Actavis Confirms Generic Safyral® Patent Challenge

              Actavis Confirms Generic Safyral® Patent Challenge

PR Newswire

PARSIPPANY, N.J., June 5, 2013

PARSIPPANY, N.J., June 5, 2013 /PRNewswire/ --Actavis, Inc. (NYSE: ACT) today
confirmed that it has filed an Abbreviated New Drug Application (ANDA) with
the U.S. Food and Drug Administration (FDA) seeking approval to market
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets And Levomefolate
Calcium Tablets. Actavis' ANDA product is a generic version of Bayer's
Safyral^®, which is approved to prevent pregnancy in women who elect to use an
oral contraceptive, and to provide a daily dose of folate supplementation.

Merck & CIE, Bayer Pharma AG and Bayer Healthcare Pharmaceuticals Inc. filed
suit against Actavis on June 4, 2013, in the U.S. District Court for the
District of Delaware seeking to prevent Actavis from commercializing its ANDA
product prior to the expiration of U.S. patent no. 6441168 (the '168 patent).
The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting
in a stay of finalFDAapproval of Actavis' ANDA for up to 30 months from the
date the plaintiffs received notice of Actavis' ANDA filing or until final
resolution of the matter before the court, whichever occurs sooner, subject to
any other exclusivities.

Based on available information, Actavis believes it may be a "first applicant"
to file an ANDA for the generic version of Safyral^® and, should its ANDA be
approved, may be entitled to 180 days of generic market exclusivity.

For the 12 months ending April 30, 2013, Safyral^® had total U.S. sales of
approximately $19 million according to IMS Health data.

About Actavis

Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical
company focused on developing, manufacturing and distributing generic, brand
and biosimilar products. Actavis has global headquarters in Parsippany, New
Jersey, USA.

Operating as Actavis Pharma, Actavis develops, manufactures and markets
generic, branded generic, legacy brands and Over-the-Counter (OTC) products in
more than 60 countries. Actavis Specialty Brands is Actavis' global branded
specialty pharmaceutical business focused in the Urology and Women's Health
therapeutic categories. Actavis Specialty Brands also has a portfolio of five
biosimilar products in development in Women's Health and Oncology. Actavis
Global Operations has more than 30 manufacturing and distribution facilities
around the world, and includes Anda, Inc., a U.S. pharmaceutical product

For press release and other company information, visit Actavis' Web site at

Forward-Looking Statement

Statements contained in this press release that refer to non-historical facts
are forward-looking statements that reflect Actavis' current perspective of
existing information as of the date of this release. It is important to note
that Actavis' goals and expectations are not predictions of actual
performance. Actual results may differ materially from Actavis' current
expectations depending upon a number of factors, risks and uncertainties
affecting Actavis' business. These factors include, among others; the
difficulty of predicting the timing and outcome of the pending patent
litigation; the difficulty of predicting the timing or outcome of product
development efforts, including FDA and other regulatory agency approvals and
actions, if any; the impact of competitive products and pricing; the timing
and success of product launches; difficulties or delays in manufacturing; the
availability and pricing of third party sourced products and materials;
successful compliance with FDA and other governmental regulations applicable
to Actavis and its third party manufacturers' facilities, products and/or
businesses; changes in the laws and regulations; and such other risks and
uncertainties detailed in Actavis' periodic public filings with the Securities
and Exchange Commission, including but not limited to Actavis' Quarterly
Report on Form 10-Q for the quarter ended March 31, 2013 and Actavis' Annual
Report on form 10-K for the year ended December 31, 2012. Except as expressly
required by law, Actavis disclaims any intent or obligation to update these
forward-looking statements.

Safyral^® is a registered trademark of Bayer.


Lisa DeFrancesco
(862) 261-7152
Charlie Mayr
(862) 261-8030

(Logo: )

SOURCE Actavis, Inc.

Press spacebar to pause and continue. Press esc to stop.