Posted from: Friday, July 07, 2017 - 02:42 PM - Present

First Generic for Truvada

June 8, 2017 – The U.S. FDA has approved Teva Pharmaceutical’s generic for the 200mg/300mg strength of Truvada® (emtricitabine/tenofovir disoproxil fumarate) tablets, manufactured by Gilead Sciences. Other strengths of Truvada remain brand only. The drug is indicated for use in combination with other antiretroviral drugs to treat HIV-1 infections for adults and children who weigh 17kg (approximately 40 pounds) or more. Along with safe-sex practices and regular HIV testing, emtricitabine/tenofovir disoproxil fumarate is also FDA approved as pre-exposure prophylaxis (PrEP) for HIV-negative individuals who are at high risk of being infected.

As the first generic to be FDA approved, Teva’s product has 180 days of exclusivity. However, no launch or pricing plans have been announced. According to Gilead’s 2016 annual report, all strengths of Truvada accounted for U.S. sales of nearly $2.1 billion last year.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Monday, October 21, 2019 - 12:07 AM.