Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: NCE - New chemical entity | Sep 24, 2029 | New product in Orange Book |
BRYHALI (LOTION) (TOPICAL) HALOBETASOL PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: BAUSCH NDA No.: 209355 Prod. No.: 001 RX (0.01%)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12076403 DP* Pharmaceutical formulations containing corticosteroids for topical administration Pat. Sub. Date(s): 001: Sep 24, 2024 Claim Types: Formulation | Nov 2, 2031 | New patent for this product |
BYNFEZIA PEN (SOLUTION) (SUBCUTANEOUS) OCTREOTIDE ACETATE
Drug Classes: somatostatin analog
NDA Applicant: SUN PHARM NDA No.: 213224 Prod. No.: 001 RX (7MG/2.8ML (2.5MG/ML))
Patents | Expiration | Change |
---|---|---|
Pat. No. 10342850 DP* Octreotide injection Pat. Sub. Date(s): 001: Feb 10, 2020 Claim Types: Formulation | May 15, 2038 | New product in Orange Book |
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. 12090155 DP* Methods Pat. Sub. Date(s): 001: Oct 4, 2024 Claim Types: Method of use Use Code: U-4000: Treatment of depressive episodes or major depressive episodes associated with bipolar II disorder | Jul 7, 2040 | New patent for this product |
COMBOGESIC IV (SOLUTION) (INTRAVENOUS) ACETAMINOPHEN; IBUPROFEN SODIUM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HIKMA NDA No.: 215320 Prod. No.: 001 RX (1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML))
Patents | Expiration | Change |
---|---|---|
Pat. No. 12083087 Aqueous formulation comprising paracetamol and ibuprofen Pat. Sub. Date(s): 001: Oct 8, 2024 Claim Types: Method of use; Formulation Use Code: U-3744: Method of treating mild to moderate pain in adults Use Code: U-3745: Method of treating moderate to severe pain in adults as an adjunct to opioid analgesics | Jul 17, 2035 | New patent for this product |
DASATINIB (TABLET) (ORAL) DASATINIB [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: APOTEX NDA No.: 202103 Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (70MG); 004 RX (100MG)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: PC - Patent challenge | Mar 2, 2025 | New exclusivity for this product |
DASATINIB (TABLET) (ORAL) DASATINIB [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: APOTEX NDA No.: 203180 Prod. No.: 001 RX (80MG); 002 RX (140MG)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: PC - Patent challenge | Mar 2, 2025 | New exclusivity for this product |
DEXMEDETOMIDINE HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) DEXMEDETOMIDINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: SOMERSET NDA No.: 218112 Prod. No.: 001 RX (EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)); 002 RX (EQ 1MG BASE/10ML (EQ 100MCG BASE/ML))
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Mar 30, 2025 | New product in Orange Book |
DROSPIRENONE (TABLET, CHEWABLE) (ORAL) DROSPIRENONE
Drug Classes: progestin
NDA Applicant: EXELTIS USA INC NDA No.: 216285 Prod. No.: 001 DISC (3.5MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12090231 Synthetic progestogens and pharmaceutical compositions comprising the same Pat. Sub. Date(s): 001: Oct 9, 2024 Claim Types: Dosaage regimen Use Code: U-2553: Prevention of pregnancy in females of reproductive age | Jun 28, 2031 | New patent 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. 12076403 DP* Pharmaceutical formulations containing corticosteroids for topical administration Pat. Sub. Date(s): 001: Sep 24, 2024 Claim Types: Formulation | Nov 2, 2031 | New patent for this product |
ENVARSUS XR (TABLET, EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: VELOXIS PHARMS INC NDA No.: 206406 Prod. No.: 001 RX (EQ 0.75MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 4MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12083103 Tacrolimus for improved treatment of transplant patients Pat. Sub. Date(s): All strengths: Sep 12, 2024 Claim Types: Method of use; Formulation claimed by its inherent performace characteristics Use Code: U-2678: Prophylaxis of organ rejection in de novo transplant patient | May 30, 2028 | New patent for this product |
EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
NDA Applicant: JAZZ PHARMS RES NDA No.: 210365 Prod. No.: 001 RX (100MG/ML)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12064399 Use of cannabinoids in the treatment of epilepsy Pat. Sub. Date(s): 001: Sep 19, 2024 Claim Types: Method of use Use Code: U-3988: Use for the treatment of focal seizures associated with Lennox-Gastaut syndrome Use Code: U-3989: Use for the treatment of focal seizures associated with tuberous sclerosis complex | Jun 17, 2035 | New patent for this product |
FEMLYV (TABLET, ORALLY DISINTEGRATING) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: progestin
NDA Applicant: MILLICENT PR NDA No.: 218718 Prod. No.: 001 RX (0.02MG;1MG)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: NP - New product | Jul 22, 2027 | New exclusivity for this product |
