Perrigo seeks approval for generic bronchospasm drug
ALLEGAN, Mich. — Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.
The generic drug maker said it had filed with the Food and Drug Administration for albuterol sulfate HFA inhalation aerosol, a generic version of Teva's ProAir HFA. Because Perrigo's approval application contained a legal challenge to Teva's patent, Teva filed suit against Perrigo and Catalent Pharma Solutions, which also contributed to the application, in the U.S. District Court for the District of Delaware Wednesday, alleging patent infringement.
While Teva's suit puts a stay on FDA approval of Perrigo's application, Perrigo likely will be entitled to 180 days of market exclusivity in which to compete directly against the branded product, as long as it wins approval from the agency.
ProAir, used to treat and prevent bronchospasm symptoms in children ages 4 years and older, has sales of about $1.07 billion, according to Wolters Kluwer Health.