In order to offer generic versions of Ocaliva (obeticholic acid) 5 mg and 10 mg tablets in the USA, Intercept Pharmaceuticals Inc. has announced that it has reached a settlement agreement with Dr Reddy's Laboratories, ending the existing patent litigation.
Primary biliary cholangitis, an uncommon, chronic liver condition, is treated with ocaliva (PBC).
Intercept Pharmaceuticals stated in a regulatory filing that it has awarded Dr. Reddy's a non-exclusive, non-sublicensable, non-transferable, royalty-free licence to market its generic version of Ocaliva in the United States starting on October 26, 2035, or sooner under specific conditions.
The company previously reported similar patent litigation underway against five more ANDA (Abbreviated New Drug Application) applicants requesting authorization to market generic Ocaliva.
Ocaliva's net sales for the entire 2021 calendar year were $363.5 million, including net sales in the USA of $260.8 million, an increase of 16% from the previous year.
According to Dr Reddy's, the generic version of Ocaliva was introduced to the Indian market in May 2020.