Forest Obtains Six Months U.S. Pediatric Exclusivity for NAMENDA® and NAMENDA XR®
June 18 2014 - 8:30AM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX) announced today that the
U.S Food and Drug Administration (FDA) has granted pediatric
exclusivity for memantine hydrochloride. Based on this decision, an
additional six months of U.S. market exclusivity will attach to the
patents that are listed in FDA’s Orange Book for NAMENDA and
NAMENDA XR.
As previously disclosed, under the terms of settlement
agreements, certain generic companies have licenses that will
permit these companies to launch their generic versions of NAMENDA
three months before the expiration of U.S. Patent No. 5,061,703,
including any extensions and/or pediatric exclusivities, or earlier
in certain circumstances. Accordingly, we would expect generic
entry sometime in July 2015.
About Forest Laboratories
Forest Laboratories (NYSE:FRX) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. Forest markets a portfolio of branded drug products
and develops new medicines to treat patients suffering from
diseases principally in five therapeutic areas: central nervous
system, cardiovascular, gastrointestinal, respiratory, and
anti-infective. Forest’s strategy of acquiring product rights for
development and commercialization through licensing, collaborative
partnerships and targeted mergers and acquisitions allows Forest to
take advantage of attractive late-stage development and commercial
opportunities, thereby managing the risks inherent in drug
development. In January 2014, Forest acquired Aptalis
Pharmaceuticals for $2.9 billion in cash in order to gain access to
its GI and Cystic Fibrosis products, including treatments for
Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures,
and Pancreatic Insufficiency. In February 2014, Forest and Actavis
plc announced an agreement where Forest would be acquired for about
$25 billion in cash and stock. The acquisition of Forest by Actavis
is contingent upon regulatory and shareholder approvals.
Forest is headquartered in New York, NY. To learn more, visit
www.frx.com.
Except for the historical information contained herein, this
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings. Forest assumes no obligation
to update forward-looking statements contained in this release to
reflect new information or future events or developments.
Media Relations:For Forest Laboratories, Inc.Amanda Kaufman,
646-231-7316amanda.kaufman@frx.comorInvestor Relations:Frank J.
Murdolo, 212-224-6714,media.relations@frx.com
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