FILSPARI (TABLET) (ORAL) SPARSENTAN
Drug Classes: endothelin and angiotensin II receptor antagonist
NDA Applicant: TRAVERE NDA No.: 216403 Prod. No.: 001 RX (200MG); 002 RX (400MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 9993461 Method for treating disorders associated with glomerular function Pat. Sub. Date(s): All strengths: Mar 14, 2023 Claim Types: Method of use Use Code: U-3269: Treatment of primary immunoglobulin a nephropathy (IGAN) in adults at risk of rapid disease progression Use Code: U-3993: Treatment of primary immunoglobulin a nephropathy (IGAN) in adults at risk for disease progression | Mar 29, 2030 | New Use Code |
Exclusivity | Expiration | Change |
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-493: To slow kidney function decline in adults with primary immunoglobulin a nephropathy (IGAN) who are at risk for disease progression, excluding the use provided for in the indication approved on february 17, 2023 | Sep 5, 2031 | New exclusivity for this product |
FUROSCIX (SOLUTION) (SUBCUTANEOUS) FUROSEMIDE
Drug Classes: loop diuretic
NDA Applicant: SCPHARMACEUTICALS NDA No.: 209988 Prod. No.: 001 RX (80MG/10ML (8MG/ML))
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: NP - New product | Oct 7, 2025 | New exclusivity for this product |
GEMTESA (TABLET) (ORAL) VIBEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: UROVANT NDA No.: 213006 Prod. No.: 001 RX (75MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12102638 Use Of Vibegron To Treat Overactive Bladder Pat. Sub. Date(s): 001: Oct 7, 2024 Claim Types: Method of use Use Code: U-3045: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency | Mar 22, 2040 | New patent for this product |
HYDROCORTISONE SODIUM SUCCINATE (INJECTABLE) (INJECTION) HYDROCORTISONE SODIUM SUCCINATE [GENERIC AP]
NDA Applicant: CIPLA NDA No.: 214050 Prod. No.: 001 RX (EQ 100MG BASE/VIAL)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Mar 25, 2025 | New exclusivity for this product |
IGALMI (FILM) (BUCCAL, SUBLINGUAL) DEXMEDETOMIDINE HYDROCHLORIDE
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: BIOXCEL NDA No.: 215390 Prod. No.: 001 RX (EQ 0.12MG BASE); 002 RX (EQ 0.18MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12090140 Non-sedating dexmedetomidine treatment regimens Pat. Sub. Date(s): All strengths: Sep 18, 2024 Claim Types: Method of use Use Code: U-3986: A method of treating agitation associated with schizophrenia or bipolar I or II disorder | Jan 12, 2043 | 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 11, 2025 | New expiration date. Was previously Jan 15, 2025 |
IZERVAY (SOLUTION) (INTRAVITREAL) AVACINCAPTAD PEGOL SODIUM
NDA Applicant: ASTELLAS NDA No.: 217225 Prod. No.: 001 RX (EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML))
Patents | Expiration | Change |
---|---|---|
Pat. No. 12016875 Methods for treating or preventing ophthalmological conditions Pat. Sub. Date(s): 001: Oct 1, 2024 Claim Types: Method of administration; Method of use Use Code: U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye | Jul 11, 2034 | 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 Use Code: U-3999: In combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence | 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 Use Code: U-3999: In combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence | 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 Use Code: U-3999: In combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence | Nov 9, 2031 | New Use Code |
Pat. No. 12064434 DP* Ribociclib tablet Pat. Sub. Date(s): 001: Sep 13, 2024 Claim Types: Formulation | Apr 14, 2036 | New patent for this product |
Exclusivity | Expiration | Change |
Exclusivity Code: I - New Indication: I-950: In combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence | Sep 17, 2027 | New exclusivity for this product |
KISQALI FEMARA CO-PACK (COPACKAGED) (TABLET) (ORAL) LETROZOLE; RIBOCICLIB SUCCINATE
Drug Classes: aromatase inhibitor == kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 209935 Prod. No.: 001 RX (2.5MG;EQ 200MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 8962630 Pyrrolopyrimidine compounds and their uses Pat. Sub. Date(s): 001: May 19, 2017 Claim Types: Method of use Use Code: U-2505: Treatment of pre/perimenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Use Code: U-3264: 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-3998: Adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence | Dec 9, 2029 | New Use Code |
