The launch follows a decision from the US District Court for the District of New Jersey that US Patent No. 7,524,834 is invalid, and AstraZeneca’s request for a permanent injunction is denied.
In August 2012, Actavis secured final approval from the US Food and Drug Administration (FDA) for the abbreviated new drug application (ANDA) for its generic version of Pulmicort Respules.
The drug is used to control and prevent asthma symptoms in children ages 12 months to eight years.
Total US brand and generic sales of Pulmicort Respules were about $1.1bn, for the 12 months ended 30 June 2014.
Actavis is focused in developing and manufacturing generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products and has commercial operations in about 60 countries.
The company also develops new medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women’s health, urology, cardiovascular, respiratory and anti-infective therapeutic categories.