Actavis Confirms Generic Suboxone® Sublingual Film Patent Challenge
DUBLIN, Oct. 8, 2013
DUBLIN, Oct. 8, 2013 /PRNewswire/ --Actavis plc (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 Buprenorphine
Hydrochloride and Naloxone Hydrochloride Sublingual Film 2 mg/0.5 mg and 8
mg/2 mg. Actavis' ANDA product is a generic version of Reckitt Benckiser's
Suboxone^® Sublingual Film, which is indicated for maintenance treatment of
Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited and
MonoSol Rx, LLC filed suit against Actavis on October 8, 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 certain of U.S.
patents. 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, including a submission date listed on FDA's
Paragraph IV Patent Certifications web site that is consistent with the date
of Actavis' ANDA filing, Actavis believes it may be a "first applicant" to
file an ANDA for a generic version of Suboxone^® Film and, should its ANDA be
approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending August 31, 2013, Suboxone^® Film 2/0.5mg and 8/2 mg
had total U.S. sales of approximately $1.2 billion, according to IMS Health
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 Pharma markets generic, branded generic, legacy brands and
Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty
Brands is a global branded specialty pharmaceutical business focused
principally in the Urology and Women's Health therapeutic categories, as well
as Gastroenterology and Dermatology. 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 distributor.
For press release and other company information, visit Actavis' Web site at
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, Inc.'s Annual
Report on Form 10-K for the year ended December 31, 2012 (as revised pursuant
to Actavis, Inc.'s Current Report on Form 8-K dated as of June 17, 2013, which
was filed with the SEC on June 18, 2013) and Quarterly Reports on Form 10-Q
for the periods ended March 31, 2013 and June 30, 2013, and Warner Chilcott's
periodic public filings with the Securities and Exchange Commission, including
but not limited to Warner Chilcott's Annual Report on Form 10-K for the year
ended December 31, 2012 and its Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2013 and June 30, 2013. Except as expressly required
by law, Actavis disclaims any intent or obligation to update these
Suboxone^® is a registered trademark of Reckitt Benckiser Healthcare (UK) Ltd.
SOURCE Actavis plc
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