Pat. No. 9416136 Pyrrolopyrimidine compounds and their uses Pat. Sub. Date(s): 001: May 19, 2017 Claim Types: Method of use Use Code: U-2505: Treatment of pre/perimenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Use Code: U-3264: 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-3998: Adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence | 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-2505: Treatment of pre/perimenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Use Code: U-3264: 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-3998: Adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence | Nov 9, 2031 | New Use Code |
Pat. No. 12064434 DP* Ribociclib tablet Pat. Sub. Date(s): 001: Sep 13, 2024 Claim Types: Formulation | Apr 14, 2036 | New patent for this product |
Exclusivity | Expiration | Change |
Exclusivity Code: I - New Indication: I-951: For the adjuvant treatment of adults with hormone receptor (hr)-positive, human epidermal growth factor receptor 2(her2)-negative stage ii and iii early breast cancer at high risk of recurrence | Sep 17, 2027 | New exclusivity for this product |
KORLYM (TABLET) (ORAL) MIFEPRISTONE [GENERIC AB]
Drug Classes: progestin antagonist
NDA Applicant: CORCEPT THERAP NDA No.: 202107 Prod. No.: 001 RX (300MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12097210 Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors Pat. Sub. Date(s): 001: Sep 25, 2024 Claim Types: Method of administration; Method of use Use Code: U-1643: Treating Cushing's syndrome | Jun 19, 2037 | New patent for this product |
LAZCLUZE (TABLET) (ORAL) LAZERTINIB MESYLATE
NDA Applicant: JANSSEN BIOTECH NDA No.: 219008 Prod. No.: 001 RX (EQ 80MG BASE); 002 RX (EQ 240MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 9593098 DS* DP* Compounds and compositions for modulating EGFR mutant kinase activities Pat. Sub. Date(s): All strengths: Sep 17, 2024 Claim Types: Compound; Method of use; Composition Use Code: U-3985: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with amivantamab | Oct 13, 2035 | New patent for this product |
Pat. No. 11453656 DS* DP* Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same Pat. Sub. Date(s): All strengths: Sep 17, 2024 Claim Types: New polymorph, salt or hydrate; Composition; Formulation | Apr 18, 2038 | New patent for this product |
Pat. No. 11850248 Therapies with 3rd generation EGFR tyrosine kinase inhibitors Pat. Sub. Date(s): All strengths: Sep 17, 2024 Claim Types: Method of use Use Code: U-3985: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with amivantamab | Aug 1, 2041 | New patent for this product |
Pat. No. 11879013 Combination therapies with bispecific anti-EGFR/c-Met antibodies and third generation EGFR tyrosine kinase inhibitors Pat. Sub. Date(s): All strengths: Sep 17, 2024 Claim Types: Method of use; Dosaage regimen Use Code: U-3985: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with amivantamab | May 21, 2040 | New patent for this product |
Pat. No. 11981659 Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same Pat. Sub. Date(s): All strengths: Sep 17, 2024 Claim Types: Method of use; New polymorph, salt or hydrate Use Code: U-3985: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with amivantamab | Apr 18, 2038 | New patent for this product |
Exclusivity | Expiration | Change |
Exclusivity Code: NCE - New chemical entity | Aug 19, 2029 | New exclusivity for this product |
LENVIMA (CAPSULE) (ORAL) LENVATINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: EISAI INC NDA No.: 206947 Prod. No.: 001 RX (EQ 4MG BASE); 002 RX (EQ 10MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12083112 Combination of a PD-1 antagonist and a VEGFR/FGFR/RET tyrosine kinase inhibitor for treating cancer Pat. Sub. Date(s): All strengths: Oct 3, 2024 Claim Types: Method of use; Method of administration; Kit Use Code: U-3996: First-line treatment of adults patients with advanced renal cell carcinoma by administering LENVIMA in combination with pembrolizumab Use Code: U-3997: Treatment of patients with PMMR/NOT MSI-H advanced endometrial carcinoma, have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation, by administering LENVIMA in combination with pembrolizumab | Mar 3, 2036 | New patent for this product |
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. 12076323 Treatment of hair loss disorders with deuterated JAK inhibitors Pat. Sub. Date(s): 001: Oct 1, 2024 Claim Types: Method of use; Method of administration Use Code: U-3976: Treatment of adult patients with alopecia areata | May 4, 2037 | New patent for this product |
Exclusivity | Expiration | Change |
Exclusivity Code: NCE - New chemical entity | Jul 25, 2029 | New exclusivity for this product |
LITFULO (CAPSULE) (ORAL) RITLECITINIB TOSYLATE
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER NDA No.: 215830 Prod. No.: 001 RX (EQ 50MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12077533 Pyrrolo[2,3-d]pyrimidinyl, pyrrolo[2,3-b]pyrazinyl and pyrrolo[2,3-d]pyridinyl acrylamides Pat. Sub. Date(s): 001: Oct 2, 2024 Claim Types: Method of use Use Code: U-3994: Method of treating severe alopecia areata in adults and adolescents 12 years and older by administering ritlectinib | Dec 3, 2034 | New patent for this product |
