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Your search for “patent exclusivity” returned the following results.
…7,803,840 (“the ‘840 patent”), 7,320,999 (“the ‘999 patent”), and 6,509,376 (“the ‘376 patent”). These patents are listed in the Orange Book for the blockbuster drug TECFIDERA (dimethyl fumarate) delayed-release capsules,…
…FDA issued its response after soliciting public comment on whether Teva forfeited 180-day exclusivity eligibility because the only exclusivity-qualifying patent – U.S. Patent No. 5,608,075 (“the ‘075 patent”), which was…
…of 180-day exclusivity. Under FDA policy: an ANDA applicant who has obtained 180-day exclusivity may relinquish its exclusivity entirely or selectively waive the exclusivity in favor of a single ANDA,…
…inadequate, the CDER Exclusivity Board once again earlier this year had to assess the scope of 3-year exclusivity – in this case for XTAMPZA ER – and whether that exclusivity…
…addition to any 6-month pediatric exclusivity extension in effect. Ahh . . . but there’s more . . . . In addition to applying to non-patent exclusivity the conveyed exclusivity…
…exclusivity extends by 6 months Orange Book-listed patent and non-patent exclusivities, and in particular, the period of NCE exclusivity for INVEGA until June 19, 2012. Shortly before the time FDA granted…
…see the harshest exclusivity-related provisions. It provides as follows: (a) TERMINATION OF EXCLUSIVITY.—Notwithstanding any other provision of this Act, any period of exclusivity described in subsection (b) granted to a…
…patent”), and 6,894,064 (“the ‘064 patent”) (all expiring on March 10, 2017). A fourth patent – U.S. Patent No. 8,030,330 (“the ‘330 patent”), also expiring on March 10, 2017 –…
…earlier. The Orange Book lists three patents for CONCERTA: U.S. Patent Nos. 6,919,373 (“the ‘373 patent”), 6,930,129 (“the ‘129 patent”), and 8,163,798 (“the ‘798 patent”). 180-Day exclusivity with respect to…
…when the Medicare Modernization Act (“MMA”) was enacted. As such, 180-day exclusivity is governed by the pre-MMA version of the FDC Act, where exclusivity is patent-by-patent. Apotex submitted ANDA No….
…exclusivity expiration date was, in fact, October 16, 2008.) No patents were listed in the Orange Book for ELESTAT until Friday, October 10, 2008, when the ‘602 patent, which was…
…lists three unexpired periods of non-patent exclusivity for ABILIFY Tablets, ABILIFY Oral Solution, ABILIFY DISCMELT Orally Disintegrating Tablets, and ABILIFY Injection, which expire on December 12, 2021 (orphan drug exclusivity),…
…Kabi USA, LLC (“Fresenius”) to remove a patent – U.S. Patent No. 6,992,218 (“the ‘218 patent”) – from the Orange Book listed by Cadence Pharmaceuticals (“Cadence”) for OFIRMEV (acetaminophen) Injection. …
…by the pre-Medicare Modernization Act (“MMA”) version of the statute, under which exclusivity is patent-by-patent and can be shared by cross-Paragraph IV filers to different patents. At the time the…
…Extended Release Tablets, 4mg and 2mg. (The other patents are U.S. Patent Nos. 5,382,600 (“the ’600 patent”), 6,630,162 (“the ‘162 patent”), and 6,770,295 (“the ‘295 patent”), which expire on March…