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Your search for “patent exclusivity” returned the following results.
…and 7,410,957 (“the ‘957 patent”). Both the ‘634 and ‘957 patents are listed in the Orange Book as method-of-use patents and expire on May 6, 2023. The ‘634 patent, which…
…“marketing exclusivity” or “data exclusivity” (see our previous post here). Then there was President Obama’s Fiscal Year 2012 Budget, which proposed slashing the BPCIA’s 12-year exclusivity period, such that “innovator…
…approved at that time is entitled to 3-year exclusivity. AstraZeneca also argued that independent of the pediatric sNDAs FDA approved, Table 2 deserves exclusivity on its own merit because it…
…award a period of NCE exclusivity. Similar requests for NCE exclusivity recognition were made in petitions submitted to FDA earlier this year concerning STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)…
…exclusivity provisions allows for an award of NCE exclusivity for a newly approved FDC drug product containing an NCE and a previously approved drug. As we previously reported, Judge Contreras…
…the availability of 5-year New Chemical Entity (“NCE”) exclusivity for Ferring’s colonoscopy preparation, PREPOPIK (sodium picosulfate, magnesium oxide, and citric acid) for Oral Solution (NDA 202535; approved on July 16,…
…and 80 mg, a generic version of SmithKline’s COREG CR Extended-Release Capsules (NDA 022012). The Orange Book Cumulative Supplement showed the addition of periods of “PC” exclusivity (i.e., 180-day patent…
…for 180-day exclusivity triggers that exclusivity. Back in 2012, FDA applied the Agency’s pre-MMA interpretation of the statute with respect to Teva’s claim to 180-day exclusivity for a generic version…
…incentives that merely stack exclusivity periods upon one another, such as 6-month pediatric exclusivity (FDC Act § 505A) or 5-year Generating Antibiotic Incentives Now Act exclusivity (FDC Act § 505E) or…
…response after soliciting public comment on whether Teva forfeited 180-day exclusivity eligibility because the only exclusivity-qualifying patent – U.S. Patent No. 5,608,075 (“the ‘075 patent”), which was previously identified in…
…expired.” FDA issued its response after soliciting public comment on whether Teva forfeited 180-day exclusivity eligibility because the only exclusivity-qualifying patent – U.S. Patent No. 5,608,075 – “expired” last year…
…with respect to the applicability of pediatric exclusivity. Specifically, for post-September 2007 written requests, pediatric exclusivity will not apply to a particular period of patent or non-patent exclusivity if FDA…
…and safety” of their products to receive an additional 12 years of exclusivity. Under the Administration proposal, beginning in 2012, innovator brand biologic manufacturers would have 7 years of exclusivity…
…Orange Book for Warner Chilcott Pharmaceuticals, Inc.’s (“Warner Chilcott’s”) ASACOL – U.S. Patent Nos. 5,541,170 (“the ‘170 patent”) and 5,541,171 (“the ‘171 patent”), both of which expire on July 30,…
…biosimilar product, or to add into labeling an indication previously omitted because of unexpired patent or non-patent exclusivity (e.g., orphan drug exclusivity) protections on the reference product. Why not argue…