LIVDELZI (CAPSULE) (ORAL) SELADELPAR LYSINE
NDA Applicant: GILEAD SCIENCES INC NDA No.: 217899 Prod. No.: 001 RX (EQ 10MG BASE)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-486: Treatment of primary biliary cholangitis (PBC) in adults who have had an inadequate response to ursodeoxycholic acid (UDCA), or in patients unable to tolerate UDCA | Aug 14, 2031 | New exclusivity for this product |
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)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Mar 13, 2030 | New exclusivity for this product |
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Mar 13, 2031 | New exclusivity for this product |
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Sep 29, 2028 | New exclusivity for this product |
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-490: Treatment of cholestatic pruritas in patients 12 months of age to less than 5 years of age with progressive familial intrahepatic cholestasis (PFIC) | Jul 24, 2031 | New exclusivity for this product |
LOCAMETZ (POWDER) (INTRAVENOUS) GALLIUM GA-68 GOZETOTIDE
NDA Applicant: NOVARTIS NDA No.: 215841 Prod. No.: 001 RX (N/A)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12109277 Methods And Kits For Preparing Radionuclide Complexes Pat. Sub. Date(s): 001: Oct 8, 2024 Claim Types: Diagnostic or surgical method Use Code: U-4002: Positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer | Mar 9, 2036 | New patent for this product |
LUPKYNIS (CAPSULE) (ORAL) VOCLOSPORIN
Drug Classes: calcineurin-inhibitor immunosuppressant
NDA Applicant: AURINIA NDA No.: 213716 Prod. No.: 001 RX (7.9MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 7332472 DS* DP* Cyclosporine analogue mixtures and their use as immunomodulating agents Pat. Sub. Date(s): 001: Feb 11, 2021 Claim Types: Formulation; Method of use Use Code: U-3056: Treatment of patients with active lupus nephritis | Oct 17, 2025 | New expiration date. Was previously Oct 17, 2024 |
LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC NDA No.: 020517 Prod. No.: 003 RX (45MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 9617303 Sustained-release composition and method for producing the same Pat. Sub. Date(s): 003: Oct 4, 2024 Claim Types: Method of use Use Code: U-4001: Treatment of advanced prostatic cancer | Mar 22, 2028 | New patent for this product |
MAYZENT (TABLET) (ORAL) SIPONIMOD
Drug Classes: sphingosine 1-phosphate (S1P) receptor modulator
NDA Applicant: NOVARTIS NDA No.: 209884 Prod. No.: 001 RX (EQ 0.25MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 1MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12071402 DP* Immunosuppressant formulations Pat. Sub. Date(s): All strengths: Sep 26, 2024 Claim Types: Formulation | Jan 5, 2032 | New patent for this product |
MIPLYFFA (CAPSULE) (ORAL) ARIMOCLOMOL CITRATE
NDA Applicant: ZEVRA DENMARK NDA No.: 214927 Prod. No.: 001 RX (EQ 47MG BASE); 002 RX (EQ 62MG BASE); 003 RX (EQ 93MG BASE); 004 RX (EQ 124MG BASE)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: NCE - New chemical entity | Sep 20, 2029 | New product in Orange Book |
MYHIBBIN (SUSPENSION) (ORAL) MYCOPHENOLATE MOFETIL
NDA Applicant: AZURITY NDA No.: 216482 Prod. No.: 001 RX (200MG/ML)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12097284 DP* Mycophenolate oral suspension Pat. Sub. Date(s): 001: Sep 27, 2024 Claim Types: Formulation | Aug 16, 2039 | New patent for this product |
Pat. No. 12097285 DP* Mycophenolate oral suspension Pat. Sub. Date(s): 001: Sep 27, 2024 Claim Types: Formulation; Method of use Use Code: U-1752: Prophylaxis of organ rejection | Aug 16, 2039 | 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. 12097189 Pharmaceutical composition for modified release Pat. Sub. Date(s): All strengths: Oct 2, 2024 Claim Types: Method of use Use Code: U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency Use Code: U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more | Sep 28, 2029 | New patent for this product |
NALBUPHINE HYDROCHLORIDE (INJECTABLE) (INJECTION) NALBUPHINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist/antagonist
NDA Applicant: SOMERSET THERAPS LLC NDA No.: 216049 Prod. No.: 001 RX (10MG/ML); 002 RX (20MG/ML)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Mar 30, 2025 | New product in Orange Book |
NALBUPHINE HYDROCHLORIDE (INJECTABLE) (INJECTION) NALBUPHINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist/antagonist
NDA Applicant: SOMERSET THERAPS LLC NDA No.: 216050 Prod. No.: 001 RX (10MG/ML); 002 RX (20MG/ML)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Mar 24, 2025 | New product in Orange Book |
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (SOLUTION) (INTRAVENOUS) NOREPINEPHRINE BITARTRATE
Drug Classes: catecholamine
