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pharmiweb.com today | 20 November 2008
Sanofi-aventis Announces the Settlement of Nasacort® AQ U.S. Patent Litigation and Certain Allegra®/Allegra® D-12 U.S. Patent Litigations
Paris, France - November 19, 2008 - Sanofi-aventis announced today the signature of agreements
to settle the U.S. patent infringement suits related to Barr Pharmaceuticals and Teva
Pharmaceuticals’ generic version of Allegra® (fexofenadine hydrochloride), as well as the U.S.
patent infringement suits related to Barr’s proposed generic versions of Allegra® D-12 Hour
(fexofenadine hydrochloride; pseudoephedrine hydrochloride) (Allegra® D-12) and Nasacort®
(triamcinolone acetonide) AQ. In each case, the settlement agreement is subject to review by the
Federal Trade Commission and U.S. state Attorneys General.
Under the terms of the agreements, in exchange for payment of royalties, sanofi-aventis US has
agreed to grant Barr and Teva a license to certain patent rights to permit Barr and Teva to sell
generic versions of Allegra® 30-mg, 60-mg, and 180-mg tablets in the United States, and to grant
Barr a license to certain patent rights to sell generic versions of Allegra® D-12 and Nasacort® AQ in
the United States at a future date. In each case, the license is to be non-exclusive, will allow
generic entry prior to the expiration of sanofi-aventis US’ patents, and will not preclude sanofiaventis
US’ own marketing of a generic version of these products. No license is granted with
respect to any other Allegra® product.
With respect to Allegra®, for which Barr and Teva already market a U.S. generic, royalties are to be
retroactively applied to past sales. Royalty rates under the Allegra® D-12 and the Nasacort® AQ
licenses will take into account the number of AB-rated generics of these products on the U.S.
market.
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