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Your search for “patent exclusivity” returned the following results.
…FAMVIR is listed in the Orange Book with five patents, including U.S. Patent No. 5,246,937 (“the ‘937 patent”). The ‘937 patent expired on September 21, 2010, but is subject to…
…patent listing regulations at 21 C.F.R. § 314.53 to require patent submission and Orange Book listing if such patents claim an integral part of an approved drug product rather than…
…sponsor or holder had with the United States Patent and Trademark Office; and (ii) (I) submit to the United States Patent and Trademark Office any information material to patentability with…
…also help clarify whether a listed patent will trigger a 30-month patent litigation stay, otherwise delay approval of a pending application, or require a carve-out. Previously, patent submission date information…
…Paragraph IV certification to a patent the NDA holder submitted for a converted OTC product can ground 180-day exclusivity. After all, such exclusivity attaches to every first-filed ANDA that “contains…
…here) – topic of 5-year New Chemical Entity (“NCE”) exclusivity. The question is: can 5-year NCE exclusivity be cut short, such that FDA can approve an ANDA or a 505(b)(2)…
…patent – U.S. Patent No. 4,703,063 (“the ‘063 patent”). The ‘063 patent expired on October 27, 2009, but is subject to a period of pediatric exclusivity scheduled to expire on…
…to the owners of certain patents listed in the Orange Book for OxyContin. Purdue and certain patent owners subsequently filed complaints in two district courts alleging patent infringement, and triggering…
…approved application under [FDC Act § 505(b)] for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement…
…of transitional products, FDA, with very little preamble, states that “any unexpired period of exclusivity” for a transitional product, “e.g., 5-year exclusivity, 3-year exclusivity, or pediatric exclusivity … would cease…
…exclusivity relates to the scope of new clinical investigations conducted by the NDA sponsor and approved in an sNDA, but that “AstraZeneca reads the statute to provide for exclusivity for…
…drug to fall within the latter’s zone of exclusivity? This case concerns the FDA’s test for making that determination. According to Otsuka, 3-year exclusivity “broadly covers any two drugs that…
By Kurt R. Karst – Disputes involving non-patent marketing exclusivity available to 505(b)(1) and 505(b)(2) NDA applicants – either 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity,…
…its patent challenge, and the related lack of incentive that subsequent generic challengers have to continue the patent fight when the first filer has settled and “parked” its exclusivity. Indeed,…
…trigger its pre-Medicare Modernization Act (“MMA”) 180-day exclusivity? Will the exclusivity remain “parked”? Or will the company be stripped of its exclusivity or otherwise work out a deal to relinquish…