Ranbaxy files with FDA over zidovudine (ZDV)

Another patent issue is illustrated by Ranbaxy's application to the FDA for approval for its version of zidovudine [zdv; RETROVIR]. Ranbaxy's application is related to its proposed use of zidovudine OUTSIDE OF the United States, although to be distributed by US-backed agencies. The presence of US patents forecloses this distribution in the United States.

Reuters:

India's Ranbaxy Laboratories Ltd. said on October 29, 2004 it had filed an application with the U.S. Food and Drug Administration for approval of its anti-retroviral drug zidovudine tablets used to treat AIDS. [Zidovudine is the generic name for Retrovir, manufactured by GlaxoSmithKline, which was the first drug approved for the treatment of HIV, in 1987. It is in a category of HIV medications called nucleoside reverse transcriptase inhibitors (NRTIs). Retrovir prevents HIV from altering the genetic material of healthy T-cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.]

The U.S. government has so far refused to buy generic AIDS drugs under its $15 billion emergency AIDS plan, saying that the FDA and not the World Health Organisation (WHO) should assess the quality of medicines.

If it gets approval, Ranbaxy's drugs could be distributed by U.S.-backed agencies in Africa and other poor countries. But they would not be sold in the United States, due to patent protection.

The WHO had removed three Ranbaxy-made generic AIDS drugs from its approved list in August, amid concerns over their safety after finding that the independent laboratory used by Ranbaxy to prove they were equivalent to brand-name drugs did not meet international standards.