Prilosec OTC loses patent extension
This article was originally published in The Tan Sheet
Executive Summary
The U.S. Patent and Trademark Office dismisses AstraZeneca's application to extend a key product patent for the OTC proton pump inhibitor it licenses to Procter & Gamble. The agency explains in a Dec. 16 letter that Prilosec OTC is ineligible for a patent term extension because it was not the first instance of commercial marketing for the underlying active ingredient and because its application was submitted in an untimely fashion. The Prilosec OTC patent expires Oct. 6, 2015, according to FDA's Orange Book of approved drug products. An AstraZeneca spokesman says the firm is "disappointed" in PTO's denial, but "we remain confident in our intellectual property." Attorney Kurt R. Karst of Hyman, Phelps & McNamara, writes in the FDA Law Blog Jan. 4 that AstraZeneca will likely contest PTO's decision in court. He adds in a Jan. 7 interview that the denial "could mean earlier generics" in the PPI market "but we don't know at this point." Private-label OTC PPIs emerged in 2008 after Prilosec OTC lost market exclusivity (1"The Tan Sheet" Aug. 11, 2008, p. 3)
You may also be interested in...
Despite Prilosec OTC Weakness, P&G Grows With Price Hikes, Cost Cuts
Procter & Gamble's Prilosec OTC business felt the heat of private-label competition during the firm's latest quarter, the first full period since the brand lost market exclusivity as an OTC proton pump inhibitor
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.