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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The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
