An abbreviated new drug application (ANDA) for TWi’s generic product as delayed release capsules for oral administration in dosages of 30 mg and 60 mg is currently under review at the US Food and Drug Administration (FDA). If approved, TWi’s product would be a generic version of Takeda’s Dexilant.

The deal allows TWi to launch its generic dexlansoprazole 180 days after the first applicant to file its ANDA launches its generic dexlansoprazole, or on an earlier date under certain circumstances. Takeda and TWi have also entered into a license and supply agreement, allowing TWi to sell Dexilant in both dosage strengths as the authorized generic drug.

Ms Tina Guilder, President & CEO of TWi said that resolving the patent litigation with Takeda allows TWi to bring generic dexlansoprazole to the US market ‘many years prior to the last patent expiration date of Takeda’s patent(s)’, ‘furthering TWi’s goal of bringing affordable health care to patients’.

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. Dexilant had total US sales of approximately US$1 billion in 2014, according to IMS health data.

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