Actavis Announces Daytrana® Patent Challenge Settlement

           Actavis Announces Daytrana® Patent Challenge Settlement

PR Newswire

DUBLIN, March 19, 2014

DUBLIN, March 19, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced
that it has entered into an agreement with Noven Pharmaceuticals, Inc. to
settle all outstanding patent litigation related to Actavis' generic version
of Daytrana^® (Methylphenidate Transdermal System). Daytrana^® is a CNS
stimulant indicated for the treatment of Attention Deficit Hyperactivity
Disorder.

Under the terms of the agreement, Noven will grant Actavis a non-exclusive,
royalty-bearing license to market its generic Daytrana^® beginning on Sept. 1,
2015, or earlier under certain circumstances. Other details of the settlement
were not disclosed.

Launch of Actavis' product is contingent upon Actavis receiving final approval
from the U.S. Food and Drug Administration on its Abbreviated New Drug
Application (ANDA) for generic Daytrana^®. Based on available information,
Actavis believes it may be a "first applicant" to file an ANDA for the generic
version of Daytrana^® and, should its ANDA be approved, may be entitled to 180
days of generic market exclusivity.

For the 12 months ending December 31, 2013, Daytrana^® had total U.S. sales of
approximately $98 million, according to IMS Health data.

About Actavis
Actavis plc (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 Dublin, Ireland
and U.S. administrative headquarters in Parsippany, New Jersey, USA.

Actavis develops and manufactures generic, brand, branded generic, legacy
brands and Over-the-Counter (OTC) pharmaceutical products and has commercial
operations in approximately 60 countries. The Company's North American
branded pharmaceuticals business is focused principally in the Women's Health,
Urology, Gastroenterology and Dermatology therapeutic categories with a strong
pipeline of products in various stages of development. Actavis 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 distributor.

For press release and other company information, visit Actavis' Web site at
http://www.actavis.com.

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 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; risks that resolution of patent infringement litigation through
settlement could result in investigations or actions by private parties or
government authorities or agencies; 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, including Medicare and
Medicaid, affecting among other things, pricing and reimbursement of
pharmaceutical products; and such other risks and uncertainties detailed in
Actavis' periodic public filings with the Securities and Exchange Commission,
including but not limited to Actavis plc's Annual Report on Form 10-K for the
year ended December 31, 2013. Except as expressly required by law, Actavis
disclaims any intent or obligation to update these forward-looking statements.

Daytrana^® is a registered trademark of Noven Therapeutics, LLC.

CONTACTS: Investors:
          Lisa DeFrancesco
          (862) 261-7152
          Media:
          Charlie Mayr
          (862) 261-8030
          David Belian
          (862) 261-8141



Actavis plc logo

Logo- http://photos.prnewswire.com/prnh/20130124/NY47381LOGO

SOURCE Actavis plc

Website: http://www.actavis.com
 
Press spacebar to pause and continue. Press esc to stop.