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Your search for “patent exclusivity” returned the following results.
…denied PhotoCure’s application for a Patent Term Extension (“PTE”) for U.S. Patent No. 6,034,267 (“the ‘267 patent”) covering the human drug product METVIXIA (methyl aminoevulinate hydrochloride), which FDA approved on…
By Kurt R. Karst – On March 7th, the U.S. Supreme Court denied yet another Petition for Writ of Certiorari concerning whether patent settlement agreements (what opponents call “pay-for-delay” agreements…
…included in the Orphan Drug Act, to develop or otherwise obtain marketing exclusivity for antibiotics that treat serious and life-threatening infectious diseases; and (3) Section 1113, titled “Exclusivity of certain…
…6-month extension of exclusivity periods – what we’ve referred to as “exclusivity stacking” – for a drug approved for a new indication for a rare disease or condition (i.e., so-called…
…an initial 12-year exclusivity period that may be extended by 6 months of pediatric exclusivity. In addition, the 12-year exclusivity period would not be available with respect to the approval…
…Prescription Drug Product List and to the Patent and Exclusivity Data Addendum for NDA 020357: Why were the dates changed to March 3, 1995 and March 3, 2000? Apparently when…
By Kurt R. Karst – That’s the picture conjured up when we plugged some dates into the new model for calculating forfeiture of 180-day generic drug marketing exclusivity for certain…
…hours). PRISTIQ is listed in the Orange Book with a single patent – U.S. Patent No. 6,673,838 (“the ‘838 patent”) expiring on February 11, 2022. PRISTIQ is also identified in the…
…the end of the NDA holder’s period of marketing exclusivity for the brand name drug before there is generic competition, or with a generic applicant’s 180-day exclusivity. The Analysis Group…
…of patent infringement claim in which the value paid by the NDA holder to the ANDA filer as a part of the resolution or settlement of the patent infringement claim…
…approval while omission of eligible patents, and subsequent litigation on those patents, prolongs launch. Several comments just wanted more information included in the Orange Book about both the patents and…
…request for a Patent Term Extension (“PTE”) for U.S. Patent #4,916,154 (“the ‘154 patent”). The ‘154 patent covers Wyeth’s new animal drug CYDECTIN (moxidectin) Pour-On. Earlier today, the District Court…
…contains a paragraph IV certification to a later-listed patent and the NDA holder or patent owner has sued the ANDA applicant for patent infringement as a result of notice of…
…Entity (“NCE”) exclusivity. Because patents are listed in the Orange Book for SAMSCA, that raises the possibility of submission of an ANDA containing a Paragraph IV certification beginning on the…
…Street Journal last year – here.) According to the FTC, the Commission received 156 final resolutions of patent disputes between a brand and a generic in Fiscal Year 2011. …