(By Balaseshan) Watson Pharmaceuticals Inc. (NYSE:WPI) said it has launched the generic version of Xopenex (levalbuterol HCl) Inhalation Solution as part of an agreement with Sunovion Pharmaceuticals Inc.
Watson began shipping the product Monday. Xopenex Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
Xopenex had total U.S. sales of about $474 million for the most recent twelve months ending June 30, 2012, according to IMS Health data.
Bronchospasm or a bronchial spasm is an excessive and prolonged contraction of the smooth muscle of the bronchi and bronchioles, resulting in an acute narrowing and obstruction of the respiratory airway.
The contractions may be localized or general and may be caused by irritation or injury to the respiratory mucosa, infections, or allergies. A cough with generalized wheezing usually indicates the condition. Bronchospasm is a chief characteristic of asthma.
Recently on August 15, Watson filed suit against the U.S. Food and Drug Administration (FDA) challenging the Agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of diabetes drug Actos (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets).
As a result of FDA's decision, Watson's abbreviated new drug application (ANDA) could be delayed for up to six months. Watson noted that it filed suit after communications with FDA regarding its ANDA failed to resolve the dispute and permit a timely launch.
Watson noted that in the event FDA fails to timely approve its ANDA for generic Actos, it remains confident that it can achieve its most recently disclosed forecast for full year 2012 due to a recent favorable update from the FDA related to another product and improved market conditions for certain products within the U.S. generics business.
WPI is trading down 0.73% at $79.32 on Monday. The stock has been trading between $55 and $81 for the past 52 weeks.