DUBLIN, July 30, 2015 /PRNewswire/ -- Allergan plc
(NYSE: AGN) 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 Treprostinil Inhalation Solution,
0.6 mg/mL, 2.9 mL ampules. Allergan's ANDA product is a
generic version of United Therapeutics Corporation's Tyvaso®, which
is indicated for the treatment of pulmonary arterial hypertension
(PAH) to improve exercise ability.
Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO
United Therapeutics filed suit against Allergan on July 22, 2015 in the U.S. District Court for the
District of New Jersey seeking to
prevent Allergan from commercializing its ANDA product prior to the
expiration of certain U.S. Patents. The lawsuit was filed under the
provisions of the Hatch-Waxman Act, resulting in a stay of final
FDA approval of Allergan's ANDA for up to 30 months from the date
the plaintiffs received notice of Allergan's ANDA filing or until
final resolution of the matter before the court, whichever occurs
sooner, subject to any other exclusivities.
Based on available information, Allergan believes it may be a
"first applicant" to file an ANDA for the generic version of
Tyvaso® and, should its ANDA be approved, may be entitled to 180
days of generic market exclusivity.
For the 12 months ending December 31,
2014, Tyvaso® had U.S. sales of approximately $463 million, according to United
Therapeutics.
About Allergan
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a unique, global pharmaceutical company and a leader in a new
industry model – Growth Pharma. Allergan is focused on
developing, manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the
world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
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 longer, healthier
lives.
For more information, visit Allergan's website at
www.allergan.com
Forward-Looking Statement
Statements contained
in this press release 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 Quarterly Report on Form
10-Q for the quarter ended March 31,
2015 (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.
Tyvaso® is a registered trademark of United Therapeutics
Corporation.
CONTACTS:
|
|
|
Investors:
|
|
Lisa
DeFrancesco
|
|
(862)
261-7152
|
|
|
|
Media:
|
|
Mark
Marmur
|
|
(862)
261-7558
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/allergan-confirms-generic-tyvaso-patent-challenge-300120977.html
SOURCE Allergan plc