEC PHARMS INC      NDA No.: 212937  Prod. No.: 001 RX (12.5GM/100ML (125MG/ML))

Patents	Expiration	Change
Pat. No. 11992530 Therapeutic uses for sodium thiosulfate and formulations Pat. Sub. Date(s): 001: Jun 20, 2024 Claim Types: Method of improving a treatment Use Code: U-3948: Use of a pharmaceutical composition having about 0.5m aqueous anhydrous sodium thiosulfate and a concentration of borate ions of less than 0.05% for reducing ototoxicity in a pediatric patient receiving cisplatin for treatment of localized cancer	Jul 1, 2039	New patent for this product
Pat. No. 11998604 Therapeutic uses for sodium thiosulfate formulations Pat. Sub. Date(s): 001: Jun 24, 2024 Claim Types: Method of improving a treatment Use Code: U-3952: Use of a pharmaceutical composition having a concentration of about 0.5m aqueous anhydrous sodium thiosulfate and about 0.004m boric acid for reducing ototoxicity in a pediatric patient receiving cisplatin for treatment of localized cancer	Jul 1, 2039	New patent for this product

PHEXXI (GEL) (VAGINAL) CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
NDA Applicant: EVOFEM INC      NDA No.: 208352  Prod. No.: 001 RX (1%;1.8%;0.4%)

Patents	Expiration	Change
Pat. No. 11992472 Compositions and methods for enhancing the efficacy of contraceptive microbicides Pat. Sub. Date(s): 001: Jun 26, 2024 Claim Types: Method of use Use Code: U-1: Prevention of pregnancy	Mar 15, 2033	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. 12023325 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: Jul 3, 2024 Claim Types: Method of use Use Code: U-3960: Treatment of advanced gastrointestinal stromal tumor in patients previously administered imatinib	Aug 12, 2040	New patent for this product
Pat. No. 12023326 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: Jul 3, 2024 Claim Types: Method of use Use Code: U-3959: Treatment of gastrointestinal stromal tumors in a patient suffering from grade 2 arthralgia while being administered ripretinib daily	Aug 12, 2040	New patent for this product
Pat. No. 12023327 Methods of treating gastrointestinal stromal tumors Pat. Sub. Date(s): 001: Jul 3, 2024 Claim Types: Method of use Use Code: U-3958: Treatment of advanced gastrointestinal stromal tumor in patients previously administered 4 lines of prior therapy, where the first line of prior therapy is imatinib	Aug 12, 2040	New patent for this product
Pat. No. 12023328 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: Jul 3, 2024 Claim Types: Method of use Use Code: U-3957: Treatment of gastrointestinal stromal tumor comprising administering once daily, one or more tablets comprising ripretinib	Dec 30, 2040	New patent for this product

RETEVMO (CAPSULE) (ORAL) SELPERCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.: 213246  Prod. No.: 001 RX (40MG)

Patents	Expiration	Change
Pat. No. 10137124 Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): 001: Jun 5, 2020 Claim Types: Method of use Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate) Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2037	New Use Code
Pat. No. 10172851 Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): 001: Jun 5, 2020 Claim Types: Method of use Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate) Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2037	New Use Code
Pat. No. 10584124 DS* Crystalline forms Pat. Sub. Date(s): 001: Jun 5, 2020 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate) Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2038	New Use Code
Pat. No. 10786489 DP* Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-- diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-A]pyridine-3-carb- onitrile Pat. Sub. Date(s): 001: Oct 26, 2020 Claim Types: Formulation; Method of use Use Code: U-2971: The treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) Use Code: U-2972: The treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy Use Code: U-2973: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is papillary thyroid cancer Use Code: U-2974: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is medullary thyroid cancer Use Code: U-2975: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is differentiated thyroid cancer Use Code: U-2976: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is recurrent thyroid cancer Use Code: U-2977: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive refractory differentiated thyroid cancer who require systemic therapy and are radioactive iodine-refractory Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2038	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	May 29, 2027	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-484: Treatment of pediatric patients 2 years of age to less than 12 years of age with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy	May 29, 2031	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-485: Treatment of pediatric patients 2 years of age to less than 12 years of age with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)	May 29, 2031	New exclusivity for this product

