16 July 2013Americas

Glenmark confirms Vimpat challenge

Pharmaceutical company Glenmark Generics has confirmed that it has filed Abbreviated New Drug Applications (ANDAs) with the US Food and Drug Administration (FDA) to market generic versions of epilepsy drug Vimpat.

Glenmark seeks to make an oral solution and tablets of varying dosages with Vimpat’s active ingredient lacosamide.

UCB Inc holds approved new drug applications covering Vimpat for use as a tablet, and as oral and intravenous solutions. It lists the patent RE 38,551, which expires on March 17, 2022, in the Orange Book.

Several companies, including Sun Pharma, Ranbaxy and Mylan, filed ANDAs challenging the patent, and on July 10 UCB responded by launching a series of lawsuits to stop the generics from making their own versions of Vimpat.

Due to provisions of the Hatch-Waxman Act, if Glenmark is confirmed as the first to file its ANDA, and is successful in its challenge of UCB’s patent, it will receive 180 days of market exclusivity.

However, William Baton, partner at Saul Ewing LLP, said that in this case “more than one company could be a ‘first filer’,” meaning that more than one generic company may be granted exclusivity.

“If the generic companies submit their ANDAs on the same day, and they’re approved for filing by the FDA, multiple companies could be ‘first filers’,” he said.

Many generic companies consider their ANDA filing dates to be a “closely guarded secret,” he said: “They don’t always want the other generic companies – their competitors – to know they are a first filer.”

Though he noted that at least Mylan and Actavis/Watson have released statements confirming they believe they are a first filer.

Any generic defendant that prevails in its challenge and obtains FDA approval of its ANDA, even if it is not the first to file, may enter the market with its generic Vimpat after the first-to-file generic has had its 180 days of exclusivity, Baton said.

“They [generic companies] may believe pursuing this case is still a profitable venture, even if they’re not the first filer, if there is a good market for the drug,” he continued.

UCB’s tablets and solution had total US sales of approximately $353 million in the 12 months ending March 31, 2013, according to IMS Health data.

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