Tenofovir alafenamide - Generic Drug Details
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Recent Clinical Trials for tenofovir alafenamide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Pittsburgh | Phase 1 |
Kenya Medical Research Institute | Phase 1 |
Centre for the AIDS Programme of Research in South Africa | Phase 1 |
Generic filers with tentative approvals for TENOFOVIR ALAFENAMIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 25MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 25MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 25MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for tenofovir alafenamide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | TENOFOVIR ALAFENAMIDE | tenofovir alafenamide fumarate | TABLET;ORAL | 214226-001 | Mar 30, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |