Trade Resources Company News Depomed's Lawsuits Against Watson Laboratories and Par Pharmaceutical in Relation to ANDAs

Depomed's Lawsuits Against Watson Laboratories and Par Pharmaceutical in Relation to ANDAs

Depomed's lawsuits against Watson Laboratories and Par Pharmaceutical in relation to Abbreviated New Drug Applications (ANDAs) for Gralise (gabapentin) have been dismissed.

The company said that both the companies no longer sought approval of their drugs before the expiration of Depomed's patents.

Depomed said Watson Watson Laboratories withdrew its application with US Food and Drug Administration for generic Gralise which is a once-daily tablet to control pain after shingles.

Par Pharmaceutical on the other hand 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.

The US District Court for the District of New Jersey has granted request to the dismissal of Depomed's lawsuits against Watson and Par for infringement of Depomed's Gralise patents.

In October 2012, Depomed's patent lawsuit against Impax was also dismissed, in view of Impax's Gralise ANDA withdrawal.

Depomed at present has three pending Gralise ANDA patent litigation suits in the US District Court for the District of New Jersey, against companies who had filed for approval of their Gralise generics.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/depomeds-lawsuits-against-watson-laboratories-and-par-pharmaceutical-dismissed-281212
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Depomed's Lawsuits Against Watson Laboratories and Par Pharmaceutical Dismissed