Details for New Drug Application (NDA): 208464
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The generic ingredient in VEMLIDY is tenofovir alafenamide fumarate. There are forty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tenofovir alafenamide fumarate profile page.
Summary for 208464
Tradename: | VEMLIDY |
Applicant: | Gilead Sciences Inc |
Ingredient: | tenofovir alafenamide fumarate |
Patents: | 3 |
Pharmacology for NDA: 208464
Mechanism of Action | Nucleoside Reverse Transcriptase Inhibitors |
Suppliers and Packaging for NDA: 208464
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464 | NDA | Gilead Sciences, Inc. | 61958-2301 | 61958-2301-1 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Nov 10, 2016 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Oct 17, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 208464
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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