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Schering Suit Triggers 30-Month Stay Of Action On Clarinex ANDAs

This article was originally published in The Pink Sheet Daily

Executive Summary

More than a dozen generic drug makers face patent infringement suits.

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Schering-Plough's Clarinex and Savient's Oxandrin Challenged By Paragraph IV Certifications

Schering-Plough's antihistamine franchise is facing Paragraph IV challenges. An ANDA for Clarinex(desloratadine) 5 mg tablets, as well as 2.5 mg and 5 mg orally disintegrating tablets, was filed on June 21. An ANDA was also filed for Clarinex-D 24 Hour extended release 5 mg/240 mg tablets. Clarinex 5 mg tablets and the orally disintegrating formulations are protected with a patent through Jan.7, 2020, including a pediatric extension, while patent protection for the extended release 5 mg/240 mg version runs through March 28, 2022, according to the "Orange Book." ANDAs with Paragraph IV certifications have also been filed for Savient's oral anabolic agent Oxandrin(oxandrolone) tablets 2.5 mg and 10 mg tablets. Both formulations are protected by patents through Dec. 5, 2015

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