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Press Release

Allergan Issues Statement on Namenda XR Patent Litigation Following Announcement of ANDA Approvals

Allergan
Posted on: 30 Sep 16

DUBLIN, Sept. 29, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), today issued the following statement regarding ongoing litigation on patents related to NAMENDA XR® (memantine hydrochloride) extended release capsules following announcement of FDA final ANDA approval by Lupin.

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"As announced on September 10, 2015, Allergan's Forest Laboratories subsidiaries and its licensors announced a settlement agreement regarding their Namenda XR ANDA litigation with Amneal Pharmaceuticals as first filer and granted a licensed entry date of January 31, 2020.  In addition, the Company has settled with all other Namenda XR ANDA defendants, including Lupin Limited and Lupin Pharmaceuticals, Inc., and the Company has not announced any earlier licensed entry dates. 

One of the licensed patent families covering Namenda XR has been held invalid by the Federal District Court for the District of Delaware.  That decision is under appeal to the U.S. Court of Appeals for the Federal Circuit. The Company will defend the validity of these patents on appeal and believes that its arguments on appeal are substantial and meritorious.

If the district court ruling on these patents is upheld, there is a possibility that generic entry for Namenda XR could occur following an adverse Court of Appeals decision." 

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Our Company's success is powered by our more than 15,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live healthier lives everyday.

For more information, visit Allergan's website at www.Allergan.com.

Forward-Looking Statement

Statements contained in this communication that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS: 

Investors

 

Lisa DeFrancesco

 

(862) 261-7152


 

 

Media:

 

Mark Marmur

 

(862) 261-7558

For more information:
www.allergan.com/news/news/thomson-reuters/allergan-issues-statement-on-namenda-xr-patent-lit

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 30/09/2016

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