NDA Applicant: BAXTER HLTHCARE CORP NDA No.: 214313 Prod. No.: 001 RX (EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)); 002 RX (EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)); 003 RX (EQ 16MG BASE/250ML (EQ 64MCG BASE/ML))
Patents | Expiration | Change |
---|---|---|
Pat. No. 12097170 DP* Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation Pat. Sub. Date(s): All strengths: Sep 30, 2024 Claim Types: Drug in a container; Method of use Use Code: U-3995: To restore blood pressure in adult patients with acute hypotensive states | Mar 8, 2041 | New patent for this product |
ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 203496 Prod. No.: 001 RX (EQ 0.125MG BASE); 002 RX (EQ 0.25MG BASE); 003 RX (EQ 1MG BASE); 004 RX (EQ 2.5MG BASE); 005 RX (EQ 5MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): All strengths: Mar 28, 2017 Claim Types: Product-by-process | Dec 15, 2028 | New Delisting Request flag |
ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA NDA No.: 214621 Prod. No.: 001 RX (120MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12097198 Treatment of prostate cancer Pat. Sub. Date(s): 001: Sep 25, 2024 Claim Types: Method of use; Dosaage regimen Use Code: U-3020: Treatment of adult patients with advanced prostate cancer | Sep 29, 2037 | New patent for this product |
ORIAHNN (COPACKAGED) (CAPSULE) (ORAL) ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE NDA No.: 213388 Prod. No.: 001 RX (EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12083227 DP* Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Pat. Sub. Date(s): 001: Oct 8, 2024 Claim Types: Formulation; Method of use Use Code: U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) | Aug 20, 2038 | New patent for this product |
ORKAMBI (TABLET) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
NDA Applicant: VERTEX PHARMS INC NDA No.: 206038 Prod. No.: 001 RX (125MG;200MG); 002 RX (125MG;100MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): All strengths: Sep 18, 2024 Claim Types: Method of use Use Code: U-3984: Treatment of cystic fibrosis in patients aged 6 years and older who are homozygous for the F508DEL CFTR gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432 | Dec 4, 2028 | New patent for this product |
ORKAMBI (GRANULE) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
NDA Applicant: VERTEX PHARMS INC NDA No.: 211358 Prod. No.: 001 RX (125MG/PACKET;100MG/PACKET); 002 RX (188MG/PACKET;150MG/PACKET); 003 RX (94MG/PACKET;75MG/PACKET)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): All strengths: Sep 18, 2024 Claim Types: Method of use Use Code: U-3983: Treatment of cystic fibrosis in patients aged 1 year to 5 years who are homozygous for the F508DEL cftr gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432 | Dec 4, 2028 | New patent for this product |
PLENVU (FOR SOLUTION) (ORAL) ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
NDA Applicant: SALIX NDA No.: 209381 Prod. No.: 001 RX (7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12083179 DP* Colon cleansing compositions and method of use Pat. Sub. Date(s): 001: Sep 18, 2024 Claim Types: Formulation; Kit; Method of use Use Code: U-2310: For cleansing of the colon in preparation for colonoscopy in adults | Sep 10, 2033 | New patent for this product |
PREVYMIS (TABLET) (ORAL) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 209939 Prod. No.: 001 RX (240MG); 002 RX (480MG)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: NPP - New patient population | Aug 30, 2027 | New exclusivity for this product |
PREVYMIS (SOLUTION) (INTRAVENOUS) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 209940 Prod. No.: 001 RX (240MG/12ML (20MG/ML)); 002 RX (480MG/24ML (20MG/ML))
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: NPP - New patient population | Aug 30, 2027 | New exclusivity for this product |
PREVYMIS (PELLETS) (ORAL) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MSD NDA No.: 219104 Prod. No.: 001 RX (20MG/PACKET); 002 RX (120MG/PACKET)
Patents | Expiration | Change |
---|---|---|
Pat. No. RE46791 DS* DP* Substituted dihydroquinazolines Pat. Sub. Date(s): All strengths: Sep 25, 2024 Claim Types: Compound; Process; Composition; Method of use | Jan 18, 2029 | New patent for this product |
Exclusivity | Expiration | Change |
Exclusivity Code: NP - New product | Aug 30, 2027 | New exclusivity for this product |
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Jun 5, 2030 | New exclusivity for this product |
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Nov 8, 2024 | New exclusivity for this product |
PROTONIX IV (INJECTABLE) (INTRAVENOUS) PANTOPRAZOLE SODIUM [GENERIC AP]
Drug Classes: proton pump inhibitor
NDA Applicant: WYETH PHARMS NDA No.: 020988 Prod. No.: 001 RX (EQ 40MG BASE/VIAL)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: NPP - New patient population | Aug 12, 2027 | New exclusivity for this product |
