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Actavis Reaches Settlement With Mallinckrodt Over Exalgo® 32 Mg Dosage Strength

PARSIPPANY, N.J, Feb. 14, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today announced that it has reached a settlement with Mallinckrodt Inc. on outstanding patent litigation related to Actavis' generic version of the 32 mg dosage strength of Mallinckrodt's Exalgo ® (Hydromorphone Hydrochloride Extended-Release) tablets.  

In January of 2012, Actavis and Mallinckrodt previously settled litigation involving the 8 mg, 12 mg and 16 mg dosage strengths of the product.  Mallinckrodt filed its current lawsuit on October 25, 2012 in the U.S. District Court for the District of New Jersey following Actavis' filing of an Amendment to an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its product in the 32 mg dosage strength.

Under terms of the settlement agreement, Mallinckrodt has granted Actavis a royalty-free license to U.S. patents relating to Exalgo to sell Actavis' 32 mg product starting on May 15, 2014. Other details of the settlement were not disclosed.

Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of the 32 mg dosage strength of Exalgo ® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

About Actavis

Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.  The Company has global and U.S. headquarters in Parsippany, New Jersey, USA, and international headquarters in Zug, Switzerland. 

Actavis is the world's third-largest generics prescription drug manufacturer. Operating as Actavis Pharma, the Company develops, manufactures and markets generic, branded generic, legacy brands and Over-the-Counter (OTC) products in more than 60 countries. The Company is ranked in the top 3 in 12 global markets, the top 5 in 16 global markets, and in the top 10 in 33 global markets.  Actavis Pharma also develops and out-licenses generic pharmaceutical products outside the U.S. through its Medis third-party business, the world's largest generic pharmaceutical out-licensing business. Medis has more than 300 customers globally, and offers a broad portfolio of more than 200 products. 

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