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 |
|---|---|
| Thai Association for the Study of the Liver | PHASE4 |
| Ministry of Health, Thailand | PHASE4 |
| Phichit Provincial Public Health Office, Ministry of Public Health, Thailand (Host institution) | PHASE4 |
Generic filers with tentative approvals for TENOFOVIR ALAFENAMIDE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 25MG | TABLET;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | EQ 25MG BASE | TABLET;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | TENOFOVIR ALAFENAMIDE FUMARATE | tenofovir alafenamide fumarate | TABLET;ORAL | 213867-001 | Mar 21, 2024 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Lupin Ltd | TENOFOVIR ALAFENAMIDE | tenofovir alafenamide fumarate | TABLET;ORAL | 214226-001 | Mar 30, 2023 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Gilead Sciences Inc | VEMLIDY | tenofovir alafenamide fumarate | TABLET;ORAL | 208464-001 | Nov 10, 2016 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
