Watson Pharmaceuticals said Sunovion Pharmaceuticals has challenged Watson Laboratories filing of Abbreviated New Drug Application(ANDA)with the US Food and Drug Administration(FDA)seeking approval for marketing Levalbuterol Tartrate Inhalation Aerosol,0.045 mg/actuation.
The Levalbuterol Tartrate Inhalation Aerosol,a generic version of Sunovion Pharmaceuticals'Xopenox HFA,is used to treat bronchospasm in adults,adolescents,4 years children and older with reversible obstructive airway disease.
On 27July 2012,Sunovion Pharmaceuticals lodged a suit against Watson in the Delaware district court of US to stop Watson from commercializing Sunovion ANDA product before the expiration of certain US patents.
Sunovion's lawsuit,which is based on the provisions of the Hatch-Waxman Act,has resulted in a stay of final?FDA?approval of Watson's ANDA for up to 30 months.
Watson,based on the available sources,believes it may be a first applicant to file an ANDA for the generic version of Xopenox HFA and if its ANDA gets approved,it may be entitled to 180 days of generic market exclusivity.