RETEVMO (CAPSULE) (ORAL) SELPERCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.: 213246  Prod. No.: 002 RX (80MG)

Patents	Expiration	Change
Pat. No. 10137124 Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): 002: Jun 5, 2020 Claim Types: Method of use Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate) Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2037	New Use Code
Pat. No. 10172851 Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): 002: Jun 5, 2020 Claim Types: Method of use Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate) Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2037	New Use Code
Pat. No. 10584124 DS* Crystalline forms Pat. Sub. Date(s): 002: Jun 5, 2020 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-2826: Treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer Use Code: U-2827: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret-mutant medullary thyroid cancer (MTC) who require systemic therapy Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate) Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2038	New Use Code
Pat. No. 10786489 DP* Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-- diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-A]pyridine-3-carb- onitrile Pat. Sub. Date(s): 002: Oct 26, 2020 Claim Types: Formulation; Method of use Use Code: U-2971: The treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) Use Code: U-2972: The treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy Use Code: U-2973: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is papillary thyroid cancer Use Code: U-2974: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is medullary thyroid cancer Use Code: U-2975: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is differentiated thyroid cancer Use Code: U-2976: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory, wherein the cancer is recurrent thyroid cancer Use Code: U-2977: Treating adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive refractory differentiated thyroid cancer who require systemic therapy and are radioactive iodine-refractory Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2038	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	May 29, 2027	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-484: Treatment of pediatric patients 2 years of age to less than 12 years of age with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy	May 29, 2031	New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-485: Treatment of pediatric patients 2 years of age to less than 12 years of age with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)	May 29, 2031	New exclusivity for this product

RETEVMO (TABLET) (ORAL) SELPERCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.: 218160  Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (120MG); 004 RX (160MG)

Patents	Expiration	Change
Pat. No. 10137124 Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): All strengths: May 9, 2024 Claim Types: Method of use Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2037	New Use Code
Pat. No. 10172851 Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors Pat. Sub. Date(s): All strengths: May 9, 2024 Claim Types: Method of use Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3949: Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion that has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options Use Code: U-3950: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3951: Treatment of adult or pediatric patients 2 years of age or older with advanced or metastatic thyroid cancer with a ret gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory	Oct 10, 2037	New Use Code
Pat. No. 10584124 DS* DLR* Crystalline forms Pat. Sub. Date(s): All strengths: May 9, 2024 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options	Oct 10, 2038	New Delisting Request flag
Pat. No. 10786489 DP* DLR* Formulations of 6-(2-hydroxy-2-methylpropxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-- diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-A]pyridine-3-carb- onitrile Pat. Sub. Date(s): All strengths: May 9, 2024 Claim Types: Formulation; Method of use Use Code: U-3450: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test Use Code: U-3451: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy Use Code: U-3452: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory Use Code: U-3453: Treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options	Oct 10, 2038	New Delisting Request flag

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.: 211675  Prod. No.: 001 RX (15MG)

Patents	Expiration	Change
Pat. No. 8962629 DS* Tricyclic compounds Pat. Sub. Date(s): 001: Sep 13, 2019 Claim Types: Compound; Composition; Method of use Use Code: U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers Use Code: U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers Use Code: U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers Use Code: U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers Use Code: U-3624: Treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers Use Code: U-3945: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers Use Code: U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers	Jan 15, 2031	New Use Code
Pat. No. 11365198 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: Jul 20, 2022 Claim Types: Method of use Use Code: U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers Use Code: U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers	Oct 17, 2036	New Use Code
Pat. No. 11512092 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: Dec 16, 2022 Claim Types: Method of use Use Code: U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers Use Code: U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers Use Code: U-3487: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to one or more tnf blockers Use Code: U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers	Oct 17, 2036	New Use Code
Pat. No. 11773106 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: Nov 2, 2023 Claim Types: Method of use Use Code: U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers Use Code: U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers Use Code: U-3487: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to one or more tnf blockers Use Code: U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers	Oct 17, 2036	New Use Code
Pat. No. 11976077 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-α]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms therof Pat. Sub. Date(s): 001: Jun 5, 2024 Claim Types: Method of use Use Code: U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable	Oct 17, 2036	New patent for this product
Pat. No. 11993605 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: Jun 26, 2024 Claim Types: Method of use Use Code: U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers Use Code: U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers	Oct 17, 2036	New patent for this product
Pat. No. 11993606 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: Jun 26, 2024 Claim Types: Method of use Use Code: U-3487: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to one or more tnf blockers	Oct 17, 2036	New patent for this product

