Intercept reaches agreement with Dr. Reddy’s on generic Ocaliva
Intercept Pharmaceuticals and its subsidiary Intercept Pharma Europe entered into a settlement agreement on Aug. 16, 2022 with Dr. Reddy’s resolving previously disclosed patent litigation.
[Read more: Dr. Reddy's intros OTC naproxen sodium tablets]
The case concerned the submission by Dr. Reddy’s of an Abbreviated New Drug Application seeking approval to market a generic version of Ocaliva (obeticholic acid) 5 mg and 10 mg tablets prior to expiration of the company’s U.S. Patent Nos. RE48,286; 9,238,673; 10,047,117; 10,052,337; 10,174,073; 10,751,349; and 10,758,549, according to an SEC filing.
Under the terms of the agreement, Intercept granted Dr. Reddy’s a nonexclusive, non-sublicensable, non-transferable, royalty-free license to commercialize its generic version of Ocaliva in the United States commencing on Oct. 26, 2035, or earlier under certain circumstances.
[Read more: Dr. Reddy's Aurigene Pharmaceuticals names CEO]
The parties will file the settlement agreement with the Federal Trade Commission and the Department of Justice pursuant to applicable law and will terminate their pending litigation pursuant to a consent judgment that is subject to court approval. Similar patent litigation previously disclosed by the company against five other ANDA filers seeking approval to market generic Ocaliva remains pending.