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Your search for “patent exclusivity” returned the following results.
…that contain a Paragraph IV certification, but become eligible for approval during the review period as a result of no blocking patents or exclusivities (including 180-day exclusivity) and no applicable…
…show the 12-year-to-7-year change. The 7-year period (or 7.5 years with pediatric exclusivity) would match the amount of exclusivity for a biological product granted under the Orphan Drug Act. In…
…do not lose patent or non-patent exclusivity on newly approved drugs because of drug scheduling delays. If enacted, the bill would presumably moot pending litigation Eisai initiated against FDA concerning…
…and any 180-day exclusivity available to Teva, the only obstacle for generic applicants to obtain full approval of their ANDAs is U.S. Patent #4,804,663 (“the ‘663 patent”). This patent expired…
…granted Akorn’s Motion to Amend its Answer to include a claim for a declaratory judgment of noninfringement of U.S. Patent No. 5,508,269 (“the ‘269 patent”). The ‘269 patent, which expires…
…of approval of Teva’s [ANDAs] for the drug at issue here, eptifibatide.” INTEGRILIN is covered by five Orange Book-listed patents. Two of the patents, to which one of Teva’s ANDAs…
…patents that have been cancelled or invalidated by PTAB, requiring FDA to remove from the Orange Book such patent information, other than patents subject to challenges that may result in…
…2030 are U.S. Patent No. 8,232,250 (“the ‘250 patent”) and U.S. Patent No. 8,399,413 (“the ‘413 patent”). Subsequently, information on U.S. Patent No. 8,969,302 (“the ‘302 patent”); U.S. Patent No….
…to a newly listed antibiotic drug patent. To date, few patents have been submitted to FDA for Orange Book listing. The first “old” antibiotic patents were listed on October 24,…
…Amgen sued Sandoz for refusing to participate in the exchange of patent information under the BPCIA. There, the Federal Circuit determined that the patent dance was voluntary (see our prior…
…on patent settlement agreements, but also touched on myriad other issues, including patent use codes, authorized generics, citizen petitions, and so-called “product hopping,” Commissioner Rosch commented that although he supports…
…the FTC’s 2010 Annual Report. Among other things, including allegedly false or unsupported claims concerning dietary supplements, the 96-page report highlights the Commission’s efforts to stop allegedly anticompetitive “pay-for-delay” patent…
…§ 156(a)(5)(A), which states that the term of a patent claiming a drug shall be extended from the original expiration date of the patent if, among other things, “the permission…
…bill was in the works prior to the enactment of FDASIA) – to add 6-months of marketing exclusivity to 5-year new chemical entity exclusivity, 3-year new clinical investigation exclusivity, “or”…
…listed in the Orange Book. Only one of the Potassium Chloride products is included on the current List of Off-Patent, Off-Exclusivity Drugs, FDA’s “hit list” for generic manufacturers, published in…