Perrigo Confirms First To File Patent Challenge For Generic Version Of ProAir® HFA Inhalation Aerosol

Perrigo Confirms First To File Patent Challenge For Generic Version Of ProAir®
                            HFA Inhalation Aerosol

PR Newswire

ALLEGAN, Mich., Sept. 6, 2012

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

Website: http://www.perrigo.com
Contact: Arthur J. Shannon, Vice President, Investor Relations and
Communication, +1-269-686-1709, ajshannon@perrigo.com, Bradley Joseph, Senior
Manager, Investor Relations and Communication, +1-269-686-3373,
bradley.joseph@perrigo.com