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Your search for “patent exclusivity” returned the following results.
…of them: Orphan Drugs in the United States (Part one): Growth Trends in Rare Disease Treatments Orphan Drugs in the United States (Part two): Exclusivity, Pricing and Treated Populations Government…
…high-stakes regulatory submissions, Mike has litigated a number of significant Hatch-Waxman matters arising from the award or denial of 180-day exclusivity, 3-year and 5-year exclusivity, orphan drug exclusivity, 30-month stays,…
…of Columbia dealt a blow to K-V Pharmaceutical Company’s (“KV’s”) efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, by granting FDA’s…
…initiate a rulemaking proceeding nearly one year after FDA approved the drug (and granted Eisai five years of new chemical entity exclusivity, though the start of that exclusivity is being…
…New Chemical Entity (“NCE”) exclusivity and 7-year orphan drug exclusivity under NDA No. 022250 to improve walking in individuals with multiple sclerosis. Although AMPYRA is approved with a Risk Evaluation…
…that companies may consider that other incentives, such as provision of an additional period of “market exclusivity,” may be more effective at incentivizing drug development than the priority review vouchers….
…notwithstanding another company’s orphan drug exclusivity for the same drug for the same indication, and/or to obtain a separate period of orphan drug exclusivity – has historically been a bit…
…and (3) Exclusivity (presumably carefully worded to avoid another tussle over “market” versus “data” exclusivity – see our previous post here). Many of the questions are drafted to elicit an initial…
In a previous post, we reported on an assessment conducted by the Analysis Group, Inc. on the effects of authorized generics on paragraph IV patent certifications. There, the authors concluded…
…statute. Second, a “regulatory, scientific, and legal pathway” would be established for the approval of generic biologicals. The budget document assures that a period of exclusivity would be guaranteed for…
…how those determinations affect approval and exclusivity decisions. We won’t repeat all of that here, but note that for large molecules (i.e., macromolecules), structural “sameness” means that the second drug…
…manufacturer or wholesale distributor from engaging in price gouging in the sale of an “essential off-patent or generic drug.” An essential off-patent or generic drug, for purposes of the Bill,…
…and market exclusivity and cited articles (e.g., “Do Fixed Patent Terms Distort Innovation?: Evidence from Cancer Clinical Trials”) indicating a need for revised incentives. (As we previously reported, Professor Erika…
…(the same number as in FY 2006), with the following breakdown in agreement types: Thirty-three of the agreements were final settlements of patent litigation brought by a brand company against…
…Oct. 1, 2017) (see our blog post here) Prohibits price gouging in the sale of an “essential or off-patent generic drug” “Essential” off-patent generic drugs to be designated by Maryland…