Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis (PBC)
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 $363.5 million including USA net sales of $260.8 million, which represented growth of 16 per cent 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.