The FDA has approved Watson Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for a generic version of Pulmicort Respules. The budesonide inhalation suspension 0.25mg/2mL and 0.5mg/2mL ampules are the subject of an ongoing patent dispute with AstraZeneca. Watson says that it if it prevails in court, it will launch the budesonide product by the end of this year.
The company has also been sued by Sunovion, Watson said, after submitting an ANDA for a levalbuterol tartrate metered dose inhaler, a generic version of Sunovion’s Xopenex HFA MDI. Watson says that it believes that it is the first applicant to file an ANDA for a generic equivalent of Xopenex and would therefore get 180 days of generic market exclusivity if the application is approved. The lawsuit will result in a stay of approval for as long as 30 months.
Read Watson press release on generic budesonide approval.
Read Watson press release on Xopenex suit.
