TWi Pharmaceuticals, Inc. ("TWi") today announced that it has entered into a Settlement Agreement with Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals America, Inc. (individually and collectively, "Takeda") to settle and dismiss all outstanding patent litigation related to TWi's generic dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths. An Abbreviated New Drug Application for TWi's generic product is currently under review at the U.S. Food and Drug Administration. If approved, TWi's product would be a generic version of Takeda's Dexilant®.
The Settlement Agreement allows TWi to launch its generic Dexilant® one-hundred eighty (180) days after the first applicant to file its ANDA (commonly known as "first-to-file" or "FTF") launches its generic Dexilant® product, or on an earlier date under certain circumstances. As part of the settlement, the parties also entered into a License and Supply Agreement allowing TWi and its affiliates to sell Dexilant® in both dosage strengths as the Authorized Generic.
"We are pleased to resolve the patent litigation with Takeda related to our pending ANDA for dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths. This settlement allows TWi to bring a generic Dexilant® to the U.S. market many years prior to the last patent expiration date of Takeda's patent(s) while eliminating the uncertainties and inherent risk of patent litigation and avoiding the substantial cost of continued litigation. Furthermore, the license and supply of the Authorized Generic from Takeda allows TWi to be the supplier of both strengths of a generic Dexilant® in the U.S. market for a period of time, which provides significant sales and marketing advantage as well as furthering TWi's goal bringing affordable healthcare to patients," said Tina Guilder, President & CEO of TWi.
The agreements are subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
Dexilant® is indicated for healing of all grades of erosive esophagitis, maintaining healing of erosive esophagitis and relief of heartburn, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease. For the 12 months ended December 31, 2014, the product had total U.S. sales of approximately $1.0 Billion, according to IMS health data.
Dexilant® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc.
TWi Pharmaceuticals, Inc.