As per the post published on FDA law Blog by Mr. Kurst R Karst
USPTO has finalized the determination that U.S. Patent 5817338, which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a Patent term Extension (“PTE”) because the PRILOSEC OTC New Drug Application was not the first permitted commercial marketing or use of omeprazole, and because the PTE application was not timely submitted. (The PTE application was submitted on the 61st day after the date of NDA approval).
The details can be read here.
The decision can be read here.
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