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news.Caraco Pharmaceutical Laboratories has confirmed a US Federal Court of Appeals ruling that Caraco does not infringe the Ortho-McNeil Pharmaceutical patent on Ultracet.
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Caraco’s Tramadol with acetaminophen is the generic equivalent of Ortho McNeil’s analgesic, Ultracet. The company commenced shipment of Tramadol with acetaminophen following the FDA’s approval to manufacture market and distribute the generic product.
In September 2004, Ortho-McNeil filed a complaint in a United States District Court alleging that Caraco’s filing of an abbreviated new drug application seeking approval to market its generic version of Ultracet infringed Ortho-McNeil’s patent, which expires on September 6, 2011.
In October 2005, arguments were heard in a United States District Court on the Caraco’s motion for summary judgment on the issue of non-infringement. The motion for summary judgment was granted in Caraco’s favor.
“We were confident of our position and are gratified that the Federal US Court of Appeals supported the ruling of the Eastern District Court of Michigan that we do not infringe,” commented Daniel Movens, CEO.