Aurobindo gets tentative US FDA nod for Lacosamide tablets

Drug is used in treatment of partial-onset seizures in patients with epilepsy aged 17 years and older

Hyderabad-based Aurobindo Pharma Limited has received the tentative approval for Lacosamide tablets from the US Food and Drug Administration (US FDA). The drug, a generic equivalent of UCB Inc's Vimpat, is used in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.

While announcing this development, the company also disclosed on Thursday that this abbreviated new drug application (ANDA) contains a para 4 certification and is currently under litigation in the US District Court for the District of Delaware between UCB, Harris FRC Corporation versus Aurobindo Pharma and its US subsidiary.

If the company wins the litigation it would get an exclusive marketing window of 180 days to sell the drug in the US, giving it a higher premium during the period because of the limited competition. The market size of the drug was approximately $593 million for the 12-month period ending January 2015, it said.

Several other Indian and foreign companies, including Sun Pharma and Glenmark Generics, had also filed ANDAs for Lacosamide. UCB and its associates filed cases of alleged infringement of its patent over Vimpat against as many as 15 companies in 2013, according to the previous reports.

US generics company Mylan stated in the past that it was one of the first companies to have filed a substantially complete ANDA for the drug and expects to be eligible for the marketing exclusivity upon final FDA approval. Other companies have also made similar claims.