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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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.