UCB has filed lawsuits against 15 different companies it claims have infringed the patent of its epilepsy drug Vimpat.
The Belgium-based biopharma company filed the suits in the US District Court for the district of Delaware in the US following the original submission of an Abbreviated New Drug Application (ANDA) by Aurobindo to market its own version of Vimpat (lacosamide) in the US.
UCB hit back against this with a lawsuit demanding that Aurobindo not be allowed to market generic Vimpat until March 2022, when it says the patent of the drug’s patent is due to expire.
Other companies have also submitted their own ANDAs, however, encouraged by the prospect of a 180-day exclusivity period for the first generic product to successfully challenge UCB’s Vimpat patent.
These other firms include major players in the generics market, such as Glenmark, Apotex, Mylan, Ranbaxy, Sandoz, Sun Pharma and Watson, who all want to market their own versions of the drug for use as an adjunctive therapy in the treatment for partial-onset seizures in adults with epilepsy.
Zydus, ScieGen, Hetero USA, Breckenridge, Amneal, Alembic and Accord make up the other companies facing a legal challenge from UCB.
Vimpat has been a strong growth driver for UCB since its approval in 2008, making $353m in the US for the 12 months ending March 31, 2013, according to IMS, and UCB will be keen to retain exclusivity.
Along with other recent launches like Cimzia (certolizumab pegol) for rheumatoid arthritis and Crohn’s disease and the Neupro (rotigotine) patch for Parkinson’s disease, Vimpat has helped UCB weather the loss of patent protection for previous lead drug Keppra (levetiracetam) and continue the company’s growth.
“During 2012, UCB reached the ‘crossover point’ where the net sales of our new core medicines Cimzia, Vimpat and Neupro [exceeded] those of Keppra, UCB’s leading medicine for many years,” noted UCB’s CEO Roch Doliveux in the company’s financial statement for 2012.