Orange Book Blog

At the intersection of Patent and FDA Law

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Category: 180-Day Exclusivity

  • Dismissal of Invalidity Counterclaims Thwarts Apotex’s Attempt to Trigger 180-Day Exclusivity on Cosopt

    Merck v. Apotex, No. 06-5789 (D.N.J. 2007) Merck has sold Cosopt (dorzolamide hydrochloride/timolol maleate), an opthalmic drug indicated for the treatment of ocular hypertension and open-angle glaucoma, since 1998.  In October 2005, Hi-Tech Pharmacal filed the first ANDA for a generic version of Cosopt with paragraph IV certifications to the Orange Book-listed patents: U.S. Patent…

  • Pharma News Briefs

    King Pharmaceuticals filed its 10-Q statement with the SEC on Friday, revealing that Cobalt Pharmaceuticals, the first ANDA filer for Altace (ramipril), recently notified King of its intent to launch its generic ramipril product, notwithstanding the settlement agreement between the two parties (see pages 12 and 20 of King’s 10-Q filing). Ranbaxy submitted new comments…

  • FDA’s Request for Comments on Ramipril 180-day Exclusivity Draws Letters from Eight Generic Companies

    King Pharmaceuticals markets Altace (ramipril), a treatment for high blood pressure with nearly $1 billion in annual U.S. sales.  U.S. Patent No. 5,061,722, owned by Aventis and licensed to King, is listed in the Orange Book for Altace. Cobalt Pharmaceuticals submitted the first ANDA with a paragraph IV certification to the ‘722 patent in 2002,…

  • Pharma News Briefs

    FDA recently posted numerous comments from industry regarding Ramipril 180-day exclusivity issues on its website.  The comments come in response to FDA's request last month.  A summary of the new comments is in the works. FDA also established a docket for comments on Granisetron HCl 180-day exclusivity issues.  This too follows an FDA request made…

  • Pharma News Briefs

    Last Friday, FDA Law Blog wrote about yet another 180-day exclusivity letter from the FDA, this one requesting comment on the "failure to market" forfeiture provisions of the MMA. FDA Law Blog also posted a very nice summary of the FDA Amendments Act, which, among other changes, revises the citizen petition process. GSK sued the…

  • FDA Requests Comments on 180-Day Exclusivity for Generic Altace (Ramipril)

    For the second time in as many weeks, FDA has asked interested parties to submit comments regarding 180-day generic drug exclusivity issues.  On September 26, as FDA Law Blog reported, FDA requested comments on exclusivity for generic Precose (acarbose) tablets; last week, FDA asked for comments on exclusivity for generic Altace (ramipril) capsules.  Two letters…