Impax Laboratories Confirms Patent Challenge Relating to OXYCONTIN® 10, 15, 20, 30, 40, 60, and 80 mg
April 11 2011 - 9:00AM
Business Wire
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms
that it has initiated a challenge of the patents listed by Purdue
Pharma L.P. in connection with Oxycontin® (Oxycodone hydrochloride)
10, 15, 20, 30, 40, 60, and 80 mg controlled-release tablets.
Impax filed its Abbreviated New Drug Application (ANDA)
containing a paragraph IV certification for a generic version of
Oxycontin® with the U.S. Food & Drug Administration (FDA).
Following receipt of the notice from FDA that Impax’s ANDA had been
accepted for filing, Impax notified the New Drug Application holder
and patent owners of its paragraph IV certification.
On April 8, 2011, Purdue Pharma L.P., The P.F. Laboratories,
Inc., Purdue Pharmaceuticals L.P., Rhodes Technologies, Board of
Regents of the University of Texas System, and Grunenthal GBMH
filed suit for patent infringement against Impax Laboratories, Inc.
in the United States District Court for the Southern District of
New York. This action formally initiates the patent challenge
process under the Hatch-Waxman Act.
Once the ANDA is approved by FDA, Global Pharmaceuticals,
Impax’s generic division, will commercialize the products.
Oxycontin® is indicated for the management of moderate to severe
pain when a continuous, around-the-clock opioid analgesic is needed
for an extended period of time. According to Wolters Kluwer Health,
aggregate U.S. sales of Oxycontin® since launch were approximately
$2.8 billion for the twelve months ending January, 2011.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (“Impax”) is a technology based
specialty pharmaceutical company applying its formulation expertise
and drug delivery technology to the development of
controlled-release and specialty generics in addition to the
development of branded products. Impax markets its generic products
through its Global Pharmaceuticals division and markets its branded
products through the Impax Pharmaceuticals division. Additionally,
where strategically appropriate, Impax has developed marketing
partnerships to fully leverage its technology platform. Impax
Laboratories is headquartered in Hayward, California, and has a
full range of capabilities in its Hayward, Philadelphia and Taiwan
facilities. For more information, please visit the Company's Web
site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:To the extent any statements made in this news
release contain information that is not historical, these
statements are forward-looking in nature and express the beliefs
and expectations of management. Such statements are based on
current expectations and involve a number of known and unknown
risks and uncertainties that could cause the Company’s future
results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by
such forward-looking statements. Such risks and uncertainties
include, but are not limited to, the effect of current economic
conditions on the Company’s industry, business, financial position
and results of operations, the ability to maintain an effective
system of internal control over financial reporting, fluctuations
in revenues and operating income, the ability to successfully
develop and commercialize pharmaceutical products, reductions or
loss of business with any significant customer, the impact of
competition, the ability to sustain profitability and positive cash
flows, any delays or unanticipated expenses in connection with the
operation of the Taiwan facility, the effect of foreign economic,
political, legal and other risks on operations abroad, the
uncertainty of patent litigation, consumer acceptance and demand
for new pharmaceutical products, the difficulty of predicting Food
and Drug Administration filings and approvals, the inexperience of
the Company in conducting clinical trials and submitting new drug
applications, the ability to successfully conduct clinical trials,
reliance on alliance and collaboration agreements, the availability
of raw materials, the ability to comply with legal and regulatory
requirements governing the healthcare industry, the regulatory
environment, the ability to protect the Company’s intellectual
property, exposure to product liability claims and other risks
described in the Company’s periodic reports filed with the
Securities and Exchange Commission. Forward-looking statements
speak only as to the date on which they are made, and Impax
undertakes no obligation to update publicly or revise any
forward-looking statement, regardless of whether new information
becomes available, future developments occur or otherwise.
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