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FOR IMMEDIATE RELEASE:
May 19, 2008
Sarah Fait, (202) 778-8439, email@example.com
ZUCKERMAN SPAEDER WINS FIRST CASE TESTING
GENERIC EXCLUSIVITY FORFEITURE RULES
May 19, 2008—
Zuckerman Spaeder LLP client Roxane Laboratories, Inc.
secured an important victory in the first case testing the generic exclusivity forfeiture provisions
of the Federal Food, Drug and Cosmetic Act (FDCA). In a May 9 ruling, the United States
District Court for the District of Columbia declined to issue a temporary restraining order that
would have forced Roxane to stop marketing its just-approved version of the drug acarbose, used
to treat Type II diabetes. On May 16, the case was voluntarily dismissed by the plaintiff, Cobalt
“This is not just a victory for Roxane, but in this time of soaring healthcare costs it is also a
victory for American consumers, who will benefit from vigorous competition in the generic
pharmaceuticals marketplace,” said Zuckerman Spaeder partner William B. Schultz.
In the suit, Cobalt challenged the decision of the Food and Drug Administration (FDA) to
approve Roxane’s application for acarbose at the same time as it approved Cobalt’s application.
FDA had approved Roxane’s application after concluding that Cobalt 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. Roxane
intervened to protect its interest in the case.
Cobalt sought an order that would have required Roxane to stop selling its product while Cobalt
remained on the market. In its ruling, the court agreed with FDA and Zuckerman Spaeder that,
under the plain language of the FDCA, Cobalt was unlikely to prevail in the case and also that
Roxane would suffer significant competitive injury from a temporary restraining order. Mr.
Schultz, on behalf of Roxane, advocated that the temporary restraining order requested by Cobalt
be denied because it would not freeze the “status quo”; rather, it would allow Cobalt to secure
significant market advantages as the only generic seller of acarbose.
“The impact of this decision will shape how generic companies respond to the forfeiture
provisions and underscore the need for generic companies to diligently pursue FDA approval of
their applications,” said Mr. Schultz.
Mr. Schultz was assisted in this representation by partner Alexandra W. Miller, counsel Andrew
N. Goldfarb and associate Lisa L. Barclay.
Founded in 1975, Zuckerman Spaeder has more than 105 attorneys and specializes in the areas of complex commercial and criminal litigation, and food and drug law. The firm is “AV” rated by Martindale-Hubbell and has offices in Washington, DC; New York; Tampa; Baltimore; and Wilmington, DE. In 2005, the firm was named a top five litigation boutique by The American Law
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