AMRI has filed two new patent infringement lawsuits in U.S. District Court in New Jersey against Dr. Reddy’s Laboratories, Ltd., Dr. Reddy’s Laboratories, Inc. and Sandoz, Inc. (“the defendants”) for infringement of AMRI’s U.S. Patent Number 7,390,906. The recently issued patent relates to the manufacturing process for the active ingredient in sanofi-aventis’s Allegra® and Allegra®D drug products.
This legal action relates to generic versions of sanofi-aventis’s Allegra® and Allegra®D drug products for which the defendants are seeking or have obtained marketing approval from the U.S. Food and Drug Administration (“FDA”) and which the defendants have marketed in the United States.
“We believe that this patent infringement filing strengthens our litigation strategy on Allegra®, Allegra®D-12, and Allegra®D-24 against these generic drug companies in the United States and other jurisdictions. AMRI remains committed to vigorously protecting and enforcing its intellectual property,” said AMRI Chairman, President and CEO Thomas E. D'Ambra.
In November 2008, AMRI announced a settlement regarding two U.S. patent infringement litigations involving Allegra® and Allegra®D-12 to allow sanofi-aventis U.S. LLC to sublicense patents related to Allegra® and Allegra®D-12 to Teva Pharmaceuticals, USA, Inc. and Barr Laboratories, Inc. in the United States for which AMRI receives royalties on the sale of products containing fexofenadine hydrochloride (the generic name for the active ingredient in Allegra® ) and products containing fexofenadine hydrochloride and pseudoephedrine hydrochloride (generic Allegra®D-12) by Teva Pharmaceuticals, USA, Inc. and Barr Laboratories, Inc. through 2015, along with additional considerations.