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Your search for “patent exclusivity” returned the following results.
…22-351, for which FDA granted 3-year exclusivity) and for the treatment of Familial Mediterranean Fever (“FMF”) (NDA No. 22-352, for which FDA granted 7-year orphan drug exclusivity). The drug products,…
…who may lose their exclusivity rights in the interim. (See prior posts here and here, and a challenge to FDA’s position on the start of the exclusivity clock here.) Other…
…No. 21-664 for a new once daily dosing regime of Bromfenac Ophthalmic Solution, 0.09%, marketed by ISTA as BROMDAY, and granted ISTA a period of three-year new clinical investigation exclusivity…
…sponsor received exclusivity under [FDC Act § 527], or pediatric drugs for which the sponsor received an additional 6 months of exclusivity under [FDC act § 505A].” Added to the…
…forfeit 180-day exclusivity eligibility under 21 U.S.C. § 355(j)(5)(D)(i)(IV).” With median ANDA approval times hovering around 33 months these days, forfeiture of 180-day exclusivity eligibility under the failure to obtain…
…in line with other legislation introduced by Sen. Sanders to create a prize-based system for new drugs, instead of one with patent and non-patent exclusivity incentives (see here and here). …
…with current Good Manufacturing Practice. According to Apotex, both ANDAs were ready for approval on September 27, 2012 when 180-day exclusivity expired. Apotex states in its filing that FDA (or,…
…working for Hoffmann-La Roche in Washington, D.C. in the late 1990s. George Johnston, Vice President and Chief Patent Counsel at Hoffmann-La Roche, introduced me to the Hatch-Waxman Amendments. The complexity…
…the drug until DEA completes the drug scheduling process. As we previously reported, the delay will potentially adversely affect Eisai’s five-year exclusivity period if FDA maintains that the clock began…
…trackers (Citizen Petition Tracker, Legislation Tracker, 180-Day Exclusivity Tracker, and REMS Tracker) are linked to as well. We’ll update the scorecards periodically and post separately on items that are particularly…
…issue of 3-year exclusivity eligibility and the effects on generics, that petition is more about the scope of 3-year exclusivity than ANDA labeling carve-outs. Thus, we would not include a…
…that FDA approved last year. FDA has taken the position that the exclusivity clock began to run upon the drug’s approval, although EISAI cannot market the drug until it is scheduled…
…pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining…
…awarded 180-day exclusivity. As FDA explains in the Sandoz approval letter, 180-day exclusivity for generic LOVENOX, which is governed by the pre-Medicare Modernization Act version of FDC Act § 505(j),…
…Tablets, 0.6 mg, to prevent gout, treat gout flares, and treat Familial Mediterranean Fever (“FMF”) and granted periods of 3-year new clinical investigation exclusivity (related to the gout approvals) and…