Barr Pharma (now part of Teva) announced (in a press release here) that it has entered into separate settlement agreements related to ongoing patent challenges for Nasacort (Triamcinolone acetonide) nasal spray, Allegra(R) D-12 Hour (Fexofenadine hydrochloride 60mg and Pseudoephedrine hydrochloride 120mg) extended-release tablets, and Allegra(R) (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(R) AQ years prior to the expiration of the applicable patents, and the launch of a generic version of Allegra(R) D-12 in November of 2009," said Bruce L. Downey, Barr's Chairman and CEO. "The agreement related to Allegra(R) resolves any ongoing uncertainty about the possible impact of ongoing litigation for Barr and Teva related to the launch of generic versions of Allegra(R) 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 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(R) AQ. Under this agreement, Barr will have a license to launch a generic version of Nasacort(R) 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(R) 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 (NASDAQ: PRGO; TASE) and, under the terms of a separate agreement, will share in the costs and potential benefits with Perrigo.
Allegra(R) 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(R) 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(R) 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(R) 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(R) (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.
Earlier, on September 6, 2005, Barr announced that it was working with Teva and has launched this product as a generic "at risk." Sanofi-Aventis countered a week or so later with an authorized generic arrangement with Prasco and is also making attempts to enjoin Barr and speed up the trial process. Barr and Sanofi Aventis were in litigation on polymorph, formulation and method of use patents of Fexofenadine.
Link to related news Here
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