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Your search for “patent exclusivity” returned the following results.
…for generic metaxalone in light of certain patent-protected language in the labeling of the RLD,” and, as a result, 180-day exclusivity was not forfeited. As we previously discussed, the citizen…
…to approval” criterion is one of the three criteria that must be met for FDA to grant 3-year exclusivity. Similar to ViroPharma’s challenge to FDA’s exclusivity decision, Judge Huvelle found…
…inadequate generic competition (not more than one approved drug in the active section of the Orange Book), but not eligible for CGT exclusivity if a patent or exclusivity is listed…
…incentivize applicants to challenge patents by preserving (in many instances) the opportunity to obtain 180-day exclusivity. In the case of forfeiture of 180-day exclusivity eligibility for generic ACTONEL Tablets, 150…
…last August challenging FDA’s April 2014 denial of a Citizen Petition (Docket No. FDA-2013-P-0884) requesting that the Agency conclude that the 5-year New Chemical Entity (“NCE”) exclusivity start dates for Eisai’s BELVIQ (lorcaserin HCl) Tablets (NDA…
…on behalf of Actavis supporting the company’s position that FDA erroneously awarded 5-year NCE exclusivity to VYVANSE. According to that letter brief: In granting NCE exclusivity to Vyvanse, FDA appears…
…end counting). Under FDC Act § 505(j)(5)(D)(i)(IV), which is one of the six 180-day exclusivity forfeiture provisions added to the FDC Act by the 2003 Medicare Modernization Act, 180-day exclusivity…
…might approve ANDAs for generic versions of ABILIFY come April 20, 2015 when the period of pediatric exclusivity associated with U.S. Patent No. 5,006,528 (listed in the Orange Book as…
…drawing revenues away from generic firms during the 180-day exclusivity period provided for first-filers that challenge a brand-name company’s patents. They caution that this reduces the potential reward available to…
…Apotex’s decision to take the risk of going to market before the patent infringement suit was decided, Astra should lose all the benefit of the pediatric exclusivity period it earned…
…what is the new law permitting Hatch-Waxman benefits? Enantiomer exclusivity – what are the new rules permitting 5-year exclusivity? How is FDA interpreting the 180-day exclusivity forfeiture provisions and when…
…exclusivity and patent listing in that FDA reverse that position[; and] 2. . . . list the patent submitted for the Medicis product Zianaä and acknowledge the 3-year period of…
…ADDERALL XR is governed by the pre-Medicare Modernization Act version of the FDC Act where exclusivity is patent-by-patent and product-by-product. Exclusivity with respect to the ‘819 and the ‘300 patents…
…same reference listed drug and all containing paragraph IV certifications challenging a patent for the reference listed drug. No applicant has previously challenged the patent. Of these three ANDAs, the…
…in its Complaint. Notwithstanding the alleged absence of certain information from Hospira, Amgen engaged Hospira in the patent exchange process of the patent dance. But Amgen says that Hospira has…