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HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.
Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.
The application contained a Paragraph IV certification, a legal assertion that the patents covering Dexilant are invalid, unenforceable or not infringed. Takeda filed suit against Impax in the U.S. District Court for the Northern District of California on Friday to prevent the launch, Impax said.
Dexilant delayed-release capsules had sales of $20 million in the 30-mg strength and $261 million in the 60-mg strength during the 12 months ended in January, according to Wolters Kluwer Health.
Upon FDA approval, Impax expects entitlement to 180 days of market exclusivity in which to compete directly with Takeda’s branded version of the drug. Patents covering Dexilant are scheduled to expire in 2020, 2026 and 2027, according to FDA records.