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  • The Orange Book blog team are a group of attorneys with McAndrews, Held and Malloy, which is a full-service IP firm representing both brands and generics in various aspects of IP law. This blog does not provide legal advice. If you are seeking legal advice, please contact the author directly.

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July 12, 2006

Sandoz's Motion for Preliminary Injunction to Delay FDA Approval of Generic Zocor is Denied

The District Court for the District of Columbia today denied Sandoz's motion for a preliminary injunction, filed June 22, 2006, to delay final FDA approval of Teva and Ranbaxy's generic versions of Zocor.  Previously, the same court denied Sandoz's request for a temporary restraining order.  The FDA granted final approval to Teva and Ranbaxy on June 23, 2006, and the companies launched their products shortly thereafter.

In today's opinion, the district court wrote that Sandoz's motion failed on each of the four factors:  likelihood of success on the merits, irreparable harm, balance of interests, and the public interest.

Earlier this year, the FDA appealed a separate decision by the same district court that required the FDA to grant final approval to Teva and Ranbaxy upon expiration of Merck's final orange book listed patent on Zocor.

NOTE:  thanks to Kurt Karst for sending us a copy of today's opinion.

Posted by in Orange Book Issues |

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