Generic Launched for Viread
December 15, 2017 – Teva Pharmaceuticals has announced the launch of its generic for Gilead’s Viread® (tenofovir disoproxil fumarate) 300mg tablets. The drug is approved to treat HIV-1 in adults and pediatric patients at least two years of age, as well as chronic hepatitis B in adults and children who are at least 12 years old. It should be used in combination with other antiretroviral agents when treating HIV.
According to a press release from Teva, an estimated 1.1 million Americans have HIV, while estimates for those infected with chronic hepatitis B are anywhere from 850,000 to 2.2 million. Tenofovir disoproxil fumarate is considered both a nucleotide analog HIV-1 reverse transcriptase inhibitor, and a hepatitis B virus (HBV) reverse transcriptase inhibitor. It works by interfering with each virus’s ability to replicate in the body. Recommended dosing is based on several factors, including age, indication, and the patient’s renal health. The drug carries a black box warning for post-treatment exacerbation of hepatitis. Patients with hepatitis B who discontinue anti-hepatitis B therapy, such as tenofovir disoproxil fumarate, should have their hepatic function closely monitored.
Due to a patent settlement, Teva currently holds exclusivity for its Viread generic. Total annual sales of brand name Viread had reached $762 million as of October 2017, according to IMS. Additional generics for the drug are expected to launch in late January of 2018, including generics for its 150mg, 200mg, and 250mg tablet dosage forms.
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- 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
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