Legal Opinion

Astrazeneca Pharmaceuticals Lp v. Food and Drug Administration

District Court, District of Columbia

Decided March 23, 2012No. Civil Action No. 2012-0388PublishedCited by 10 opinions

1Opinion of the Court

MEMORANDUM OPINION

COLLEEN KOLLAR-KOTELLY, District Judge.

Plaintiff AstraZeneca Pharmaceuticals LP (“AstraZeneca”) holds new drug applications for SEROQUEL® (“Seroquel”) and SEROQUEL XR® (“Seroquel XR”), antipsychotic drugs used te treat serious psychological disorders such as schizophrenia. Since AstraZeneca first obtained approval to market these drugs-in the United States from the Food and 1feg Administration (the “FDA”), it hassrcen free to market them without “gengW” competition. Next week, on MondSfMarch 26, 2012, one of AstraZeneql® exclusivity rights, a so-called “pediatiHIxclusivity”…

2Cases cited25 opinions

  1. Winter v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 2008
  2. Abbott Laboratories v. GardnerSupreme Court of the United States · 1967
  3. Califano v. SandersSupreme Court of the United States · 1977
  4. Duke Power Co. v. Carolina Environmental Study Group, Inc.Supreme Court of the United States · 1978
  5. Texas v. United StatesSupreme Court of the United States · 1998

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3Cited by10 opinions

  1. AstraZeneca Pharmaceuticals LP v. Food & Drug AdministrationCourt of Appeals for the D.C. Circuit · 2013
  2. Viropharma Incorporated v. HamburgDistrict Court, District of Columbia · 2012
  3. Astrazeneca Pharmaceuticals Lp v. Food and Drug AdministrationDistrict Court, District of Columbia · 2012
  4. Veloxis Pharmaceuticals, Inc. v. United States Food and Drug AdministrationDistrict Court, District of Columbia · 2015
  5. Investment Company Institute v. United States Commodity Futures Trading CommissionDistrict Court, District of Columbia · 2012

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