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Last Updated: April 14, 2026

Tenofovir alafenamide - Generic Drug Details


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Recent Clinical Trials for tenofovir alafenamide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Thai Association for the Study of the LiverPHASE4
Ministry of Health, ThailandPHASE4
Phichit Provincial Public Health Office, Ministry of Public Health, Thailand (Host institution)PHASE4

See all tenofovir alafenamide clinical trials

Generic filers with tentative approvals for TENOFOVIR ALAFENAMIDE
Applicant Application No. Strength Dosage Form
⤷  Start Trial⤷  Start Trial25MGTABLET;ORAL
⤷  Start Trial⤷  Start TrialEQ 25MG BASETABLET;ORAL
⤷  Start Trial⤷  Start Trial25MGTABLET;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

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