PURIFIED CORTROPHIN GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: ANI PHARMS NDA No.: 008975 Prod. No.: 002 RX (80 UNITS/ML) NDA No.: 008975 Prod. No.: 001 DISC (40 UNITS/ML)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12102662 Methods For Storing And Warming Purified Corticotropin Compositions Pat. Sub. Date(s): All strengths: Oct 4, 2024 Claim Types: Process Use Code: U-3904: Acute exacerbations of multiple sclerosis Use Code: U-3905: Allergic conjunctivitis Use Code: U-3906: Anterior segment inflammation Use Code: U-3907: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: acute gouty arthritis Use Code: U-3908: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis Use Code: U-3909: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: juvenile rheumatoid arthritis Use Code: U-3910: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis Use Code: U-3911: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis Use Code: U-3912: Atopic dermatitis Use Code: U-3913: Chorioretinitis Use Code: U-3914: Diffuse posterior uveitis and choroiditis Use Code: U-3915: During an exacerbation or as maintenance therapy in selected cases of: systemic dermatomyositis (polymyositis) Use Code: U-3916: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus Use Code: U-3917: Iridocyclitis Use Code: U-3918: Iritis Use Code: U-3919: Keratitis Use Code: U-3920: Optic neuritis Use Code: U-3921: Serum sickness Use Code: U-3922: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa Use Code: U-3923: Severe erythema multiforme (stevens-johnson syndrome) Use Code: U-3924: Severe psoriasis Use Code: U-3925: Symptomatic sarcoidosis Use Code: U-3926: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus | Oct 27, 2043 | New patent for this product |
REMODULIN (INJECTABLE) (IV (INFUSION), SUBCUTANEOUS) TREPROSTINIL [GENERIC AP]
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 021272 Prod. No.: 001 RX (1MG/ML); 002 RX (2.5MG/ML); 003 RX (5MG/ML); 004 RX (10MG/ML); 005 RX (20MG/ML); 006 RX (0.1MG/ML); 007 RX (0.2MG/ML); 008 RX (0.4MG/ML)
Patents | Expiration | Change |
---|---|---|
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): 001: Mar 28, 2017; 002: Mar 28, 2017; 003: Mar 28, 2017; 004: Mar 28, 2017; 005: Aug 24, 2021; 006: Oct 20, 2023; 007: Oct 20, 2023; 008: Oct 20, 2023 Claim Types: Product-by-process | Dec 15, 2028 | New Delisting Request flag |
REMODULIN (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 208276 Prod. No.: 001 DISC (20MG/20ML (1MG/ML)); 002 DISC (50MG/20ML (2.5MG/ML)); 003 DISC (100MG/20ML (5MG/ML)); 004 DISC (200MG/20ML (10MG/ML))
Patents | Expiration | Change |
---|---|---|
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): 001: Nov 2, 2018; 002: Nov 2, 2018; 003: Nov 2, 2018; 004: Oct 1, 2018 Claim Types: Product-by-process | Dec 15, 2028 | New Delisting Request flag |
REYVOW (TABLET) (ORAL) LASMIDITAN SUCCINATE
NDA Applicant: ELI LILLY AND CO NDA No.: 211280 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12071423 DP* Processes and intermediate for the large-scale preparation of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide hemisuccinate, and preparation of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide acetate Pat. Sub. Date(s): All strengths: Sep 20, 2024 Claim Types: Formulation | Jul 6, 2040 | New patent for this product |
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE NDA No.: 211675 Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12077545 DP* 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): All strengths: Sep 27, 2024 Claim Types: Formulation | Oct 17, 2036 | New patent for this product |
RYALTRIS (SPRAY, METERED) (NASAL) MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE
Drug Classes: corticosteroid == H1 receptor antagonist == histamine-1 (H1) inhibitor == mast cell stabilizer
NDA Applicant: GLENMARK SPECLT NDA No.: 211746 Prod. No.: 001 RX (0.025MG/SPRAY;0.665MG/SPRAY)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12064442 Treatment of allergic rhinitis using a combination of mometasone and olopatadine Pat. Sub. Date(s): 001: Sep 12, 2024 Claim Types: Method of use Use Code: U-3297: Treatment of seasonal allergic rhinitis by nasaly administering a combination of olopatadine hydrochloride and mometasone furoate | Sep 4, 2034 | New patent for this product |
SLYND (TABLET) (ORAL) DROSPIRENONE [GENERIC AB]
Drug Classes: progestin
NDA Applicant: EXELTIS USA INC NDA No.: 211367 Prod. No.: 001 RX (4MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12090231 Synthetic progestogens and pharmaceutical compositions comprising the same Pat. Sub. Date(s): 001: Oct 9, 2024 Claim Types: Dosaage regimen Use Code: U-2553: Prevention of pregnancy in females of reproductive age | Jun 28, 2031 | New patent for this product |
SOFDRA (GEL, METERED) (TOPICAL) SOFPIRONIUM BROMIDE
