Handa Pharmaceuticals, LLC a specialty pharmaceutical company based in Fremont, California, confirmed that its Abbreviated New Drug Application (ANDA) for Dexlansoprazole Delayed Release capsules, 60 mg, a generic version of Takeda's Dexilant, has been accepted for review by the US Food and Drug Administration (FDA).

Based upon available information, Handa believes that it is the first applicant to file an ANDA for Dexilant containing a paragraph IV certification, under the provisions of the Hatch-Waxman Act. Should its ANDA for Dexlansoprazole Delayed Release capsules, 60 mg, be approved by the FDA, Handa believes that the product may be entitled to 180 days of generic market exclusivity.

According to IMS Health, annual sales of Dexilant delayed release capsules, 60 mg, in the US were about $300 million for the twelve months ended December 31, 2010.

Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Its executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate.

In December 2010, Handa announced that the US Food and Drug Administration (FDA) had granted tentative approval of the company's ANDA for Quetiapine Fumarate extended-release tablets, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg, a generic version of AstraZeneca's Seroquel.