Depomed Inc., a specialty pharmaceutical company, has reported that its lawsuits against two filers of Abbreviated New Drug Applications (ANDAs) for Gralise (gabapentin) have been dismissed.
Watson Laboratories has withdrawn its Gralise ANDA. Par Pharmaceutical has amended its Gralise ANDA and is no longer seeking approval of the ANDA prior to the expiration of Depomed's patents listed for Gralise in the FDA publication commonly known as the Orange Book.
As a result, the US District Court for the District of New Jersey has granted the parties' request for dismissal of Depomed's lawsuits against Watson and Par for infringement of Depomed's Gralise patents. As previously disclosed, in October 2012 Depomed's patent lawsuit against Impax was dismissed following Impax's withdrawal of its Gralise ANDA.
Depomed's patent litigation against the remaining three Gralise ANDA filers continues in the US District Court for the District of New Jersey.