Actavis Reaches Settlement with Mallinckrodt Over Exalgo 32 mg Dosage Strength

Thu Feb 14, 2013 9:00am EST

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PARSIPPANY, N.J,  Feb. 14, 2013  /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today
announced that it has reached a settlement with Mallinckrodt Inc. on outstanding
patent litigation related to Actavis' generic version of the 32 mg dosage
strength of  Mallinckrodt's Exalgo®  (Hydromorphone Hydrochloride
Extended-Release) tablets.  

In January of 2012, Actavis and  Mallinckrodt  previously settled litigation
involving the 8 mg, 12 mg and 16 mg dosage strengths of the product.  
Mallinckrodt  filed its current lawsuit on  October 25, 2012  in the U.S.
District Court for the District of  New Jersey  following Actavis' filing of an
Amendment to an Abbreviated New Drug Application (ANDA) with the U.S. Food and
Drug Administration (FDA) seeking approval to market its product in the 32 mg
dosage strength.

Under terms of the settlement agreement,  Mallinckrodt  has granted Actavis a
royalty-free license to U.S. patents relating to Exalgo to sell Actavis' 32 mg
product starting on  May 15, 2014. Other details of the settlement were not
disclosed.

Based on available information, Actavis believes it may be a "first applicant"
to file an ANDA for the generic version of the 32 mg dosage strength of Exalgo® 
and, should its ANDA be approved, may be entitled to 180 days of generic market
exclusivity.

About Actavis

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

Actavis is the world's third-largest generics prescription drug manufacturer.
Operating as Actavis Pharma, the Company develops, manufactures and markets
generic, branded generic, legacy brands and Over-the-Counter (OTC) products in
more than 60 countries. The Company is ranked in the top 3 in 12 global markets,
the top 5 in 16 global markets, and in the top 10 in 33 global markets.  Actavis
Pharma also develops and out-licenses generic pharmaceutical products outside
the U.S. through its Medis third-party business, the world's largest generic
pharmaceutical out-licensing business. Medis has more than 300 customers
globally, and offers a broad portfolio of more than 200 products.   

Actavis Specialty Brands is the Company's global branded specialty
pharmaceutical business, which develops and markets a portfolio of approximately
40 products principally in  the United States  and  Canada  that are focused in
the Urology and Women's Health therapeutic categories.  Actavis Specialty Brands
is committed to developing and marketing biosimilars products in Women's Health,
Oncology and other therapeutic categories, and currently has a portfolio of 5
biosimilar products in development.  

Actavis Global Operations has more than 30 manufacturing and distribution
facilities around the world, with a capacity of approximately 44 billion units
annually.  Actavis Global Operations also includes Anda, Inc., the
fourth-largest U.S. generic pharmaceutical product distributor in  the United
States.

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 impact of competitive
products and pricing; the timing and success of product launches; difficulties
predicting the timing our outcome of product development efforts and regulatory
agency approvals or actions, if any; 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' Annual Report on form 10-K for the year
ended  December 31, 2011  and its Quarterly Report on Form 10-Q for the period
ended  September 30, 2012  (such periodic public filings having been filed under
the "Watson Pharmaceuticals, Inc." name).  Except as expressly required by law,
Actavis disclaims any intent or obligation to update these forward-looking
statements.  

Exalgo®  is a registered trademark of Mallinckrodt LLC.

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

(Logo:  http://photos.prnewswire.com/prnh/20130124/NY47381LOGO)  

SOURCE  Actavis, Inc.

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