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Your search for “patent exclusivity” returned the following results.
…of pediatric exclusivity that expires on April 21, 2019. The ‘148 patent is a reissue of the ‘300 patent, and the ‘096 patent is a reissue of the ‘819 patent. …
…applicant’s interpretation of the scope of a patent that it does not own (and, in particular, for a method-of-use patent that is identified in the Orange Book with a patent…
…our purposes here, it is important to note that the pre-MMA patent-by-patent approach to 180-day exclusivity means that a new Orange Book patent listing can significantly complicate and alter the…
…Patent and Trademark Office reissued the invalidated ‘068 patent as the ‘048 patent. The ‘048 patent was promptly listed in the Orange Book and several companies, including Teva and Mylan,…
…2020, the day after pediatric exclusivity applicable to U.S. Patent No. 6,716,830 (“the ‘830 patent”) expires. (The ‘830 patent is listed in the Orange Book with pediatric exclusivity expiring on…
…and issued an Order and Injunction requiring Novo Nordisk, Inc. (“Novo”) to change an Orange Book-listed patent use code for a patent (U.S. Patent No. 6,677,358 (“the ’358 patent”)) on…
…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., five-year, three-year, and orphan drug exclusivity) an application…
…(expiring on August 13, 2026); (2) U.S. Patent No. 8,227,484 (“the ‘484 patent”) (expiring on July 17, 2023); and (3) U.S. Patent No. RE 38,115 (“the ‘115 patent”) (expiring on…
…not expressly describe the scope of exclusivity for 3-year exclusivity, providing FDA discretion to make exclusivity determinations in a manner consistent with the statutory language and intent of Congress. In…
…180-day exclusivity. As Akorn noted in its comments, this means: the ‘979 patent was not an exclusivity-bearing patent; 180-day exclusivity for Cyclosporine Ophthalmic Emulsion, 0.05%, has not been forfeited under…
…FDA ultimately determined that 5-year new chemical entity exclusivity, instead of 3-year exclusivity, should be granted to each hyaluronidase applicant, the Agency did not address the scope of 3-year exclusivity…
…with the conclusion that drug patent settlement agreements are presumptively anticompetitive and unlawful. PUBPAT takes issue with the Patent and Trademark Office: People unfamiliar with the patent system, including specifically…
…references or otherwise relies upon the dormant therapy. (D) INTERIM PATENT EXTENSIONS.—Notwithstanding any provision of title 35, United States Code, with respect to any patent listed (or patent issuing on…
…identify 10 types of non-patent marketing exclusivities (or non-patent exclusivity extensions) recognized by the FDC Act? A: (1) 5-year New Chemical Entity Exclusivity; (2) 3-year new clinical investigation exclusivity for an…
…was an October 1, 2015 Exclusivity Letter Decision from the CDER Exclusivity Board examining whether or not a period of 3-year exclusivity the Agency granted after approving a Supplemental NDA…