Viread is among the bigger pharmaceutical drugs in the US and has sales of around $725 mln (Rs 4,650 cr) in the US every year.
The patent for the drug expired on January 25. However, the companies had secured approval from the US FDA for their generic versions even before the patents expired under the FDA’s ‘tentative approval’ scheme.
The drug is also covered under U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program and qualified for expedited review by the drug regulator.
Tenofovir Disoproxi Fumarate Tablets is also indicated for the treatment of chronic hepatitis B in adults.
The two Indian companies are among the first wave of manufacturers launching the product in the US market.
The drug, also known as Tenofovir Disoproxi Fumarate, is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients 12 years of age and older.
“Cipla is excited to add this important antiretroviral product to its growing portfolio of ARVs in the US,” the company said.
Strides Shasun said its drug will be manufactured at the company’s oral dosage facility at Bangalore and will be marketed by Strides Pharma Inc. in the US Market.