Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Barr Pharmaceuticals has confirmed that its subsidiary, Barr Laboratories has initiated a challenge of the patents listed by Cephalon, in connection with its Fentora tablets equivalent to fentanyl base 100mcg, 400mcg, 600mcg and 800mcg.
Subscribe to our email newsletter
Barr has filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic Fentora product with the FDA in February 2008. Following receipt of the notice from the FDA that Barr’s ANDA had been accepted for filing, Barr notified the new drug application and patent holder.
On July 22, 2008, Cephalon and Cima Labs filed suit in the US District Court of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.