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Your search for “patent exclusivity” returned the following results.
…patent evergreening, and product-hopping as major issues used to inappropriately impede competition: Patent thickets, or “continuation” patent applications, allow filers to obtain follow-on patents resulting in multiple patents on different…
…patent infringement litigation on U.S. Patent No. 6,503,894 in exchange for a profit-sharing arrangement and provided the generic competitors would not launch their generic versions of ANDROGEL until 2015. The…
…and Outcomes in Generic Drug Patent Litigation: An Empirical Investigation FTC Working Paper: Estimating the Effect of Entry on Generic Drug Prices Using Hatch-Waxman Exclusivity PricewaterhouseCoopers 2013 Patent Litigation Study…
…Otsuka ultimately contended that as a result of this period of exclusivity, the company is entitled to a 7-year period of total market exclusivity such that FDA is precluded from…
…UCB, Inc. (“UCB”) concerning 5-year NCE exclusivity for VIMPAT (lacosamide), and another petition (Docket No. FDA-2013-P-1376) from Covis Pharma S.à.r.l. (“Covis”) concerning 3-year new clinical investigation exclusivity for LANOXIN (digoxin)…
…one of the six 180-day exclusivity forfeiture provisions added to the FDC Act by the 2003 Medicare Modernization Act, 180-day exclusivity eligibility is forfeited if: The first applicant fails to…
…the [‘XXX] patents. As a first applicant, therefore, [Generic Applicant] may be eligible for 180 days of generic drug exclusivity for [Drug]. This exclusivity, which is provided for under section 505(j)(5)(B)(iv)…
…5 years of exclusivity that is added on to existing 3-year new clinical investigation exclusivity and/or 5-year NCE exclusivity. Thus, the enactment of H.R. 2985 would presumably mean that a…
…include the first Paragraph IV certification to an Orange Book-listed patent covering the Reference Listed Drug (“RLD”). (Perhaps in the context of a later-listed patent, or where all ANDA sponsors…
…a patent use code qualifies as “patent information” submitted under FDC Act §§ 505(b) and (c) and may be the subject of a counterclaim to correct or delete patent information. …
…occur under current law (i.e., while the first applicant is eligible for 180-day exclusivity prior to commercial marketing in addition to the 180-day period itself). 180-day patent challenge exclusivity is…
… MONISTAT 1 Combination Pack is listed in the Orange Book with two patents – U.S. Patent Nos. 5,514,698 (“the ‘698 patent) and 6,153,635 (“the ‘635 patent“). Both patents are…
…and the PHS Act, including 5-year New Chemical Entity exclusivity, 3-year New Clinical Investigation exclusivity, 7-year Orphan Drug exclusivity, and 12-year Reference Product exclusivity for biological products. In addition, patents…
…patent listing? Q17: Can you identify 10 types of non-patent marketing exclusivities (or non-patent exclusivity extensions) recognized by the FDC Act? Q18: How long did it take after the December…
…‘652 patent”), which is listed in the Orange Book for the contraceptive drug YASMIN (drospirenone 3 mg/ethinyl estradiol 0.03 mg) Tablets (NDA No. 021098) as a method-of-use patent. Based on…