Details for New Drug Application (NDA): 212904
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The generic ingredient in FOTIVDA is tivozanib hydrochloride. One supplier is listed for this compound. Additional details are available on the tivozanib hydrochloride profile page.
Summary for 212904
Tradename: | FOTIVDA |
Applicant: | Aveo Pharms |
Ingredient: | tivozanib hydrochloride |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212904
Generic Entry Date for 212904*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 212904
Mechanism of Action | Tyrosine Kinase Inhibitors |
Suppliers and Packaging for NDA: 212904
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904 | NDA | AVEO Pharmaceuticals, Inc. | 45629-089 | 45629-089-01 | 24 BOTTLE, PLASTIC in 1 CARTON (45629-089-01) / 21 CAPSULE in 1 BOTTLE, PLASTIC |
FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904 | NDA | AVEO Pharmaceuticals, Inc. | 45629-134 | 45629-134-01 | 24 BOTTLE, PLASTIC in 1 CARTON (45629-134-01) / 21 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.89MG BASE | ||||
Approval Date: | Mar 10, 2021 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Mar 10, 2026 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 5, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ADULTS WITH MODERATE HEPATIC IMPAIRMENT AND RELAPSED OR REFRACTORY ADVANCED RENAL CELL CARCINOMA FOLLOWING TWO OR MORE PRIOR SYSTEMIC ANTI-CANCER THERAPIES WITH 1MG TIVOZANIB HCL ORALLY FOR 21 DAYS FOLLOWED BY NO DRUG FOR 7 DAYS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 26, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | A METHOD OF TREATING ADULTS WITH RELAPSED OR REFRACTORY ADVANCED RENAL CELL CARCINOMA FOLLOWING TWO OR MORE PRIOR SYSTEMIC THERAPIES BY INHIBITING THE ANGIOGENESIS OF BLOOD VESSELS WITH A VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITOR |
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