For the full year 2021, Ocaliva had net sales of $363.5 million, which included net sales of US$260.8 million, representing an increase of 16% over the prior year.
For the full year 2021, Ocaliva had net sales of $363.5 million, which included net sales of US$260.8 million, representing an increase of 16% over the prior year.
Intercept Pharmaceuticals Inc. says it has entered into an agreement with Dr. Reddy’s Laboratories, which resolves a previously disclosed patent lawsuit, to market a generic version of Ocaliva (obeticholic acid) 5 mg and 10 mg tablets in the United States .
Ocaliva is used to treat a rare, chronic liver disease known as primary cholangitis (PBC).
“Under the terms of the agreement, Intercept grants Dr Reddy’s a non-exclusive, non-sub-licensable, non-exclusive, non-exclusive, non-sub-licensable, non-exclusive license to commercialize its generic version of Ocaliva in the United States beginning on or before October 26, 2035. Provided a transferable, royalty-free license under certain circumstances,” said Intercept Pharmaceuticals in a regulatory filing.
The company had previously disclosed similar patent petitions against five other ANDA (abbreviated New Drug Application) filers, seeking approval to bring generic Ocaliva to market, are pending, it further said.
For the full year 2021, Ocaliva net sales were $363.5 million, which included net sales of $260.8 million from the USA, an increase of 16% over the prior year.
In May 2020, Dr Reddy’s said that it has launched the generic version of Ocaliva in the Indian market.