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Your search for “patent exclusivity” returned the following results.
…patent “delisting” issues. FDA’s September 26, 2007 letter establishing the docket states: There is one patent listed for Acarbose Tablets, U.S. Patent No. 4,904,769 (the ‘769 patent), which expires on…
…Book as a drug product (formulation), drug substance (active ingredient), and method-of-use patent. The ‘867 patent is listed in the Orange Book as a method-of-use patent with a “U-1472” patent…
…the REPRIEVE supplemental NDA met the requirements for 3-year exclusivity, FDA granted it. The exclusivity is coded in the Orange Book as “M-180,” which is defined in an addendum to…
…product contains any previously approved active moiety (i.e., it is not compsed of all NCEs), then FDA has historically denied NCE exclusivity and granted 3-year exclusivity, provided the statutory requirements…
…exclusivity. . . . [Second,] [b]ecause section 505A(o) does not address other forms of exclusivity—including exclusivity afforded by the Orphan Drug Act, 21 U.S.C. § 360cc(a)—the barrier to generic-drug approvals…
…180-day exclusivity. And because no notice of a “section viii” statement is provided to the NDA holder or patent owner, and there is no patent infringement lawsuit, nobody would be…
…to an earlier-filed patent, the (“child”) patent term lasts for 20 years from the earlier (“parent”) patent application date. In 1984 policymakers chose to permit restoration of child patents, because…
…IV certification from Cobrek regarding U.S. Patent No. 5,602,116 (“the ‘116 patent”), a method-of-use patent covering HECTOROL. The initial 30-month stay reportedly expired in early July 2010. FDA approved HECTOROL…
…applicable to process patents (as opposed to product and method of use patents), however, the legislation differentiated between certain types of process patents. As explained in the House Report: [A]…
…NHL patients. Fast-forward to December 7, 2015. Although Teva’s orphan drug exclusivity (as extended by pediatric exclusivity) for TREANDA for the treatment of CLL expired on September 20, 2015, orphan…
…of the scope of exclusivity should be applied to all types of exclusivity conferred by sections 505(c)(3)[(E)] and 505(j)[(5)(F)] of the act. Therefore, when exclusivity attaches to an active moiety…
…an end on May 31, 2016 when FDA finally issued a new Exclusivity Determination concluding that VASCEPA is eligible for (i.e., granted) 5-year NCE exclusivity. The 16-page Exclusivity Determination, announced…
…proposed to giveth New Chemical Entity (“NCE”) exclusivity to certain Fixed-Dose Combination Drugs (“FDCs”) and has with the other hand taketh away the possibility of NCE exclusivity for other FDCs. …
…pediatric patients (aged 3-16) with neurologic conditions associated with problem drooling (e.g., cerebral palsy). FDA awarded periods of 3-year new clinical investigation exclusivity and 7-year orphan drug exclusivity, but not…
…U.S. Patent No. 5,827,529 (“the ‘529 patent”), which expired on March 30, 2014 – thereby qualifying Watson as a first applicant eligible for a period of 180-day exclusivity. Post-2003 (MMA),…