NDA Applicant: BOTANIX SB NDA No.: 217347 Prod. No.: 001 RX (EQ 12.45% BASE (EQ 72MG BASE/ACTUATION))
Patents | Expiration | Change |
---|---|---|
Pat. No. 8147809 DS* DP* Soft anticholinergic esters Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Compound; Composition | Mar 26, 2027 | New patent for this product |
Pat. No. 11566000 DS* DP* Crystalline form of sofpironium bromide and preparation method thereof Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Formulation; Product-by-process | May 22, 2040 | New patent for this product |
Pat. No. 11584715 DS* DP* Crystalline form of sofpironium bromide and preparation method thereof Pat. Sub. Date(s): 001: Sep 26, 2024 Claim Types: Formulation; New polymorph, salt or hydrate; Product-by-process | May 22, 2040 | 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. 12090126 Methods of administering solriamfetol to lactating women Pat. Sub. Date(s): All strengths: Sep 27, 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 |
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. 12084449 Imidazotriazines and imidazopyrimidines as kinase inhibitors Pat. Sub. Date(s): All strengths: Oct 2, 2024 Claim Types: Method of use Use Code: U-2813: Use for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a mesenchymal-epithelial transition (MET) exon 14 skipping mutation | Nov 19, 2027 | New patent for this product |
TAZAROTENE (CREAM) (TOPICAL) TAZAROTENE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: PADAGIS ISRAEL NDA No.: 217075 Prod. No.: 001 RX (0.05%)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Mar 8, 2025 | New exclusivity for this product |
TEZRULY (SOLUTION) (ORAL) TERAZOSIN HYDROCHLORIDE
Drug Classes: alpha adrenergic blocker
NDA Applicant: NOVITIUM PHARMA NDA No.: 218139 Prod. No.: 001 DISC (EQ 1MG BASE/ML)
Patents | Expiration | Change |
---|---|---|
Pat. No. 11224572 DP* Stable oral liquid composition of terazosin Pat. Sub. Date(s): 001: Sep 24, 2024 Claim Types: Formulation; Method of use Use Code: U-3990: Treatment of hypertension in patients who are in need of a liquid composition of terazosin Use Code: U-3991: Treatment of symptomatic benign prostatic hyperplasia (BPH) in patients who are in need of a liquid composition of terazosin | Jan 18, 2042 | New patent for this product |
THEOPHYLLINE (TABLET, EXTENDED RELEASE) (ORAL) THEOPHYLLINE [GENERIC AB]
Drug Classes: methylxanthine
NDA Applicant: STRIDES PHARMA NDA No.: 215312 Prod. No.: 001 RX (300MG)
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Mar 26, 2025 | New exclusivity 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. 12070629 DP* Core stabilized microcapsules, method of their preparation and uses thereof Pat. Sub. Date(s): 001: Sep 18, 2024 Claim Types: Formulation; Method of use Use Code: U-3987: Topical treatment of acne | Dec 30, 2030 | New patent for this product |
TYVASO (SOLUTION) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 022387 Prod. No.: 001 RX (0.6MG/ML)
Patents | Expiration | Change |
---|---|---|
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): 001: Mar 28, 2017 Claim Types: Product-by-process | Dec 15, 2028 | New Delisting Request flag |
TYVASO DPI (POWDER) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 214324 Prod. No.: 001 RX (0.016MG/INH); 002 RX (0.032MG/INH); 003 RX (0.048MG/INH); 004 RX (0.064MG/INH)
Patents | Expiration | Change |
---|---|---|
Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Pat. Sub. Date(s): All strengths: Jun 17, 2022 Claim Types: Product-by-process | Dec 15, 2028 | New Delisting Request flag |
UBRELVY (TABLET) (ORAL) UBROGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE NDA No.: 211765 Prod. No.: 002 RX (100MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12070450 Treatment of migraine Pat. Sub. Date(s): 002: Sep 25, 2024 Claim Types: Method of use Use Code: U-3992: Acute treatment of migraine with or without aura in a patient undergoing treatment with a weak or moderate CYP3A4 inducer | Dec 22, 2041 | New patent for this product |
VEVYE (SOLUTION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: HARROW EYE NDA No.: 217469 Prod. No.: 001 RX (0.1%)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12059449 DP* Ophthalmic composition for treatment of dry eye disease Pat. Sub. Date(s): 001: Sep 11, 2024 Claim Types: Method of use; Method of improving a treatment Use Code: U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye). | Apr 1, 2042 | New patent for this product |
VOYDEYA (TABLET) (ORAL) DANICOPAN
NDA Applicant: ALEXION PHARMS INC NDA No.: 218037 Prod. No.: 001 RX (50MG); 002 RX (100MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12076319 Therapeutic regimens for treatment of paroxysmal nocturnal hemoglobinuria Pat. Sub. Date(s): All strengths: Sep 24, 2024 Claim Types: Method of use Use Code: U-3933: Treatment of extravascular hemolysis (evh) in adults with paroxysmal nocturnal hemoglobinuria (PNH) as add-on therapy to ravulizumab or eculizumab | Aug 2, 2038 | New patent for this product |
