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Your search for “patent exclusivity” returned the following results.
…to us a new exclusivity term: “balance exclusivity.” Certainlty we’re all familiar with “umbrella exclusivity” in the 5-year New Chemical Entity exclusivity space. As we mentioned earlier this week, FDA…
…of marketing exclusivity? The BPCIA’s principal authors, in their December 21, 2010 letter, felt compelled to address FDA’s characterization of the 12-year exclusivity period as a period of “marketing exclusivity”…
…FDA may not condition the delisting of a patent on the existence of patent litigation and deprive an ANDA applicant eligible for 180-day exclusivity of such exclusivity does not apply…
…for 180-day exclusivity (U.S. Patent No. 5,912,013 (“the ‘013 Patent”)), and FDA’s interpretation that 180-day exclusivity terminates with the expiration of another patent on which Nostrum qualified for 180-day exclusivity…
…two recently issued patents – U.S. Patent Nos. 7,858,122 (“the ‘122 patent”) and 7,863,316 (“the ‘316 patent”) (both titled “Extended Release Formulation of Levetiracetam”) – are invalid. Par’s declaratory judgment…
…product from Abbott) applied for two PTEs based on these approvals – one for either U.S. Patent #5,376,634 (“the ‘634 patent”), #6,265,536 (“the ‘536 patent”), or #6,107,458 (“the ‘458 patent”)…
…180 day exclusivity, where the first applicant has not yet received final approval, a trigger of the first applicant’s 180 day exclusivity. This means the period of exclusivity would immediately…
…options are inadequate. In an October 1, 2015 Exclusivity Letter Decision, the CDER Exclusivity Board examines whether or not a period of 3-year exclusivity the Agency apparently granted after approving a…
…first applicant’s continuing eligibility for exclusivity. (Perhaps the most prominent examples of the occurrence of this scenario concerned Ranbaxy Laboratories. Ranbaxy, which was a first applicant eligible for 180-day exclusivity…
…patent”), and 6,294,197 (“the ‘197 patent”). Pediatric exclusivity for the ‘578 patent expired on September 21, 2012, and pediatric exclusiviy for the ‘990 and ‘197 patents expires on April 26,…
…505(b)(2) NDA for Lumryz, a sodium oxybate drug product referencing Jazz Pharmaceuticals’ Xyrem. Xyrem is listed in the Orange Book with multiple patents, including the aforementioned method-of-use patent, U.S. Patent…
…a “Patent Delist Request Flag” – U.S. Patent Nos. 6,248,735 and 6,316,443 (on April 18, 2008) – identifying that the NDA holder has withdrawn the patent and submitted a request…
…challenged Hi-Tech on one of those patents – U.S. Patent No. 4,797,413 (“the ‘413 patent”) – and Hi-Tech lost. The ‘413 patent expired on April 28, 2008, but was subject…
…ANDA to FDA containing a Paragraph IV certification to a particular patent. Pre-MMA 180-day exclusivity is triggered either by first commercial marketing (for all patents), or by a court decision…
…And this case is no exception. It is a story of exclusivity gained, exclusivity lost, exclusivity regained, exclusivity lost again, and regained yet again. As we recently discussed, FDC Act…