Thailand's FDA Registers Generic Version Of Abbott's Antiretroviral Aluvia For Use Under Compulsory Licensing Program

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Oct 2007 - 12:00 PDT

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Thailand's Food and Drug Administration on Tuesday completed the registration of a generic version of Abbott Laboratories' antiretroviral drug Aluvia for use under the country's compulsory licensing program, the Bangkok Post reports. The generic version is manufactured by Indian pharmaceutical company Matrix Laboratories (Apiradee, Bangkok Post, 10/17). The Thai Ministry of Public Health in June confirmed that it would continue with its plan to issue a compulsory license for the drug after Abbott and the health ministry could not reach a price agreement during negotiations.

The Thai government in January issued a compulsory license to produce a lower-cost version of Abbott's Kaletra. The drug company in May offered to sell Aluvia, an updated version of Kaletra, at a reduced price in Thailand on the condition that the country agreed not to allow generic versions of the drug into the market, Siriwat Thiptaradol, secretary-general of the Thai FDA, said. Abbott offered to sell Aluvia for about 34,000 baht, or $1,000, per person annually. Matrix offered to sell a generic version of Aluvia to Thailand for 24,324 baht, or $695, per person annually (Kaiser Daily HIV/AIDS Report, 6/7).

Vichai Chokewiwat, chair of the Government Pharmaceutical Organization and the health ministry's Committee on Compulsory Licensing, said GPO soon will import the first shipment of the generic version of Aluvia from Matrix. According to Siriwat, the registration process took more than three months to complete. The shipment from Matrix will include enough doses of the drug for 8,000 people during the next six months, the Post reports (Bangkok Post, 10/17).

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