VYNDAMAX (CAPSULE) (ORAL) TAFAMIDIS
NDA Applicant: FOLDRX PHARMS NDA No.: 212161 Prod. No.: 001 RX (61MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 7214695 DS* DP* Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding Pat. Sub. Date(s): 001: May 30, 2019 Claim Types: Compound; Composition | Dec 19, 2025 | New expiration date. Was previously Dec 19, 2024 |
Pat. No. 7214696 Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding Pat. Sub. Date(s): 001: May 30, 2019 Claim Types: Method of use Use Code: U-2524: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) | Dec 19, 2025 | New expiration date. Was previously Dec 19, 2024 |
VYNDAQEL (CAPSULE) (ORAL) TAFAMIDIS MEGLUMINE
NDA Applicant: FOLDRX PHARMS NDA No.: 211996 Prod. No.: 001 RX (20MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 7214695 DS* DP* Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding Pat. Sub. Date(s): 001: May 30, 2019 Claim Types: Compound; Composition | Dec 19, 2025 | New expiration date. Was previously Dec 19, 2024 |
Pat. No. 7214696 Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding Pat. Sub. Date(s): 001: May 30, 2019 Claim Types: Method of use Use Code: U-2524: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) | Dec 19, 2025 | New expiration date. Was previously Dec 19, 2024 |
XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: OPTINOSE US INC NDA No.: 209022 Prod. No.: 001 RX (0.093MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12083270 Delivery device and method Pat. Sub. Date(s): 001: Oct 2, 2024 Claim Types: Method of administration Use Code: U-2133: Method of delivering fluticasone propionate to a nasal airway | Apr 4, 2031 | New patent for this product |
XOFLUZA (TABLET) (ORAL) BALOXAVIR MARBOXIL
Drug Classes: polymerase acidic (PA) endonuclease inhibitor
NDA Applicant: GENENTECH INC NDA No.: 210854 Prod. No.: 002 RX (40MG); 003 RX (80MG) NDA No.: 210854 Prod. No.: 001 DISC (20MG**)
Patents | Expiration | Change |
---|---|---|
Pat. No. 12064438 DP* Pharmaceutical preparation excellent in light stability and dissolution property Pat. Sub. Date(s): All strengths: Sep 16, 2024 Claim Types: Formulation | Oct 9, 2039 | New patent 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))
Patents | Expiration | Change |
---|---|---|
Pat. No. 8906847 DS* DP* Prodrug comprising a drug linker conjugate Pat. Sub. Date(s): All strengths: Sep 5, 2024 Claim Types: Prodrug Use Code: U-3982: Treatment of hypoparathyroidism in adults | Apr 30, 2031 | New patent for this product |
Pat. No. 11590207 Dosage regimen for a controlled-release PTH compound Pat. Sub. Date(s): All strengths: Sep 5, 2024 Claim Types: Method of use; Method of administration Use Code: U-3982: Treatment of hypoparathyroidism in adults | Sep 28, 2037 | New patent for this product |
Pat. No. 11759504 DP* PTH compounds with low peak-to-trough ratios Pat. Sub. Date(s): All strengths: Sep 5, 2024 Claim Types: Formulation | Sep 28, 2037 | New patent for this product |
Pat. No. 11857603 PTH compounds with low peak-to-trough ratios Pat. Sub. Date(s): All strengths: Sep 5, 2024 Claim Types: Method of use Use Code: U-3982: Treatment of hypoparathyroidism in adults | Sep 28, 2037 | New patent for this product |
Pat. No. 11890326 DS* DP* Controlled-release PTH compound Pat. Sub. Date(s): All strengths: Sep 5, 2024 Claim Types: Compound | Sep 28, 2037 | New patent for this product |
Pat. No. 11918628 DS* DP* Controlled-release PTH compound Pat. Sub. Date(s): All strengths: Sep 5, 2024 Claim Types: Compound; Formulation | Sep 28, 2037 | New patent for this product |
Exclusivity | Expiration | Change |
Exclusivity Code: NP - New product | Aug 9, 2027 | New exclusivity for this product |
ZOKINVY (CAPSULE) (ORAL) LONAFARNIB
Drug Classes: farnesyltransferase inhibitor
NDA Applicant: SENTYNL THERAPS INC NDA No.: 213969 Prod. No.: 001 RX (50MG); 002 RX (75MG)
Patents | Expiration | Change |
---|---|---|
Pat. No. 7838531 Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis Pat. Sub. Date(s): All strengths: Feb 24, 2021 Claim Types: Method of use Use Code: U-3070: Reducing the risk of mortality in Hutchinson-Gilford progeria syndrome (HGPS) | Jul 26, 2025 | New expiration date. Was previously Jul 26, 2024 |
Pat. No. 8828356 Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis Pat. Sub. Date(s): All strengths: Feb 24, 2021 Claim Types: Method of use Use Code: U-3070: Reducing the risk of mortality in Hutchinson-Gilford progeria syndrome (HGPS) | Oct 17, 2025 | New expiration date. Was previously Oct 17, 2024 |
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))
Exclusivity | Expiration | Change |
---|---|---|
Exclusivity Code: NP - New product | Aug 7, 2027 | New exclusivity for this product |