Perrigo Confirms First To File Patent Challenge For Generic Version Of ProAir

ALLEGAN -- Allegan-based Perrigo Co. (Nasdaq: PRGO) announced that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for albuterol sulfate HFA inhalation aerosol, the generic version of ProAir HFA.

The ANDA filing involved contributions from both Perrigo and Catalent Pharma Solutions Inc., who partnered on the development of this project.

Perrigo previously 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 Sept. 5, Teva filed suit against Perrigo and Catalent in the United States District Court for the District of Delaware, alleging patent infringement. This action formally initiates the litigation process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.

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. Annual sales were approximately $1.07 Billion annually, as measured by Wolters Kluwer Health.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our long-term investment in extended topical (respiratory) product development. We are pleased to be partnering with Catalent on this important new product opportunity. As always, Perrigo is committed to making quality healthcare more affordable for our customers."

From its beginnings as a packager of generic home remedies in 1887, Allegan-based Perrigo has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, dietary supplements and active pharmaceutical ingredients. The company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The company's primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia.

More at www.perrigo.com.