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sokol

Re: Doc328 post# 232138

Saturday, 01/25/2020 8:53:05 AM

Saturday, January 25, 2020 8:53:05 AM

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Yes, if a patent is listed in the Orange Book for a brand name drug, the FDA will not approve a generic version of that drug. The FDA acts in a minesterial capacity, and it does not determine the validity or enforceability of patents, it merely maintains the Orange Boook and list patents according to its procedural guidelines/applications, etc.
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