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Your search for “patent exclusivity” returned the following results.
…unexpired non-patent exclusivity for COLCRYS, as well as information on several patents that expire in 2028 and 2029. The MITIGARE NDA does not cite COLCRYS as a listed drug relied…
…create Hatch-Waxman benefits for old antibiotics. Under a transition provision included in the QI Act, NDA holders and patent owners can list patents in the Orange Book, and generic applicants…
…skinny labeling FDA letter to USPTO / GW Roundtable (patent listings, patent prosecution, patent thickets/evergreening, and more) Catalyst and orphan drug exclusivity 180-day exclusivity and potential BLOCKING Act Biologics transferred…
…the patent and non-patent market exclusivity provisions of follow-on biologic legislation that has been introduced. The CBI conference is intended to provide participants with the opportunity to evaluate follow-on biologic…
…should be an abbreviated review process for medical devices. In an essay titled “When Patents Aren’t Enough: Why Biologics Necessitate Data Exclusivity Protection” Kristina M. Lybecker, Associate Professor of Economics…
…pediatric exclusivity associated with U.S. Patent No. 5,006,528 expires) based on FDC Act § 505A(o) (concerning the inclusions and omission of protected pediatric information in generic drug labeling) and the…
…debate on the FDA bill and proposed to amend the FDC Act’s provisions with respect to “first applicant” status and 180-day marketing exclusivity for certain ANDA sponsors to address patent…
…Orange Book. (Recently, the ANDA sponsor settled the patent infringement litigation with Elan. Under the settlement agreement, the generic will not be marketed until either patent expiration or if there…
…in Sandoz v. Amgen, leaves two relevant avenues for Amgen to secure process information from Hospira: sue for infringement of the patents included on the patent list exchanged with Hospira…
…Single-Dose Therapy use is covered by U.S. Patent No. 5,756,506 (“the ‘506 patent”), which expires on June 27, 2015, and claims the use of enrofloxacin in a single high dose…
…Herb Kohl’s (D-WI) Preserve Access to Affordable Generics Act (S. 27) concerning patent settlement agreements (or what opponents call “pay-for-delay” or “reverse payment” agreements). The latest iteration of the Preserve Access…
…IV to a patent listed in the Orange Book for the listed drug relied on, or RLD, must provide notice of that certification to the NDA sponsor and patent owner. …
…Amgen are locked in patent litigation that has raised the issue of whether and how the complicated patent dance provisions of the BPCIA applies (see our previous posts here, here, here…
…of a Section 505(b)(2) applicant’s patent certification obligation is clear on the face of the statute: such applicant need only certify to the product patents or the method-of-use patents that…
…Book “is claimed by a use patent.” Mitigare’s label contained an indication for “prophylaxis of gout flares.” Takeda’s Colcrys® use patents are listed in the Orange Book as claiming that…