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Your search for “patent exclusivity” returned the following results.
…as well as another period of 3-year exclusivity and two patents scheduled to expire on June 29, 2023. The VYVANSE labeling states that the drug product is a therapeutically inactive…
…once the initial period of orphan drug exclusivity expires, and then later for the pediatric population indication once that second period of orphan drug exclusivity expires. But not all cases…
…argument regarding self-evergreening, or serial exclusivity, where either the same manufacturer or several manufacturers obtain multiple periods of sequential exclusivity for the same drug to treat the same disease. In…
…in the draft bill (Title I) would also create new patent and non-patent exclusivity opportunities. Continuing a trend of “exclusivity stacking” started in 1997 with the creation of 6-month pediatric…
…‘952 patent and confirm the company’s eligibility for 180-day exclusivity based on its Paragraph IV certification to the patent. FDA states in its petition response that according to the Agency’s…
…505(b)(2) NDA applicants is at 21 C.F.R. § 314.60(f).) This regulation states: (d)(1) Patent certification requirements. An amendment to an ANDA is required to contain an appropriate patent certification or…
…covering OMNICEF (cefdinir) has been discussed at length in the blogosphere for its possible implications on the future of product-by-process patents (see e.g., Patent Baristas and Patent Docs). The court’s…
…viii statement for a method of use patent vulnerable to patent litigation. As the RLD holder, GSK had listed several patents in the Orange Book for carvedilol (Coreg), initially approved…
…the average difference in patent strengths rather than any payment for delay. Similarly, patent settlements with and without reverse payments may differ in the average patent life remaining or the…
…but only recently served, the Genetics & IVF Institute (“GIVF”) is challenging the PTO’s August 2010 denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,135,759 (“the ‘759…
…suspect that FDA agreed to award Ferring 5-year NCE exclusivity for PREPOPIK. That also very likely means that any other similarly situated NDA holder will be awarded NCE exclusivity, such…
…Extended-Release Tablets, 25mg, which was submitted to FDA in December 2003. Sandoz was a “first applicant” eligible for 180-day exclusivity based on its Paragraph IV certification to a patent listed…
…has “a Constituionally-protected interest” in the orphan drug exclusivity FDA granted for WILATE, and that FDA may not rescind exclusivity without providing the company an opportunity to defend its exclusivity…
…paragraph IV certification to the ‘051 patent. Therefore, with this approval, Sun is eligible for 180-days of generic drug exclusivity for Imatinib Mesylate Tablets, 100 mg (base) and 400 mg…
…NCE exclusivity, says: The 5-year NCE exclusivity provision clearly contemplates a single date of approval for determining when an exclusivity period begins. The bar clause prevents the submission of any…