Menu
Your search for “patent exclusivity” returned the following results.
…as to why S.B. 539 is unconstitutional. First, PhRMA and BIO argue that S.B. 539 is preempted by federal patent law because S.B. 539 “impermissibly burdens” manufacturers’ patent rights by…
…the presumption of illegality] if the settlement allowed no generic competition until patent expiration.”). Significantly, DOJ explicitly states: “That is so even if the parties believed that the patentee would…
…challenged patent(s) is invalid, unenforceable, or not infringed. If the NDA holder or patent owner timely brings suit, then clearance of the 510(k) or approval of the PMA for the…
…180-day exclusivity eligibility so that certain subsequent ANDA applicants could trigger and be eligible for exclusivity. Rep. Hastings initially proposed his bill as an amendment to the House Health Care…
…only will transitioning products lose exclusivity, those that are deemed to be licensed under the Public Health Service Act won’t be eligible for a 12-year period of reference product exclusivity….
Earlier today, FDA issued its decision with respect to amlodipine generics and the applicability of Mylan’s 180-day exclusivity and Pfizer’s pediatric exclusivity. The U.S. District Court for the District of…
…eligibility for 180-day exclusivity for Valganciclovir Tablets pursuant to FDC Act § 505(j)(5)(D)(i)(IV) because Ranbaxy failed to obtain timely tentative approval within 30 months of ANDA submission. As we previously…
…for 3-year exclusivity because of the limitation on such exclusivity for a so-called “old antibiotics” like vancomycin set forth in FDC Act § 505(v) as added by Section 4 of…
…drug exclusivity is limited to the indications or uses for which the designated drug is approved (21 C.F.R. § 316.31(a) and (b)); and (9) Clarified that a designated drug that…
…PBOS to submit appropriate amendments to their abbreviated new drug applications. If FDA grants Teva marketing exclusivity, the scope of that exclusivity may affect the labeling that could be approved…
…in a lawsuit initiated with a September 2012 Complaint (see our previous post here) and ordered FDA to recognize orphan drug exclusivity for GRALISE (gabapentin) Tablets “without requiring any proof…
…Camp program in 2016. Titled “Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute,” Mr. Karst will deconstruct, in a step-by-step manner, a complex exclusivity dispute, analyzing…
…a complex exclusivity dispute, analyzing FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity. Relevant court decisions will also be analyzed and their practical and future effects…
…will deconstruct, in a step-by-step manner, a complex exclusivity dispute, analyzing FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity. Relevant court decisions will also be analyzed…
…of 2017 shall continue to apply. The changes above would reflect FDA’s current and long-standing interpretation of the statute – that to obtain a period of orphan drug exclusivity for…