Perrigo files an abbreviated new drug application for a generic equivalent of the heart burn reliever Zegerid OTC, drawing a patent infringement suit from Schering-Plough HealthCare Products filed Sept. 20 in the U.S. District Court of New Jersey. Perrigo notes a federal court in Delaware ruled earlier this year in a similar suit that the same patents were invalid due to obviousness (1"The Tan Sheet" April 19, 2010). An appeal is pending in the Delaware case, which is related to Zegerid prescription products. Perrigo said in a Sept. 24 release that it notified Schering-Plough prior to filing the ANDA for the omeprazole 20 mg /sodium bicarbonate 1,100 mg drug. The private labeler cites data from Chicago-based IRI Symphony that places sales of Zegerid OTC at about $60 million annualized in the most recent month
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.
