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Your search for “patent exclusivity” returned the following results.
…temporary, preliminary, and permanent declaratory and injunctive relief to “restore” Plaintiffs’ orphan drug exclusivity for MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL. FDA approved MAKENA on February 3, 2011 under NDA…
…exclusivity could be longer. FDA hopes that this period of market exclusivity will provide an incentive to firms to be the first to obtain approval to market a previously unapproved…
…FOBs. The report comes at a time when Congress is poised to consider FOB legislation (see our previous posts here and here) with varying periods of market exclusivity and patent…
…Apotex to immediate approval. Pediatric exclusivity will continue to bar approval of Apotex’s ANDA until Apotex affirmatively wins its patent litigation, with a final effective decision that the patent is…
…the biosimilar product.” Amgen devotes a couple of pages of its brief to distinguishing between marketing exclusivity and data exclusivity, saying that the BPCIA does not protect brand name products…
…FDA in March 2005 with paragraph IV certifications to two Orange Book-listed patents covering DEPAKOTE: U.S. Patent #4,988,731 (“the ‘731 patent”) and #5,212,326 (“the ‘326 patent”). These patents expired on…
…been included because some may have argued that if there was patent protection for an orphan drug, there would be no need for the 7 years of orphan drug exclusivity)….
…in the Notice letters made publicly available. While I’m not a patent lawyer, these patents appear to be mostly device patents, which signals that FTC not only thinks REMS patent-listings…
…the bill last week by the House Committee on the Judiciary would give The Medicines Company (“MDCO”) some legislative assurance of a Patent Term Extension (“PTE”) for U.S. Patent No….
…Orange Book-listed patents – U.S. Patent Nos. 6,200,604 (the ‘604 Patent) and 6,974,590 (the ‘590 Patent) – both of which are scheduled to expire on March 26, 2019. Cephalon filed…
…Pharmaceutical Industries Ltd., and Hospira Inc. – stemming from their Paragraph IV certifications to U.S. Patent No. 5,338,874 (“the ‘874 patent”) listed in the Orange Book as covering ELOXATIN. Fast…
…receive and publish certain patent infringement lawsuit complaints in the Federal Register. Tying up with a bow its determination to stay clear of patent dance fights to the extent possible,…
…litigation over the BPCIA’s information exchange and patent resolution provisions, but weighs in for Amgen in an amicus brief. According to AbbVie, absent a reversal of Judge Seeborg’s decision, biosimilars patent…
…Patent No. 7,101,574 (“the ‘574 patent“) covering ANTARA (fenofibrate) Capsules, which is approved under NDA No. 21-695, and granted a Motion to Dismiss filed by defendants Ethypharm S.A., Lupin Limited,…
…include patent certifications to patents listed in the Orange Book for COLCRYS). As we previously posted (, here, , and ), Takeda and Elliott unsuccessfully sued FDA in October 2014 alleging…