Posted from: Tuesday, January 16, 2018 - 12:49 PM - Present

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.

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 Friday, May 25, 2018 - 07:19 AM.