Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

Category: Paragraph IV Cases

  • Novartis Wins Temporary Restraining Order Against Teva in Lotrel Case

    Novartis v. Teva, No. 04-4473 (D.N.J. 2007) More drama involving amlodipine–this time with Lotrel (made by Novartis), rather than Norvasc (made by Pfizer).  Lotrel contains a combination of two active ingredients–amlodipine besylate and benazepril–whereas Norvasc contains only one.  Both drugs are indicated for the treatment of high blood pressure and both are blockbusters. Teva announced…

  • Pharma News Briefs

    In a May 14 Order, the district court in D.C. denied all motions for reconsideration of its April 30 decision on Norvasc pediatric and 180-day exclusivity.  FDA Law Blog has all the reconsideration briefs.  Apotex and Mylan have now appealed to the D.C. Circuit. The In Vivo Blog reports that "Democratic and Republican staffers involved…

  • Eisai Defeats Dr. Reddy’s and Teva in Aciphex Patent Suit

    Eisai v. Dr. Reddy’s and Teva, Nos. 03-9053 and 03-9223 (S.D.N.Y. 2007) Eisai owns U.S. Patent No. 5,045,552, which claims the chemical compound rabeprazole sodium, the active ingredient in Eisai’s blockbuster proton-pump inhibitor Aciphex.  Dr. Reddy’s, Teva and Mylan filed ANDAs for generic Aciphex with paragraph IV certifications to the ‘552 patent.  Aciphex has annual…

  • Federal Circuit Affirms Validity of Janssen’s Risperdal Patent, Rejecting Mylan’s Obviousness Arguments

    Janssen Pharmaceutica et al. v. Mylan Pharms., No. 07-1021 (Fed. Cir. 2007) Last Thursday, the Federal Circuit heard oral arguments in Mylan’s appeal of a district court decision upholding the validity of Janssen Pharmaceutica’s patent on Risperdal (risperidone), an antipsychotic medication with over $2 billion in annual U.S. sales.  On Friday, the Federal Circuit affirmed…

  • Pharma News Briefs

    AP published this report on yesterday’s House hearing on "reverse payment" settlements. AP also recently published this article on follow-on biologics legislation, entitled "Time is Running Out for Generic Biotech." Antitrust Review recently posted an update on the FTC’s authorized generics study. FDA Law Blog has a new post today on the most recent developments…

  • District Court Denies All Challenges to FDA Decision on Norvasc Exclusivity; Generic Cos. Likely to Appeal

    Mylan Labs. et al. v. Leavitt et al., No. 07-579 (D.D.C. 2007) In an April 18 decision, the FDA determined that Pfizer is entitled to six months of pediatric exclusivity on Norvasc (amlodipine besylate), that Mylan may continue to sell its generic version of Norvasc, that FDA will approve Apotex’s generic Norvasc ANDA if and…

  • Mylan, Apotex, and Teva File Motions Challenging FDA’s Decision on Generic Norvasc

    Apparently not too many companies other than Pfizer are happy with the FDA’s decision last week regarding Norvasc (amlodipine besylate) exclusivity.  On Monday, Mylan, Apotex, and Teva all filed motions with the U.S. District Court for the District of Columbia for injunctive relief from FDA’s decision.  Today, everyone filed briefs in opposition to each others’…

  • Purdue Pharma Tries to Salvage 30-Month Stay in OxyContin Case Against Mallinckrodt

    Purdue Pharma has been fighting in court for nearly a decade to protect OxyContin–a blockbuster painkiller and by far Purdue’s best-selling drug product–from generic competition.  Purdue settled its patent litigation with Endo and Teva last year, and with Impax a few weeks ago.  Recently, Purdue filed complaints against Mallinckrodt and KV Pharma.  Purdue’s case against…

  • Abbott Wins Preliminary Injunction Against Sandoz in Biaxin XL Case

    Abbott Labs v. Sandoz, No. 05-5373 (N.D. Ill. 2007) This past Monday, Judge David H. Coar of the U.S. District Court for the Northern District of Illinois granted Abbott’s motion for a preliminary injunction to stop Sandoz from selling a generic version of Biaxin XL (clarithromycin extended release tablets).  Abbott earns about $300 million each…

  • FDA Refuses to Approve Any ANDAs for Generic Norvasc Besides Mylan’s–For Now

    Ever since March 22, when the Federal Circuit invalidated claims 1-3 of Pfizer’s last remaining unexpired patent on Norvasc–U.S. Patent No. 4,879,303–Pfizer, Mylan and other ANDA filers have been scrambling.  On March 23, Mylan, the first ANDA filer, launched its generic version of Norvasc and Pfizer responded by launching an authorized generic.  On March 26,…