Month: June 2006
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In response to an emergency motion for preliminary injunction enforcement filed by Abbott Laboratories on June 26 in the U.S. District Court for the Northern District of Illinois, Teva Pharmaceuticals USA, Inc. announced on June 27 that it will cease sales of a generic version of Abbott's Biaxin XL (clarithromycin extended release), which Teva had…
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In response to the Supreme Court's denial of certiorari in FTC v Schering earlier this week, four senators introduced Senate bill S3582 yesterday, which seeks to prohibit brand name drug companies from entering into "reverse payment" settlements with generic drug companies. In FTC v. Schering, the FTC had petitioned the Court to decide whether a reverse…
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The Supreme Court this morning denied review of FTC v. Schering, without comment. The FTC had petitioned the Court to decide whether a "reverse payment" settlement from an innovator drug company to a generic drug maker in a Hatch-Waxman case violated the antitrust laws. Denial by the Supreme Court leaves standing an Eleventh Circuit ruling…
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The FDA recently appealed the district court case that forced it to make a decision on Sandoz’s drug application for Omnitrope, which later led to FDA to approve Omnitrope. Sandoz has called Omnitrope the first ever biogeneric drug. In a decision on April 10, the U.S. District Court for the District of Columbia held, on…
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The FDA today granted final approval to Ivax and Ranbaxy to market generic versions of Zocor (simvastatin). Additionally, it appears the FDA has granted generic marketing exclusivity to Ivax and Ranbaxy for the next 180 days. The FDA approval comes despite a last-ditch effort by Novartis subsidiary Sandoz to prevent the FDA from granting final…
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In a 31-page opinion by Judge Prost, joined by Judge Gajarsa, a Federal Circuit panel held yesterday that Teva had raised a substantial question as to the validity of Abbott’s patents covering its extended release clarithromycin product, Biaxin XL, and therefore vacated a preliminary injunction that had been entered against Teva by the U.S. District…
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Bloomberg News is reporting tonight that Sandoz, the generics arm of Novartis AG, filed a request for a temporary restraining order today in an attempt to prevent the FDA from granting Ivax and Ranbaxy final approval tomorrow to market generic Zocor (simvastatin). The motivation behind Sandoz’s eleventh hour request is not entirely clear, especially because…
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In advance of Merck’s patent on Zocor expiring tomorrow (Friday), and the expected launch of generic versions of Zocor by Ivax (a Teva unit) and Ranbaxy, Merck has made deals with some insurance companies to sell branded Zocor for less than Ivax and Ranbaxy planned to charge for their generics. Teva’s stock price dropped about…
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After a Massachusetts drug company missed–by a single day–a non-extendable deadline for filing for a patent term extension, H.R. 5120 was recently proposed in the U.S. House of Representatives to amend 35 U.S.C. 156, the statute governing patent term extensions based on regulatory review delay. Some people are calling H.R. 5120 the "Dog Ate My…
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