Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced that it has reached a settlement with Perrigo Pharmaceutical Co. and Catalent Pharma Solutions LLC with respect to four patents for Teva’s ProAir
HFA (albuterol sulfate) Inhalation Aerosol product. This settlement provides a license to Perrigo and Catalent to sell limited units of Perrigo’s generic version of the product for an initial period beginning Dec. 19, 2016 and lasting until June 2018, when the limits will no longer apply.
This settlement dismisses pending litigation in the U.S. District Court for the District of Delaware in which Teva filed suit against Perrigo and Catalent in response to a notice of the filing of an ANDA containing a paragraph (IV) certification directed against four (4) of the five (5) patents listed in the Orange Book for ProAir
HFA (U.S. Patent 7,105,152, which expires September 12, 2023; 7,566,445, which expires June 4, 2017; 6,446,627, which expires December 18, 2017; and 8,132,712, which expires September 7, 2028.) Additional terms of the settlement are agreed by the parties to remain undisclosed.
There are currently no additional challenges to the IP for ProAir
HFA and no further litigation pending. Teva will continue to vigorously defend its intellectual property rights relating to its products.
HFA is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.