The US Food & Drug Administration (FDA) has approved the first generic version of Truvada (emitricitabine/tenofovir disoproxil fumarate), a medication used in the treatment and prevention of HIV infection. Gilead Science's branded drug Truvada is a combination of the antiretroviral drugs Emtriva (emtricitabine) and Viread (tenofovir). Approval for generic emitricitabine and tenofovir disoproxil fumarate tablets in 200mg and 300mg dosages was granted to Teva Pharmaceuticals, one of the largest generic pharmaceutical firms.

Emtricitabine and tenofovir are antiviral medications used to prevent the HIV cells from multiplying in the body. Truvada is indicated for treatment of HIV-1 and in combination with other antiretroviral agents. It may also be used for in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of HIV transmission in high-risk adults who are HIV-negative. The medication may also be used to treat children with HIV who weigh at least 17kg. There are more than one million people in the US living with HIV, according to figures from the Centers for Disease Control and Prevention. 

Gilead told HIV/AIDS news outlet POZ that the patent for tenofovir disoproxil fumarate expires in July 2017 and the company retains exclusive rights for pediatric use of the drug until January next year. The patent for the other active ingredient emtricitabine does not run out until 2021. Gilead asserted the generic version of Truvada will not be immediately available in pharmacies. 

Speaking to POZ, Tim Horn, deputy executive director of HIV and HCV programs at Treatment Action Group, said: "It's not uncommon in patent settlement agreements for generics to negotiate language permitting full approvals months and years in advance of the settlement license date… Regardless, now is the time to start thinking seriously about the advantages, as well as the drawbacks, of generic products to prevent and treat HIV."

Generic medications account for an estimated nine out of ten prescriptions in the United States. They are identical to the branded drugs in the form of dosage, safety, strength, route of administration, quality, performance characteristics and intended use. They usually come to market once the patent on the branded drug has expired and are often significantly cheaper. The FDA Approved Drug Products search tool allows patients to discover if a generic version of their medication is available. Alternatively, ModRN Health returns a list of both generic and branded options when patients search for a medication.

For more information on Truvada, visit the link below: 

http://www.truvada.com/