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Your search for “patent exclusivity” returned the following results.
…No. 6,878,703 (“the ‘703 patent”) – see our previous post here – never materialized. Instead, an issue concerning pediatric exclusivity applicable to U.S. Patent No. 5,616,599 (“the ‘599 patent”) listed…
…Inc.’s (“Pfizer’s”) VIAGRA (sildenafil citrate) Tablets would infringe Orange Book-listed U.S. Patent No. 6,469,012 (“the ‘012” patent), which expires on October 22, 2019, and that the ‘012 patent is valid…
…the omission of certain patent-protected information) with regard to U.S . Patent Nos. 5,965,584 (“the ‘584 patent”) and/or 6,329,404 (“the ‘404 patent”), but does not also include a Paragraph IV…
…“relied upon,” the statutory provision is clear as to how 3-year exclusivity operates, and that it can be separated into two components: “entitlement to exclusivity and scope of that exclusivity.” …
…not consider the eligibility of Cuvposa for six-month pediatric exclusivity. Accordingly, this exclusivity period should now be recognized and attached to the remaining Cuvposa orphan drug exclusivity and patent periods….
…following question: “If my study qualifies for pediatric exclusivity, to what will the period of pediatric exclusivity attach?” FDA’s response (in relevant part): Pediatric exclusivity will attach to exclusivity and…
…of 180-day exclusivity when a company submits an ANDA containing both a Paragraph IV Certification to one patent and a Paragraph III Certification to another Orange Book-listed patent that does…
…is one patent listed in the Orange Book for PRECOSE (NDA #20-482), U.S. Patent No. 4,904,769 (“the ‘769 patent”), which expires on September 6, 2009. At least one generic applicant…
…Exclusivity Evaluation, and a 6-page Memorandum penned by the CDER Exclusivity Board – all from from January 2015 – FDA lays out the Agency’s rational for granting 3-year exclusivity for…
…NCE exclusivity and granted 3-year exclusivity, provided the statutory requirements were met. Up until October 2014, this meant that order counted, and that to obtain NCE exclusivity for a FDC…
…is now available. This decision, which finds that “the plain language of the exclusivity provisions of the Orphan Drug Act requires the FDA to recognize exclusivity for any drug that…
…FDA in a Written Request for which pediatric information would be beneficial. Pediatric exclusivity extends all other types of Orange Book-listed patent and non-patent marketing exclusivity (e.g., 5-year, 3-year, and…
…Act to add 6 months of marketing exclusivity to 5-year NCE exclusivity, 3-year new clinical investigation exclusivity, or 7-year orphan drug exclusivity for a drug product approved under an NDA…
…products identified by FDA in a Written Request (“WR”) for which pediatric information would be beneficial. Pediatric exclusivity extends all other types of Orange Book-listed patent and non-patent marketing exclusivity…
…to U.S. Patent No. 6,294,197 (“the ‘197 patent”), the pediatric exclusivity for which expires on December 18, 2017. Ranbaxy’s ANDA also contained a Paragraph III certification to now-expired U.S. Patent…