Twin victories for Roxane Laboratories
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.
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
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
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.