RDY - Intercept Dr. Reddy's settle patent dispute over Oclaiva generics

U.S. biotech Intercept Pharmaceuticals ( NASDAQ: ICPT ) and India-based Dr. Reddy's Laboratories ( RDY ) have reached an agreement to settle a lawsuit over Dr. Reddy's plans to market a generic version of Intercept's ( ICPT ) liver disease therapy Ocaliva.

The farnesoid X receptor agonist, also known as obeticholic acid (OCA), is indicated in the U.S., U.K., Europe, and several other countries as a treatment for primary biliary cholangitis in combination with ursodeoxycholic acid.

Filing an Abbreviated New Drug Application ("ANDA") to the FDA, Dr. Reddy's ( RDY ) had planned to introduce 5 mg and 10 mg tablets of generic OCA before the expiry of Intercept's ( ICPT ) patents.

Per the terms of the agreement, the Indian drugmaker will gain a non-exclusive, non-sublicensable, non-transferable, royalty-free license to market generic OCA in the U.S. from Oct. 2035 or earlier subject to certain conditions, Intercept ( ICPT ) said.

However, ICPT's legal disputes with several other drugmakers over OCA generics remain. The settlement with RDY is subject to court approval.

In July, Intercept ( ICPT ) announced plans to resubmit a new drug application for Ocaliva in nonalcoholic steatohepatitis, a liver disease with no currently approved medications.

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