Perrigo (PRGO) Settles Nasacort(R) Patent Litigation

November 19, 2008 8:25 AM EST

Perrigo Company (Nasdaq: PRGO) today acknowledges the settlement of patent litigation brought by Sanofi-Aventis (NYSE: SNY) against Barr Laboratories, Inc. a subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL). The suit was brought in the U.S. District Court of Delaware 2006 based upon Barr's filing of an ANDA for Triamcinolone Acetonide Nasal Spray containing a paragraph IV certification. Barr believes that it is the first to file an Abbreviated New Drug Application containing a paragraph IV certification for NASACORT AQ. Barr developed its Triamcinolone Acetonide Nasal Spray product with Perrigo Company and the ANDA is awaiting final approval from FDA.

Under the terms of the settlement, Barr will be able to market the ANDA product under license from Sanofi-Aventis as early as June 15, 2011 if Barr's ANDA is approved by that date, or earlier in certain circumstances. In addition, even if 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. Perrigo will share in the costs and benefits of the settlement agreement between Barr and Sanofi-Aventis and in Barr's marketing of the products under the agreement.

Perrigo Company, through its subsidiaries, develops, manufactures, and distributes over-the-counter (OTC) and prescription (Rx) pharmaceuticals, nutritional products, active pharmaceutical ingredients (API), and consumer products worldwide.


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