Barr announces agreements on Nasacort AQ, Allegra D-12 and Allegra patent challenges

Published on November 19, 2008 at 10:03 PM · No Comments

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has entered into separate settlement agreements related to ongoing patent challenges for Nasacort AQ (triamcinolone acetonide) nasal spray, Allegra D-12 Hour (fexofenadine hydrochloride 60mg and pseudoephedrine hydrochloride 120mg) extended-release tablets, and Allegra (fexofenadine) 30mg, 60mg and 180mg tablets.

As part of the settlements, the parties have agreed to dismiss the underlying U.S. litigation related to the three patent challenge cases.

"We are very pleased to have reached these three separate settlements, bringing to a close the outstanding patent challenges in a manner that results in the date certain launch of a generic version of Nasacort AQ years prior to the expiration of the applicable patents, and the launch of a generic version of Allegra D-12 in November of 2009," said Bruce L. Downey, Barr's Chairman and CEO. "The agreement related to Allegra resolves any ongoing uncertainty about the possible impact of ongoing litigation for Barr and Teva related to the launch of generic versions of Allegra 30mg, 60mg and 180mg tablets in September 2005. We believe that these agreements represent a pro-consumer resolution to this ongoing litigation."

The individual agreements are subject to review by the Federal Trade Commission (FTC) and state Attorneys General under an outstanding consent decree and settlement entered into by a Sanofi-Aventis predecessor company, and will not become effective for approximately 45 days. The parties may prevent the agreements from becoming effective or terminate the agreements if the FTC or state attorney generals raise objections that cannot be resolved by the parties.

Nasacort AQ Settlement and License Agreement

Barr Laboratories, Inc. has signed a Settlement and License Agreement with Sanofi-Aventis US LLC and Aventis Pharmaceuticals Inc. to resolve the patent litigation involving Barr's Triamcinolone Acetonide nasal spray, the generic versions of Aventis Pharmaceuticals' Nasacort AQ. Under this agreement, Barr will have a license to launch a generic version of Nasacort AQ as early as June 15, 2011 if Barr's ANDA is approved on that date, or earlier in certain circumstances. In addition, even if the Barr's ANDA is not approved, Barr will have a license to launch a generic version of Nasacort AQ, supplied by Sanofi-Aventis, on December 1, 2013, or earlier, in certain circumstances. Upon product launch, Barr would pay Sanofi-Aventis a royalty.

Barr developed its Triamcinolone Acetonide Nasal Spray product with Perrigo Company and, under the terms of a separate agreement, will share in the costs and potential benefits with Perrigo.

Allegra D-12 Settlement and License Agreement

Barr Laboratories, Inc. has signed a Settlement and License Agreement with Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. to settle the outstanding patent litigation involving Barr's generic version of Aventis Pharmaceuticals' Allegra D-12 Hour (fexofenadine hydrochloride 60mg and pseudoephedrine hydrochloride 120mg) extended-release tablets. Under the terms of this agreement, Barr is permitted to launch a generic version of Aventis Pharmaceuticals' Allegra D-12 extended-release tablets on November 1, 2009, and Barr has the right to acquire product from Sanofi-Aventis for commercial launch. Upon product launch, Barr would pay Sanofi-Aventis a royalty.

Allegra Tablets Settlement Agreement

Barr Laboratories, Inc. and Teva Pharmaceuticals USA, Inc. have signed an agreement with Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. to settle the outstanding patent litigation involving Barr's and Teva's generic version of Aventis Pharmaceuticals' Allegra (fexofenadine) 30mg, 60mg and 180mg tablets, which Teva launched in September 2005 under a separate agreement with Barr. Under the terms of this agreement, Barr and Teva will each pay Aventis approximately $30 million to settle the patent litigation with Aventis regarding Teva's fexofenadine 30mg, 60mg and 180mg tablets product. In addition, Barr and Teva will pay Aventis a royalty on future U.S. sales.

Posted in: Medical Patent News

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