- Last Monday, the Federal Circuit affirmed a district court decision in McNeil-PPC v. Perrigo, concerning a generic version of Pepcid Complete. The decision was affirmed without an opinion, under Rule 36.
- Tuesday, AstraZeneca and Ranbaxy announced a settlement of their patent litigation over generic Nexium (esomeprazole), with Astra granting Ranbaxy exclusive rights to sell a generic version of Nexium in 2014, six months before the first patent expires. Teva and Dr. Reddy’s plan to continue challenging Astra’s patents. Astra press release; Ranbaxy press release; AP; Bloomberg; Pharmalot; WSJ Health Blog.
- In a very surprising decision, a D.C. district court recently ruled in favor of Teva in a case in which Teva alleged that the FDA wrongfully delisted a patent on Risperdal (risperidone) from the Orange Book, depriving Teva of 180-day exclusivity. FDA Law Blog has a full report.
- Earlier this month, Depomed announced a settlement of patent litigation
against Teva over generic Glumetza (metformin HCl). Depomed
press release; AP story. - Pharmalot recently had two interesting posts about biosimilars: the first suggested, based on a report about the Food and Drug Law Institute’s annual meeting, that biosimilars legislation may actually be passed this year; the second reported on lobbying for a biosimilars bill.
- FDA Law Blog recently updated their coverage of the generic Depakote (divalproex sodium) litigation between Nu-Pharm (a former subsidiary of Apotex) and FDA, in which Nu-Pharm is seeking an injunction requiring FDA to grant final approval to its divalproex ANDA.
- Pharmalot posted a summary of a recent article in the Seattle Post-Intelligencer about a citizen petition that has stymied Nastech Pharmaceutical’s bid to market a generic version of Miacalcin (calcitonin), a treatment for postmenopausal osteoporosis.
- Takeda announced earlier this month that on March 31, the Supreme Court denied Alphapharm’s cert petition from the Federal Circuit’s decision last year in the Actos (pioglitazone) litigation.
Posted in 180-Day Exclusivity, Citizen Petitions, FDA Litigation, Orange Book Issues, Paragraph IV Cases
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