Aurobindo Pharma has received tentative approval from the US FDA to manufacture and market duloxetine hydrochloride delayed-release capsules 20 mg, 30 mg and 60 mg. These capsules are the generic equivalent of Eli Lilly and Company Cymbalta delayed-release capsules and indicated for the treatment of major depressive disorder and falls under neurological therapeutic category. As per IMS report, the product has a market size of approximately US$ 2.9 billion for the twelve months ended June 2010.

The company filed ANDA with Paragraph IV certification with first to file status and is currently under litigation in the United States District court for the Southern District of Indiana, Indianapolis division with Eli Lilly and Company.

Aurobind now has a total of 128 ANDA approvals which includes 98 final approval and 30 tentative approvals from US FDA.