Actavis, Inc. (NYSE: ACT) today confirmed that the United States District Court for the District of New Jersey has ruled that Actavis’ generic version of AstraZeneca’s Pulmicort RESPULES® (budesonide inhalation suspension) 0.25, 0.5 mg, and 1 mg vials do not infringe United States Patent No. 7,524,834 (the ‘834 Patent) and that United States Patent No. 6,598,603 (the ‘603 Patent) is invalid. Actavis intends to launch the 0.25 and 0.5 mg products immediately.
Actavis’ Abbreviated New Drug Application (“ANDA”) for its generic version of Pulmicort RESPULES® in the 0.25 and 0.5 mg strengths received final approval from the U.S. Food and Drug Administration in August 2012. Actavis’ ANDA for the 1 mg strength is still pending.
Pulmicort RESPULES® is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years. For the 12 months ended January 31, 2013, total U.S. brand and generic sales of Pulmicort RESPULES® were approximately $1.2 billion.
Actavis will provide an update of its 2013 forecast on its Q1 2013 earnings conference call, which it expects to hold on May 2, 2013.
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.
Actavis Specialty Brands is the Company’s global branded specialty pharmaceutical business, which develops and markets a portfolio of approximately 40 products principally in the United States and Canada that are focused in the Urology and Women’s Health therapeutic categories. Actavis Specialty Brands is committed to developing and marketing biosimilars products in Women’s Health, Oncology and other therapeutic categories, and currently has a portfolio of 5 biosimilar products in development.
Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, with a capacity of approximately 44 billion units annually. Actavis Global Operations also includes Anda, Inc., the fourth-largest U.S. generic pharmaceutical product distributor in the United States.
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