Mylan Inc., a global pharmaceutical company committed to setting new standards in health care, confirmed that the company has been sued by UCB, Inc., UCB Pharma GMBH, Research Corporation Technologies, Inc. and Harris FRC Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Lacosamide tablets, 50 mg, 100 mg, 150 mg and 200 mg. This product is the generic version of Vimpat, which is approved as an adjunctive therapy to treat partial-onset seizures of people diagnosed with epilepsy aged 17 years and older.
Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon final FDA approval. The plaintiffs have filed a lawsuit against Mylan and several other ANDA filers in the United States District Court for the District of Delaware.
For the 12 months ending March 31, 2013, Vimpat had US sales of approximately $338 million, according to IMS Health.
Currently, Mylan has 173 ANDAs pending FDA approval representing $82.9 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $22.6 billion in annual brand sales, for the 12 months ending December 31, 2012, according to IMS Health.