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www.fdanews.com/articles/100965-barr-sued-over-ritalin-la-patent-challenge

Barr Sued Over Ritalin LA Patent Challenge

November 12, 2007

Celgene and Novartis filed suit after receiving notice that Barr Laboratories submitted an abbreviated new drug application (ANDA) with Paragraph IV certifications for generic Ritalin LA.

Barr seeks to market generic Ritalin LA (methylphenidate HCl) extended-release capsules, 10, 20, 30 and 40 mg. The drug is indicated for treating attention-deficit/hyperactivity disorder and had U.S. sales of approximately $109 million during the 12-month period that ended in August, Barr said.

The company’s ANDA contained Paragraph IV certifications for two of Celgene’s patents, which are listed in the Orange Book as expiring in 2015. The patents cover certain extended-release dosage forms of methylphenidate.

Celgene and Novartis filed their complaint in the U.S. District Court of New Jersey alleging that Barr is willfully and deliberately infringing on the patents. They are asking the court to order that Barr’s product may not be approved until after the patents expire.