A federal court in Delaware finds five patents on Zegerid prescription proton pump inhibitor invalid due to obviousness, likely also removing a hurdle for private label versions of Zegerid OTC (omeprazole/sodium bicarbonate), just launched by Merck/Schering-Plough. Par Pharmaceuticals filed the patent challenge after submitting abbreviated new drug applications to FDA in 2007 for generic Zegerid, the drug's originator Santarus said April 14. According to FDA's Orange Book, Merck has no period of market exclusivity for Zegerid OTC, approved for sale in December 2009 (1"The Tan Sheet" Dec. 7, 2009). A spokesman for Perrigo, which would likely be among the first to pursue a Zegerid OTC generic, said once patents are overcome, ANDA approval will take approximately two years
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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.’
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
