Twin victories for Roxane Laboratories

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Zuckerman Spaeder has long been an advocate for generic pharmaceutical manufacturers, and two victories for client Roxane Laboratories illustrate the strength of the firm’s food and drug team.

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The cases involve Fluticasone, a generic version of Flonase, and Acarbose, a generic Type II diabetes drug. Both cases were featured in The American Lawyer and cited in the firm’s recognition as a Litigation Boutique of the Year finalist.

2006: Flonase and GlaxoSmithKline

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Immediately after the Food and Drug Administration (FDA) approved Roxane’s generic verison of the multibillion dollar nasal inhaler Flonase® (active ingredient fluticasone), Flonase’s® manufacturer, GlaxoSmithKline, obtained a TRO blocking the approval and preventing our client from marketing its lower-priced generic fluticasone product.

The Zuckerman Spaeder team intervened in the case on behalf of Roxane and successfully defeated GSK’s motion for a preliminary injunction, upholding  FDA’s approval of Roxane’s product.
Zuckerman Spaeder also obtained a $3 million payment as compensation for lost profits during the TRO that prevented the FDA from approving our client’s product.

2008: Precose and Cobalt

In the first case testing the generic exclusivity forfeiture provisions ‎of the Federal Food, Drug and Cosmetic Act, the FDA had approved Roxane’s application for a ‎generic version of the drug Precose®, used to treat Type II diabetes, after ‎concluding that Roxane’s competitor Cobalt Laboratories Inc. had forfeited its right to 180 ‎days of generic exclusivity by failing to market its product within 30 months of submitting its ‎application.

Cobalt, however, claimed it was still entitled to 180-day exclusivity and sought a TRO that would have required Roxane, which had already ‎secured 65 percent of the market, to immediately stop selling its FDA-approved product ‎while Cobalt remained on the market.

The Zuckerman Spaeder food and drug team convinced the U.S. District Court for the District of Columbia ‎to deny the TRO. Cobalt voluntarily dismissed the case rather than pursuing a preliminary ‎injunction.

A victory for patients

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With health care costs soaring across the country, these were victories for both ‎Roxane and American consumers, who benefit from vigorous competition in the generic ‎pharmaceuticals marketplace.

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