Intercept Pharmaceuticals Settles Patent Litigation with Dr. Reddy's Laboratories

Strategic Insights -

Intercept Pharmaceuticals, Inc. and its subsidiary Intercept Pharma Europe Limited have entered into a settlement agreement with Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. resolving patent litigation concerning the submission of an Abbreviated New Drug Application (ANDA) for a generic version of Ocaliva(r) (obeticholic acid) 5 mg and 10 mg tablets. The agreement grants Dr. Reddy's a non-exclusive, non-sublicensable, non-transferable, royalty-free license to commercialize its generic version of Ocaliva in the United States, commencing on October 26, 2035, or earlier under certain circumstances.

Key Takeaways:

  • Intercept Pharmaceuticals, Inc. and its subsidiary Intercept Pharma Europe Limited entered into a settlement agreement with Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. on August 16, 2022.
  • The settlement resolves patent litigation concerning the submission of an ANDA for a generic version of Ocaliva(r) (obeticholic acid) 5 mg and 10 mg tablets.
  • The agreement grants Dr. Reddy's a non-exclusive, non-sublicensable, non-transferable, royalty-free license to commercialize its generic version of Ocaliva in the United States.
  • The license commences on October 26, 2035, or earlier under certain circumstances.
  • Similar patent litigation previously disclosed by the Company against five other ANDA filers seeking approval to market generic Ocaliva remains pending.
  • The settlement agreement will be filed with the Federal Trade Commission and the Department of Justice pursuant to applicable law.

Statistics:

  • The settlement agreement was reached on August 16, 2022.
  • The license granted to Dr. Reddy's will commence 13 years after the filing of the ANDA by Dr. Reddy's.
  • The patent litigation against five other ANDA filers seeking approval to market generic Ocaliva remains pending.

Sources:

  • UNITED STATES SECURITIES AND EXCHANGE COMMISSION, Form 8-K (Current Report), August 16, 2022.