FDAnews
www.fdanews.com/articles/197117-gilead-licenses-five-generic-drugmakers-to-produce-remdesivir

Gilead Licenses Five Generic Drugmakers to Produce Remdesivir

May 13, 2020

To make remdesivir available to COVID-19 patients in low-income nations, Gilead Sciences has signed non-exclusive licensing agreements with five generic drugmakers to allow them to manufacture and sell the antiviral.

Under the agreements, Gilead can set its own prices for the remdesivir it produces. Also, the companies will receive a technology transfer of Gilead’s manufacturing process so they can scale up production quickly in India and Pakistan.

The licenses are royalty-free until the World Health Organization declares the end of the COVID-19 pandemic or until another COVID-19 treatment is approved that is not a vaccine.

The companies that signed agreements are Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan. The companies will be allowed to distribute remdesivir to 127 countries that are mostly low-income or lower-middle income.

In the U.S., the FDA granted remdesivir Emergency Use Authorization earlier this month based on the results of at least two positive clinical trials (DID, May 4). — Jordan Williams