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Your search for “patent exclusivity” returned the following results.
…still embroiled in patent infringement litigation under the BPCIA’s so-called “patent dance” procedures (which our friends over at the Big Molecule Watch Blog have been closely following), so it’s not…
…nothing in proposed FDC Act § 505G affects any period of patent or non-patent exclusivity applicable to a brand-name listed drug. Reminder: Register now for the May 3, 2016 Virginia…
…an incentive different from the standard grants of patent and non-patent marketing exclusivities (S. 2055, the Medical Countermeasure Innovation Act of 2015). We promised we would address the second bill…
…and Patent Cheat Sheet to Maximize Global Biosimilars Market Share and Minimize Risk.” During the main conference, attendees will hear from experts on myriad topics, including the latest on FDA’s…
…for purposes of orphan designation. Hyperion’s persistence paid off. FDA approved RAVICITI on February 1, 2013 and granted a period of orphan drug exclusivity that expires on February 1, 2020….
…human tissue, gene, and cell products. Attendees will learn about the abbreviated pathway to market for biosimilar biological products and associated intellectual property issues, including exclusivity and biologics patent litigation….
…VII makes significant changes to the law to enhance FDA’s medical device inspection process. Title VIII is intended to improve generic drug access and creates a new 180-day exclusivity incentive…
…of New Chemical Entity exclusivity VASCEPA (icosapent ethyl) Capsules, 1 gram, (NDA 202057) (see our previous post here), that then led to yet another first, the dismissal of related ANDA…
…H.R. 2430 concerning Competitive Generic Therapies and a new 180-day exclusivity regime (see our previous post here). Several other amendments failed to garner the votes necessary for inclusion in the…
…of use seem like they are a direct response to the common practice of skinny-labeled generics. And questions about exclusivity when multiple applications for interchangeability are submitted and ready for…
…(pegfilgrastim). A common tactic in the small molecule world to introduce additional hurdles to generic approval in an effort to extend market exclusivity, it isn’t typical to see this type…
…of exclusivity on the reference product have expired – FDA rejects this alternative because it is contrary to the goal of Congress to ensure consumers benefit from lower-priced versions of…
…rare as revocation of orphan drug exclusivity, which has happened only once – see our previous post here). Until recently, we were aware of only three orphan drug designation revocations…