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HI-TECH PHARMACAL CO. v. U.S. FOOD AND DRUG ADMIN.

Civil Action No. 08-01495 (JDB).

587 F.Supp.2d 13 (2008)

HI-TECH PHARMACAL CO., INC., Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendant, and Apotex, Inc., Intervenor-Defendant.

United States District Court, District of Columbia.

December 10, 2008.

Attorney(s) appearing for the Case

James Philip Ellison, Hyman, Phelps & McNamara, P.C., Washington, DC, Alfred Benjamin Engelberg, Alfred Benjamin Engelberg, Esq., Palm Beach, FL, for Plaintiff.

Drake S. Cutini, Steven Y. Bressler, Department of Justice, Office of Consumer Litigation, Washington, DC, for Defendant.

Carmen Mercedes Shepard, Kate Cumming Beardsley, Madhusha Dissanayake, Buc & Beardsley, Michael D. Shumsky, Kirkland & Ellis, LLP, Washington, DC, for Intervenor-Defendant.

MEMORANDUM OPINION

JOHN D. BATES, District Judge.

On October 28, 2008, defendant Food and Drug Administration ("FDA") issued a final letter decision in which it determined that plaintiff Hi-Tech Pharmacal Co., Inc. ("Hi-Tech") had forfeited its 180-day period of marketing exclusivity under the Federal Food, Drug, and Cosmetic Act for the generic version of the branded drug CSOPT. Currently before the Court is Hi-Tech's motion for a preliminary injunction...

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