Intercept Pharmaceuticals Inc has said it entered into a settlement agreement with Dr Reddy's Laboratories resolving the previously disclosed patent litigation to market a generic version of Ocaliva (obeticholic acid) 5 mg and 10 mg tablets in the USA.
Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC).
"Under the terms of the agreement, Intercept granted Dr. Reddy's a non-exclusive, non-sublicensable, non-transferable, royalty-free licence to commercialise its generic version of Ocaliva in the United States commencing on October 26, 2035, or earlier under certain circumstances," Intercept Pharmaceuticals in a regulatory filing said.
Similar patent litigation previously disclosed by the company against five other ANDA (Abbreviated New Drug Application) filers seeking approval to market generic Ocaliva remains pending, it further said.
For the full year 2021, Ocaliva net sales were USD 363.5 million including USA net sales of USD 260.8 million, which represented growth of 16 percent as compared to the prior year. In May 2020, Dr Reddy's said it has launched the generic version of Ocaliva in the Indian market.
(Edited by : Sangam Singh)
First Published: Aug 19, 2022 12:41 PM IST
Check out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!
BJP is planning to ban RSS, says Shiv Sena (UBT) chief Uddhav Thackeray
May 18, 2024 8:01 PM
Punjab Lok Sabha elections: Complete list of Congress candidates
May 18, 2024 4:08 PM
Punjab Lok Sabha elections: Check full list of AAP candidates and constituencies
May 18, 2024 12:59 PM
PM Modi, Rahul Gandhi election rallies in Delhi today: Here are the routes to avoid
May 18, 2024 11:28 AM