Details for New Drug Application (NDA): 212904
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NDA 212904 describes FOTIVDA, which is a drug marketed by Aveo Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the FOTIVDA profile page.
The generic ingredient in FOTIVDA is tivozanib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tivozanib hydrochloride profile page.
The generic ingredient in FOTIVDA is tivozanib hydrochloride. There is one drug master file entry for this compound. 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: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212904
Generic Entry Date for 212904*:
Constraining patent/regulatory exclusivity:
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 | 45629-089-02 | 1 BOTTLE, PLASTIC in 1 CARTON (45629-089-02) / 21 CAPSULE in 1 BOTTLE, PLASTIC |
| FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904 | NDA | AVEO Pharmaceuticals, Inc. | 45629-134 | 45629-134-02 | 1 BOTTLE, PLASTIC in 1 CARTON (45629-134-02) / 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: | 11,504,365 | 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: | 7,166,722 | Patent Expiration: | Nov 16, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 212904
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aveo Pharms | FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904-001 | Mar 10, 2021 | 6,821,987 | ⤷ Start Trial |
| Aveo Pharms | FOTIVDA | tivozanib hydrochloride | CAPSULE;ORAL | 212904-002 | Mar 10, 2021 | 6,821,987 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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