Par Pharmaceutical Companies Inc. and Dr. Reddy’s Laboratories have released generic versions of AstraZeneca's Accolate asthma drug in the United States.


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Generic versions of Accolate ship

November 23rd, 2010

NEW YORK – Par Pharmaceutical Companies Inc. and Dr. Reddy’s Laboratories have released generic versions of AstraZeneca's Accolate asthma drug in the United States.

Par said Monday that it has entered into an exclusive U.S. supply and distribution agreement with AstraZeneca to distribute the authorized generic version of Accolate (zafirlukast). Par has begun shipping 10-mg and 20-mg strengths of zafirlukast tablets.

Citing IMS Health data, Par reported that annual U.S. sales for Accolate are approximately $50 million. Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.

A couple of days earlier, India-based Dr. Reddy's announced that it has launched zafirlukast tablets in the U.S. market.

The company said that on Nov. 15 the U.S. District Court of New Jersey granted it motion for summary judgment of noninfringement against AstraZeneca, clearing the way for the launch of the product. Subsequently, the Food and Drug Administration approved Dr. Reddy's abbreviated new drug application (ANDA) for zafirlukast tablets.

Dr. Reddy's said its zafirlukast tablets are available in 60-count bottles in 10-mg and 20-mg dosage strengths.

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