About adefovir
Adefovir manufacturers include the originator Gilead Sciences (Hepsera), US generic makers Sigmapharm and Apotex, and more than 30 Chinese companies. Adefovir dipivoxil is an oral prodrug of adefovir, a nucleotide analogue that blocks hepatitis B virus replication. Pharmaceutical companies can source adefovir dipivoxil 10 mg tablets through out-licensing, supply or technology transfer. Dossiers are available in US ANDA, Chinese and CTD formats.
Adefovir key facts
| Property | Adefovir |
|---|---|
| INN | Adefovir (as adefovir dipivoxil) |
| Molecular formula / weight | C20H32N5O8P / 501.5 g/mol (dipivoxil) |
| CAS number | 142340-99-6 (adefovir dipivoxil) |
| ATC code | J05AF08 |
| Drug class | Nucleotide analogue reverse transcriptase inhibitor (antiviral) |
| Brand names | Hepsera (US, EU, China); Daiding and others (China) |
| Originator | Gilead Sciences (US); GSK held rights in Asia and Latin America |
| Dosage forms and strengths | Tablets 10 mg; capsules 10 mg (China) |
| Indications | Chronic hepatitis B in adults |
| First approval | US FDA, 20 September 2002 (NDA 021449) |
| EU approval | 6 March 2003 (centralised); withdrawn 31 December 2022 for commercial reasons |
| China | Daiding launched May 2005; GSK’s Hepsera September 2005; more than 30 companies now approved |
| US generic status | Sigmapharm, 29 August 2013 (now the US reference standard); Apotex, 6 July 2018 |
| Patent status | Core compound patents expired |
Adefovir manufacturers and licensing history
Adefovir was developed into a hepatitis B treatment by Gilead Sciences. In 2002, GSK licensed the rights to market adefovir dipivoxil in China, Japan, Korea, Taiwan and other Asian and Latin American markets.
The FDA approved Gilead’s Hepsera on 20 September 2002. Hepsera is now discontinued in the US, where Sigmapharm’s generic, approved on 29 August 2013, serves as the reference standard. Apotex received US approval on 6 July 2018.
China became the largest adefovir market. Tianjin Institute of Pharmaceutical Research launched Daiding tablets in May 2005, before GSK’s Hepsera arrived in September 2005. By 2014, GSK Tianjin, United Laboratories, Fujian Cosunter and Chia Tai Tianqing held most of the market. More than 30 Chinese companies now hold approvals, and more than 20 hold active CDE API registrations.
Buyers should confirm GMP status, a US DMF or CDE API registration, and crystalline-form data before choosing a dossier partner.
Adefovir dosage forms and dossier types
Adefovir dipivoxil is approved as 10 mg tablets, and capsules are also marketed in China. Generic adefovir manufacturers most often develop 10 mg tablets, because tablets are the reference form in the US and China.
| Form | Strengths | Typical dossier | Notes |
|---|---|---|---|
| Adefovir dipivoxil tablets | 10 mg | US ANDA; China NMPA; CTD | Main form for licensing; US reference standard Sigmapharm |
| Adefovir dipivoxil capsules | 10 mg | China NMPA | China only |
| Adefovir dipivoxil API | Bulk | US DMF; CDE API registration | Several crystalline forms; check patent status per country |
| Target market | Dossier format | Key requirement |
|---|---|---|
| United States | ANDA (eCTD) | Bioequivalence to the Sigmapharm reference standard |
| European Union | EU CTD | Hepsera withdrawn in 2022; confirm reference product availability per country |
| China | NMPA (CTD-based) | Reference Hepsera; volume-based procurement pricing |
| ASEAN, Latin America, other | ACTD / CTD | Reference to US or Chinese approval; zone IVb stability where required |
Adefovir regulatory and patent status
The FDA approved Hepsera under NDA 021449 on 20 September 2002. The EU granted a centralised authorisation on 6 March 2003, made unlimited in 2008. At Gilead’s request, the European Commission withdrew it on 31 December 2022 for commercial reasons.
US generic adefovir dipivoxil 10 mg tablets were first approved in August 2013. In China, Hepsera entered in September 2005, and domestic generics compete widely. Core compound patents have expired. Some crystalline-form patents have been litigated in China, so check national patent registers before filing.
Adefovir mechanism of action and therapeutic use
Adefovir dipivoxil is converted in the body to adefovir, which is phosphorylated to adefovir diphosphate. This active form inhibits the hepatitis B virus DNA polymerase and stops viral replication. Adefovir is approved for chronic hepatitis B in adults. Current guidelines prefer entecavir or tenofovir, which have a higher barrier to resistance.
Adefovir licensing and sourcing
Adefovir suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA or WHO GMP), dossier format and readiness, API source and territory availability. Current offers and supplier contacts are listed among the adefovir manufacturers on Pipelinepharma, including 10 mg tablet dossiers from China.
Frequently asked questions about adefovir
Who are the main adefovir manufacturers?
Gilead Sciences is the originator of Hepsera, and GSK marketed it in Asia. In the US, Sigmapharm and Apotex hold generic approvals. In China, more than 30 companies hold approvals, including Chia Tai Tianqing, United Laboratories and Fujian Cosunter.
Which countries produce adefovir API and finished dosage forms?
China is the largest producer of adefovir API and finished tablets, with more than 20 active API registrations at CDE. India and North America also supply finished products for the US market.
Is Hepsera still approved in the EU?
No. The European Commission withdrew Hepsera’s EU authorisation on 31 December 2022, at Gilead’s request, for commercial reasons. Buyers planning EU filings should confirm reference product availability in each target country.
Is there a generic version of adefovir?
Yes. Sigmapharm received the first US generic approval in August 2013, and Apotex followed in 2018. In China, generics have been available since 2005, and more than 30 companies now hold approvals.
What forms and strengths of adefovir are available?
Adefovir dipivoxil is available as 10 mg tablets in the US, EU and China. China also has 10 mg capsules.
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