PUREPAC PHARMACEUTICAL CO. v. FRIEDMAN

Nos. 98-5334, 98-5335 and 98-5337.

162 F.3d 1201 (1998)

PUREPAC PHARMACEUTICAL COMPANY, Appellant, v. Michael A. FRIEDMAN, M.D., Acting Commissioner of Food and Drugs, Food and Drug Administration, Appellee.

United States Court of Appeals, District of Columbia Circuit.

Decided December 29, 1998.


Attorney(s) appearing for the Case

Robert A. Dormer argued the cause for appellants. With him on the joint briefs were James R. Phelps, Douglas B. Farquhar, David M. Malone, John F. Cooney, John R. Fleder, David F. Weeda and Arthur Y. Tsien. Brett T. Schwemer entered an appearance.

Howard S. Scher, Attorney, U.S. Department of Justice, argued the cause for the federal appellee. On the brief were Frank W. Hunger, Assistant Attorney General, Wilma A. Lewis, U.S. Attorney, Douglas N. Letter, Appellate Litigation Counsel, U.S. Department of Justice, and Jeffrica Jenkins Lee, Attorney.

James D. Miller argued the cause for intervenors-appellees Torpharm, A Division of Apotex, Inc., et al. With him on the joint brief were Eugene M. Pfeifer and Donald O. Beers.

Before: RANDOLPH, ROGERS, and TATEL, Circuit Judges.


Opinion for the Court filed by Circuit Judge RANDOLPH.

RANDOLPH, Circuit Judge:

"The active ingredients in most prescription drugs constitute less than 10% of the product; inactive `excipients' (such as coatings, binders, and capsules) constitute the rest. The term `generic drug' is used to describe a product that contains the same active ingredients but not necessarily the same excipients as a so-called `pioneer drug' that is marketed under a brand name....

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