RINVOQ LQ (SOLUTION) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.: 218347  Prod. No.: 001 RX (1MG/ML)

Patents	Expiration	Change
Pat. No. 8962629 DS* Tricyclic compounds Pat. Sub. Date(s): 001: May 23, 2024 Claim Types: Compound; Composition; Method of use Use Code: U-3945: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers Use Code: U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers	Jan 15, 2031	New patent for this product
Pat. No. 9951080 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: May 23, 2024 Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process	Oct 17, 2036	New patent for this product
Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: May 23, 2024 Claim Types: New polymorph, salt or hydrate; Process; Composition	Oct 17, 2036	New patent for this product
Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: May 23, 2024 Claim Types: New polymorph, salt or hydrate; Process	Oct 17, 2036	New patent for this product
Pat. No. 11661425 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: May 23, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Oct 17, 2036	New patent for this product
Pat. No. 11680069 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: May 23, 2024 Claim Types: New polymorph, salt or hydrate; Composition; Process; Product-by-process	Oct 17, 2036	New patent for this product
Pat. No. 11718627 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: May 23, 2024 Claim Types: New polymorph, salt or hydrate; Composition	Oct 17, 2036	New patent for this product
Pat. No. 11773105 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]- pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof Pat. Sub. Date(s): 001: May 23, 2024 Claim Types: New polymorph, salt or hydrate	Oct 17, 2036	New patent for this product

RISVAN (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) RISPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: LABS FARMS ROVI SA      NDA No.: 214835  Prod. No.: 001 RX (75MG); 002 RX (100MG)

Patents	Expiration	Change
Pat. No. 11752094 Antipsychotic injectable depot composition Pat. Sub. Date(s): All strengths: Jun 10, 2024 Claim Types: Method of use Use Code: U-3942: Treatment of schizophrenia in adults by intramuscular administration of extended release injectable composition	May 31, 2031	New patent for this product

RYTELO (POWDER) (INTRAVENOUS) IMETELSTAT SODIUM
NDA Applicant: GERON      NDA No.: 217779  Prod. No.: 001 RX (EQ 47MG BASE/VIAL); 002 RX (EQ 188MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 7494982 DS* DP* Modified oligonucleotides for telomerase inhibition Pat. Sub. Date(s): All strengths: Jul 3, 2024 Claim Types: Compound; Composition	Dec 27, 2025	New product in Orange Book
Pat. No. 9375485 Use of telomerase inhibitors for the treatment of myeloproliferative disorders and myeloproliferative neoplasms Pat. Sub. Date(s): All strengths: Jul 3, 2024 Claim Types: Method of use Use Code: U-3956: Treatment of patients with myelodysplastic syndromes (MDS) with transfusion-dependent anemia	Mar 15, 2033	New product in Orange Book
Pat. No. 9388415 Modified oligonucleotides for telomerase inhibition Pat. Sub. Date(s): All strengths: Jul 3, 2024 Claim Types: Method of use Use Code: U-3956: Treatment of patients with myelodysplastic syndromes (MDS) with transfusion-dependent anemia	Sep 9, 2024	New product in Orange Book
Pat. No. 9388416 Modified oligonucleotides for telomerase inhibition Pat. Sub. Date(s): All strengths: Jul 3, 2024 Claim Types: Method of use Use Code: U-3956: Treatment of patients with myelodysplastic syndromes (MDS) with transfusion-dependent anemia	Sep 9, 2024	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-482: Treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA)	Jun 6, 2031	New product in Orange Book

