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Perrigo Company (PRGO) Confirms First to File Patent Challenge For Generic Version of ProAir® HFA Inhalation Aerosol


9/6/2012 11:54:07 AM

ALLEGAN, Mich., Sept. 6, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO; TASE) announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) 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.

(Logo: http://photos.prnewswire.com/prnh/20120301/DE62255LOGO)

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 September 5, 2012, 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, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, dietary supplements and active pharmaceutical ingredients (API). 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. Visit Perrigo on the Internet (http://www.perrigo.com).

Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 30, 2012, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE Perrigo Company


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