About tenofovir alafenamide
Tenofovir alafenamide manufacturers include the originator Gilead Sciences and Indian generic producers that make TAF under licence for low- and middle-income countries. Tenofovir alafenamide (TAF) is a prodrug of tenofovir that delivers the drug into cells at a much lower dose than the older tenofovir disoproxil fumarate (TDF). It is used for chronic hepatitis B and, in combinations, for HIV treatment and prevention. Pharmaceutical companies can source TAF tablets, combination products and API through out-licensing, supply or technology transfer.
Tenofovir alafenamide key facts
|
Property |
Tenofovir alafenamide |
|---|---|
|
INN |
Tenofovir alafenamide (as fumarate) |
|
Molecular formula / weight |
C21H29N6O5P / 476.5 g/mol (base) |
|
ATC code |
J05AF13 |
|
Drug class |
Nucleotide reverse transcriptase inhibitor (NtRTI) |
|
Brand names |
Vemlidy (hepatitis B); in Descovy, Odefsey, Genvoya, Biktarvy and Symtuza (HIV) |
|
Originator |
Gilead Sciences |
|
Dosage form and strength |
Tablets 25 mg (Vemlidy); 10 or 25 mg in HIV combinations |
|
Indications |
Chronic hepatitis B (Vemlidy); HIV-1 treatment and pre-exposure prophylaxis (in combinations) |
|
First approval |
Genvoya (first TAF product), FDA, 2015; Vemlidy, FDA, November 2016 |
|
US patent settlement |
Generic entry licensed from 31 October 2031 (Descovy, Vemlidy) and 31 January 2032 (Odefsey) |
|
EU patent expiry |
2027 (per Gilead) |
|
LMIC access |
Licensed through the Medicines Patent Pool for generic production in eligible countries |
Tenofovir alafenamide manufacturers and licensing history
Gilead developed TAF as a successor to tenofovir disoproxil fumarate (TDF). Because it delivers tenofovir more efficiently into cells, much lower doses are needed, with less effect on kidneys and bones. Genvoya was the first TAF-based product, approved in 2015, followed by Descovy, Odefsey, Vemlidy for hepatitis B in November 2016, and Biktarvy in 2018.
In September 2022, Gilead settled US patent litigation with Lupin, Apotex, Macleods, Hetero and Cipla. These companies received licences to sell generic Descovy and Vemlidy from 31 October 2031, and Odefsey from 31 January 2032, or earlier in certain circumstances. In January 2026, Cipla filed a 505(b)(2) application for emtricitabine/TAF referencing Descovy, and Gilead sued in February 2026.
For low- and middle-income countries, Gilead licensed TAF through the Medicines Patent Pool, and Indian companies produce generic TAF products for those markets. Buyers should confirm GMP status, a DMF and the territory covered by any licence.
Tenofovir alafenamide dosage forms and dossier types
TAF is approved as 25 mg tablets for hepatitis B and in several HIV combination tablets.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
TAF tablets |
25 mg |
US ANDA (from 2031); EU CTD; WHO PQ |
Reference Vemlidy; hepatitis B |
|
Emtricitabine / TAF tablets |
200/25 mg; 200/10 mg |
US ANDA; EU CTD; WHO PQ |
Reference Descovy |
|
TAF fumarate API |
Bulk |
US DMF; EU ASMF |
Polymorph and salt form are critical |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
ANDA (eCTD) |
Settlement dates from October 2031 |
|
European Union |
EU CTD |
Patent expiry 2027 per Gilead; check SPCs |
|
Low- and middle-income countries |
WHO PQ; national CTD |
Medicines Patent Pool licence territory |
Tenofovir alafenamide regulatory and patent status
TAF was first approved in Genvoya in 2015 and as Vemlidy in November 2016. In the US, settlements allow generic Descovy and Vemlidy from 31 October 2031 and Odefsey from 31 January 2032. Gilead reports EU patent expiry in 2027. In low- and middle-income countries, generic TAF is available under the Medicines Patent Pool licence.
Tenofovir alafenamide mechanism of action and therapeutic use
TAF is converted inside cells to tenofovir diphosphate, which blocks the reverse transcriptase enzyme of HIV and the polymerase of hepatitis B virus. Compared with TDF, it reaches higher levels in cells with much lower levels in the blood. TAF is used alone for chronic hepatitis B and in combinations for HIV treatment and prevention.
Tenofovir alafenamide licensing and sourcing
TAF suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or API supply. Buyers usually compare GMP status, WHO prequalification, licence territory and patent position. Current offers and supplier contacts are listed among the tenofovir alafenamide manufacturers on Pipelinepharma.
Frequently asked questions about tenofovir alafenamide
Who are the main tenofovir alafenamide manufacturers? Gilead Sciences is the originator. Indian generic companies make TAF products under the Medicines Patent Pool licence for low- and middle-income countries.
What is the difference between TAF and TDF? Both are prodrugs of tenofovir. TAF works at a much lower dose and has less effect on kidneys and bones than tenofovir disoproxil fumarate (TDF).
When can generic TAF launch in the US? Under settlements, generic Descovy and Vemlidy can launch from 31 October 2031, and Odefsey from 31 January 2032, or earlier in certain circumstances.
What forms and strengths of tenofovir alafenamide are available? TAF is available as 25 mg tablets (Vemlidy) and in HIV combinations at 10 or 25 mg.
What is tenofovir alafenamide used for? TAF is used alone for chronic hepatitis B and in combination products for HIV treatment and prevention.
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