(By Balachander) Perrigo Co. (NASDAQ:PRGO) said it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for the generic version of ProAir HFA inhalation aerosol.
ProAir HFA (albuterol sulfate) Inhalation Aerosol is a prescription medicine indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm symptoms.
Allegan, Michigan-based Perrigo had notified Teva Branded Pharmaceutical Products R&D, Inc., the owner of the New Drug Application, and others, of its ANDA filing that challenged the patents listed in FDA's Orange Book.
On Wednesday, Teva (NYSE:TEVA) filed suit against Perrigo and Catalent in the United States District Court for the District of Delaware, alleging patent infringement.
Perrigo said it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
The ANDA filing involved contributions from both Perrigo and Catalent Pharma Solutions, Inc., who partnered on the development of this project.
Annual sales of ProAir HFA were roughly $1.07 Billion annually, as measured by Wolters Kluwer Health.
Perrigo makes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals.
Shares of Perrigo gained 1.80 percent to trade at $112.32 on Thursday. Over the past year, the stock has been trading between $87.01 and $119.29.