Glenmark Generics has confirmed that it filed Abbreviated New Drug Applications (ANDAs) for Lacosamide tablets and oral solutions with the U.S. Food and Drug Administration (US FDA) with a paragraph IV certification for the Orange-book listed patent.
A statement from Glenmark said that its ANDA products are generic versions of Vipmat, which are used in the treatment of partial-onset seizures in adults with epilepsy.
Trouble in paradise
On Wednesday, the drug companies holding the patent, UCB Inc., UCS Pharma GmbH, Research Corporation Technologies, Inc. and Harris FRC Corporation filed a patent litigation challenging the same in the U.S. District Court for the District of Delaware, seeking to prevent Glenmark from commercializing its ANDA product prior to the expiration of U.S. patent.
Pharmaceutical companies list their patents in the Orange Book which is managed by the US FDA, and a generic pharma company is required by law to notify the patent owner about its plans to sell a product that infringes the patent.
The lawsuit was filed under the provisions of the Hatch-Waxman Act. If it is successful in its challenge of the patent, Glenmark will garner 180-day exclusivity for its products, it said in the statement.
According to IMS health data, for the twelve months ending March 31, 2013, Vipmat Tablets and solution had total US sales of about $353 million.
Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals, and is a generic and active pharmaceutical ingredient (API) player. It has a presence in North America, and is developing its presence in the EU. It sells its free dosage forms (FDF) products in the U.S. and EU and FDF oncology products in South America.
