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The Medicine Chest: The Non-Finality of Final ANDA Approvals

By Steven R. Ludwig, Ph.D.

IP Today Columnist Steven Ludwig is a U.S. patent attorney with the law firm of Venable LLP in Washington, D.C.  Dr. Ludwig’s legal practice includes litigating and prosecuting pharmaceutical / biotech cases for his clients.  He can be reached at 202-344-4690 or via email at

On September 17, 2007, in a win for AstraZeneca (and the branded pharmaceutical industry, in general), the U.S. District Court for the District of Columbia denied Apotex’s motion for injunctive relief in Apotex, Inc. v. Food and Drug Administration (FDA), Civil Action No. 07-1194 (D.D.C. 2007).1

In brief, Apotex sued the Food and Drug Administration (FDA) for converting the FDA’s final approval of its generic version of AstraZeneca’s Prilosec® to a tentative approval.   This conversion forced Apotex to immediately cease distribution of its generic drug. 

The procedural background of the case began on December 5, 2000 when Apotex filed an abbreviated new drug application (ANDA) for permission to market a generic version of Prilosec®.  Apotex’s ANDA included paragraph IV certifications that either AstraZeneca's patents were invalid or the product would not infringe the claims.  In response to this f...

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