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Your search for “patent exclusivity” returned the following results.
…drugs have been approved, and what the relevant periods of orphan drug exclusivity apply to. We understand that the database will be revamped soon (perhaps later this year) to make…
…a case involving a district court interpreting the Hatch-Waxman 180-day exclusivity provisions that was vacated as moot on appeal continued to carry some weight. Inwood Laboratories, Inc. v. Young, 723…
…on the edge of his seat watining for other guidances identified in the “Generics” category of the Guidance Agenda, including “180 Day Exclusivity: Guidance for Industry;” “Three-Year Exclusivity Determinations for…
…designation, the process for requesting fast track designation, and the criteria for determining whether an application qualifies for the 5 additional years of QIDP market exclusivity Key Findings Since 2012,…
…Federal Food, Drug, and Cosmetic Act, which provides FDA the authority to grant exclusivity for drugs containing single enantiomers for another 5 years. Perhaps this incentive will be used more…
…forms of complex active ingredients or sites of action, are generally high-cost medicines that are not frequent targets of generic development regardless of patent or exclusivity status. These drugs are…
…2017, FDA proposes that 351(k) applications be categorized into two types as a result of the exclusivity provisions at PHS Act § 351(k)(7). Under PHS Act § 351(k)(7), a 351(k)…
…applicant’s 180-day exclusivity period. The bill, H.R. 573, is almost identical to the bill Rep. Emerson introduced during the 110th Congress – H.R. 806. The Senate version of that bill…
…in 2023. Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He…
…day before the pediatric exclusivity attaching to the ‘130 patent expired, which would have allowed approval of tentatively approved ANDAs on Monday, March 4,2013. FDA carefully evaluates assertions that the…
…postmarketing reporting requirements, labeling updates, patent listing, exclusivity eligibility, and drug-safety related requirements or procedures; indeed, PANDA holders have typically elected which regulatory scheme to follow. FDA therefore seeks industry…
…of each of the manufacturer’s drugs approved by the FDA in the previous three calendar years, and the name of each drug that lost patent exclusivity in the previous three…
…legislation requires CHHSA to select drugs based on priority and the need for competition, but often those high priority, expensive drugs are still subject to patents and exclusivity periods. As…
…the Act looks strikingly similar to the BLOCKING Act of 2019. His post describes how the Act would significantly alter the 180-day exclusivity provisions, the incentives for such exclusivity, as…
…a targeted area of interest for the government. Hatch-Waxman 180-Day Exclusivity Kurt R. Karst continues his coverage of the BLOCKING Act, legislation that could make 180-day exclusivity eligibility unpredictable for…