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Several generic companies have come up short in their attempt to get into the Oxycontin and Risperdal market due to two court rulings announced Oct. 16.
The Canadian government has amended its Food and Drug Regulations to extend the period of guaranteed market exclusivity for new drugs from five to at least eight years, with an additional six-month extension for drugs that have undergone clinical trials on pediatric populations.
Warner Chilcott is forbidden to enter reverse payment agreements — where brand companies pay generic competitors to delay launching their version of a drug — with generic pharmaceutical companies, under a legal settlement the drugmaker has reached with the FTC.
The European Patent Office (EPO) issued an opinion upholding Pfizer’s Lipitor patent, siding with the company in a patent infringement case filed by generic drugmaker Ranbaxy.
A U.S. appeals court has denied Ranbaxy’s petition to rehear its August decision in a patent case involving atorvastatin, the active ingredient in Lipitor, according to Pfizer.
Dr. Reddy’s Laboratories will begin distributing an authorized generic version of GlaxoSmithKline’s (GSK) migraine drug Imitrex in
late 2008, under terms of a patent settlement.
Shire Pharmaceuticals announced Andrx has filed an application to market a generic version of Shire’s attention-deficit/hyperactivity disorder (ADHD) drug Adderall XR.