Menu
Your search for “patent exclusivity” returned the following results.
…180-day exclusivity. Judge Lamberth’s order declares that the delisting of the ‘952 patent was unlawful, orders FDA to relist the patent in the Orange Book and restore Teva’s Paragraph IV…
…exclusivity and granted 3-year exclusivity, provided the statutory requirements are met. This means that order counts, and that to obtain NCE exclusivity for a FDC drug containing new and old…
…(NCE) exclusivity, 3-year new clinical trial exclusivity, and exclusivity for biological products. The Board will not review or make recommendations with respect to all exclusivity determinations in these areas, but…
…new clinical investigation exclusivity based on a small stack of Letter Decisions we obtained that were issued by the Exclusivity Board in the Center for Drug Evaluation and Research –…
…U.S. Patent No. 6,878,703 (“the ‘703 patent”) – is apparently the only remaining exclusivity-bearing patent, and, as a result of the patent being disclaimed, is listed in the Orange Book…
…trade name. The patent is apparently the first patent listed in the Orange Book for those brand-name drug products.) Because of the pre-MMA patent-by-patent approach to 180-day exclusivity, FDA’s interpretation…
…listed in the Orange Book for HECTOROL: U.S. Patent No. 5,602,116 (“the ‘116 patent”), a method-of-use patent, U.S. Patent No. 7,148,211 (“the ‘211 patent”), a formulation (drug product) patent, and…
…the ‘952 patent and restore the company’s paragraph IV patent certification, and declare that Teva is entitled to 180-day exclusivity. Teva also requests that the court enjoin FDA from granting…
…6,001,876 with respect to NDA 021446 and U.S. Patent No. 6,197,819 with respect to NDA 021723); cefdinir (OMNICEF) (U.S. Patent No. 4,559,334 with respect to NDA 050739 and U.S. Patent…
…FDC Act, under which exclusivity is patent-by-patent, thereby giving rise to the possibility of shared 180-day exclusivity. That is, where there are, for example, two Orange Book-listed patents for a…
…of KYTRIL. The application also contained a paragraph III certification (date of patent expiration) and a “section viii statement” to a method-of-use patent. Roche, the NDA holder/patent owner, did not…
…FDA explains that “[t]he first patents for Restasis were listed in the Orange Book in late 2008: U.S. Patent Nos. 4,839,342 (the ‘342 patent) and 5,474,979 (the ‘979 patent).” These…
…Teva’s exclusivity tied to the ‘068 patent. Mylan sued FDA, arguing both that (1) Teva’s exclusivity period tied to the ‘068 patent had expired; and (2) the ‘048 patent was…
…recently ruled 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…
…If a patent owner has not been involved in the regulatory process—directly or indirectly—then that patent owner has not lost any patent life. After all, it never invested the time…