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. 12013403 Compositions and methods for detection of SMN protein in a subject and treatment of a subject Pat. Sub. Date(s): 001: Jun 28, 2024 Claim Types: Method of use Use Code: U-1941: Treatment of infantile-onset spinal muscular atrophy Use Code: U-1942: Treatment of spinal muscular atrophy by increasing exon-7 inclusion in SMN2 mRNA Use Code: U-1943: Treatment of spinal muscular atrophy Use Code: U-1944: Treatment of spinal muscular atrophy by inhibiting an SMN2 pre-mRNA intronic splicing silencer site Use Code: U-2093: Treatment of type ii spinal muscular atrophy Use Code: U-2094: Treatment of type iii spinal muscular atrophy	Mar 4, 2036	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. 12005036 Methods of administering solriamfetol to lactating women Pat. Sub. Date(s): All strengths: Jun 13, 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

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. 11975012 Remdesivir treatment methods Pat. Sub. Date(s): 001: Jun 5, 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 expiration date. Was previously May 28, 2041
Pat. No. 11975017 DP* Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections Pat. Sub. Date(s): 001: Jun 5, 2024 Claim Types: Formulation claimed by its inherent performace characteristics	Jan 10, 2039 *PED	New expiration date. Was previously Jul 10, 2038

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. 11903953 Remdesivir treatment methods Pat. Sub. Date(s): 002: Mar 19, 2024 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. 11975012 Remdesivir treatment methods Pat. Sub. Date(s): 002: Jun 5, 2024 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 expiration date. Was previously May 28, 2041

VIGAFYDE (SOLUTION) (ORAL) VIGABATRIN
Drug Classes: antiepileptic drug (AED)
NDA Applicant: PYROS PHARMS      NDA No.: 217684  Prod. No.: 001 RX (100MG/ML)

Patents	Expiration	Change
Pat. No. 12016857 DP* Stable liquid vigabatrin pharmaceutical composition for oral dosage Pat. Sub. Date(s): 001: Jul 1, 2024 Claim Types: Formulation	Aug 16, 2039	New product in Orange Book

WEGOVY (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO      NDA No.: 215256  Prod. No.: 005 RX (2.4MG/0.75ML (2.4MG/0.75ML))

Patents	Expiration	Change
Pat. No. 12029779 Semaglutide in medical therapy Pat. Sub. Date(s): 005: Jul 9, 2024 Claim Types: Method of use Use Code: U-3162: Method for weight management	Oct 10, 2038	New patent for this product

XIGDUO XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: ASTRAZENECA AB      NDA No.: 205649  Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (10MG;500MG); 004 RX (10MG;1GM); 005 RX (2.5MG;1GM)

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Dec 12, 2027 PED	New exclusivity for this product

XYREM (SOLUTION) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: JAZZ PHARMS      NDA No.: 021196  Prod. No.: 001 RX (0.5GM/ML)

Patents	Expiration	Change
Pat. No. 11986446 Method Of Administration Of Gamma Hydroxybutyrate With Monocarboxylate Transporters Pat. Sub. Date(s): 001: Jun 18, 2024 Claim Types: Method of use Use Code: U-3324: Method of treating patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered	Mar 15, 2033	New patent for this product

XYWAV (SOLUTION) (ORAL) CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: JAZZ      NDA No.: 212690  Prod. No.: 001 RX (0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML)

Patents	Expiration	Change
Pat. No. 11986446 Method Of Administration Of Gamma Hydroxybutyrate With Monocarboxylate Transporters Pat. Sub. Date(s): 001: Jun 18, 2024 Claim Types: Method of use Use Code: U-3017: Method of treating excessive daytime sleepiness and/or cataplexy in narcolepsy patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered Use Code: U-3324: Method of treating patients with a salt of gamma-hydroxybutyrate when divalproex sodium is concomitantly administered	Mar 15, 2033	New patent for this product

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. 11992480 Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Pat. Sub. Date(s): 001: Jun 26, 2024 Claim Types: Method of improving a treatment Use Code: U-3748: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older	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): 001: Jul 9, 2024 Claim Types: Method of improving a treatment Use Code: U-3748: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older	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): 001: Jul 9, 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): 001: Jul 9, 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): 001: Jul 9, 2024 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	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. 11992480 Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Pat. Sub. Date(s): 001: Jun 26, 2024 Claim Types: Method of improving a treatment Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older	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): 001: Jul 10, 2024 Claim Types: Method of improving a treatment Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older	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): 001: Jul 10, 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): 001: Jul 10, 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): 001: Jul 10, 2024 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Jun 7, 2037	New patent for this product