Legal Opinion

Mylan Pharmaceuticals Inc. v. United States Food & Drug Administration

District Court, District of Columbia

Decided May 2, 2011No. Civil Action 11-566 (JEB)PublishedCited by 9 opinions

1Opinion of the Court

MEMORANDUM OPINION *

JAMES E. BOASBERG, District Judge.

The Food and Drug Administration is currently reviewing the application of Ranbaxy Laboratories to have temporary exclusive rights to market a generic drug. Matrix Laboratories, a competitor that has a subsequent application pending for the same drug, eagerly wishes to know the result of Ranbaxy’s application. In fact, Matrix and its distributor Mylan Pharmaceuticals have now brought this injunctive action to force the FDA to act on Ranbaxy’s application. Because the interrelated concepts of standing and ripeness preclude such expansive…

2Cases cited28 opinions

  1. Lujan v. Defenders of WildlifeSupreme Court of the United States · 1992
  2. Scheuer v. RhodesSupreme Court of the United States · 1974
  3. Papasan v. AllainSupreme Court of the United States · 1986
  4. Allen v. WrightSupreme Court of the United States · 1984
  5. Heckler v. ChaneySupreme Court of the United States · 1985

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3Cited by9 opinions

  1. Astrazeneca Pharmaceuticals Lp v. Food and Drug AdministrationDistrict Court, District of Columbia · 2012
  2. Teva Pharm. United States, Inc. v. AzarCourt of Appeals for the D.C. Circuit · 2019
  3. Gerber Products Company v. VilsackDistrict Court, District of Columbia · 2017
  4. (PS)Fitten v. WhitleyDistrict Court, E.D. California · 2021
  5. American Oversight v. U.S. Department of Veterans AffairsDistrict Court, District of Columbia · 2020

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