Intercept Settles Ocaliva Litigation With Reddy's Lab

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  • Intercept Pharmaceuticals Inc ICPT and its subsidiary Intercept Pharma Europe Limited settled patent litigation with Dr. Reddy’s Laboratories Ltd RDY.
  • The litigation concerns 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 before the expiration of the Company’s U.S. patents.
  • Related: Intercept Shares Jump After Reissuing Annual Guidance.
  • Under the terms of the agreement, Intercept granted Dr. Reddy’s a non-exclusive, non-sublicensable, non-transferable, royalty-free license to commercialize its generic version of Ocaliva in the U.S. commencing on October 26, 2035, or earlier under certain circumstances. 
  • Similar patent litigation previously disclosed by Intercept against five other generic filers seeking approval to market generic Ocaliva remains pending.
  • Price Action: ICPT shares traded 0.94% lower at $17.90 on the last check Wednesday.
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