TWi settles with Takeda over Dexilant generic

Tawiwan-based generics firm TWi Pharmaceuticals (4180: Taiwan) has entered into a settlement agreement with Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) to settle and dismiss all outstanding patent litigation related to TWi's generic dexlansoprazole delayed-release capsules for oral administration in 30mg and 60mg dosage strengths.

An Abbreviated New Drug Application for TWi’s generic product is currently under review at the US Food and Drug Administration. If approved, TWi’s product would be a generic version of Takeda's Dexilant, which is indicated for 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.

The Settlement Agreement allows TWi to launch its generic Dexilant 180 days after the first applicant to file its ANDA 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.