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Your search for “patent exclusivity” returned the following results.
…of a patent term extension). Section 4(b)(1)of the QI Act includes three transition provisions: one on Orange Book patent listing; one on patent certifications; and another on 180-day exclusivity for…
…paragraph IV patent certification with respect to U.S. patent #4,847,265 (“the ‘265 patent”). The ‘265 patent is listed in the Orange Book with other patent and non-patent market exclusivities as…
…certification to four Orange Book-listed patents covering ARICEPT – U.S. Patent Nos. 5,985,864 (“the ’864 patent”); 6,140,321 (“the ’321 patent”); 6,245,911 (“the ’911 patent”), and 6,372,760 (“the ’760 patent”) (collectively…
By Kurt R. Karst – In a series of letters, the U.S. Patent and Trademark Office (“PTO”) has clarified when patents covering certain drug products are eligible for a Patent…
…day, thereby preserving NCE exclusivity for NDA No. 022271, and allowing that NCE exclusivity to apply under the Agency’s “umbrella exclusivity policy” to the other two approved NDAs. According to…
…for NCE exclusivity. Instead, FDA awarded 3-year exclusivity, as Amarin announced last Friday. In a nutshell, FDA’s rationale for denying NCE exclusivity is that eicosapentaenoic acid (“EPA”), “the single active…
…FDA granted for DALVANCE is the latest expiring period of non-patent exclusivity ever listed in the Orange Book (not to mention the longest period of exclusivity that FDA has granted…
…exclusivity as it existed prior to the December 2003 enactment of the Medicare Modernzation Act (“MMA”), when exclusivity was patent-by-patent and was triggered by the earlier of first commercial marketing…
…patent”). Teva argued that the ‘952 patent was incorrectly removed from the Orange Book after the company submitted an ANDA with a Paragraph IV certification to the patent, because the…
…EXCLUSIVITY DETERMINATION NEEDED? PART II – FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES PART III – THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS Changes in the law and the need for greater…
…Paragraph IV 180-day exclusivity. But that’s about where the similarity ends, as FDA has opined in a new Letter Decision concerning CGT 180-day exclusivity for Potassium Chloride Oral Solution USP,…
…patent for the reference listed drug, AVODART. Specifically, ANDA No. 090095 was considered received by FDA as of October 29, 2007 with Paragraph IV certifications to the three listed patents on AVODART. Patent…
…light of a recent Citizen Petition decision (Docket No. FDA-2015-P-0403). Orange Book Patent and Exclusivity Information Addendum FDA makes several noteworthy revisions to the Patent and Exclusivity Information Addendum, which…
…information on the patent within 30 days of issuance of the patent, an applicant who submitted an [ANDA] for that drug that contained an appropriate patent certification before the submission…
…of reason” analysis. Under the scope of the patent test, “reverse payments are permitted so long as (1) the exclusion does not exceed the patent’s scope, (2) the patent holder’s…