Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg. Aurobindo was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, therefore, Aurobindo is eligible for 180 days of generic drug shared exclusivity. The launch of this product will be based on the outcome of the litigation in the United States Court with UCB.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB, Inc. Lacosamide Tablets is indicated for adjunctive therapy in the treatment of partial-onset seizures. The approved product has an estimated market size of $ 782 million for the twelve months ending February 2016 according to IMS.
This is the 73rd ANDA (including 15 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 257 ANDA approvals (221 Final approvals including 11 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.
