Impax Laboratories Confirms Patent Challenge Relating to Generic NUEDEXTA® 20 mg/10 mg
August 31 2011 - 8:30AM
Business Wire
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms
that it has initiated a challenge of the patents listed in
connection with Nuedexta® (dextromethorphan hydrobromide and
quinidine sulfate 20 mg / 10 mg) capsules.
Impax filed its Abbreviated New Drug Application (ANDA)
containing a paragraph IV certification for a generic version of
Nuedexta® 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 August 29, 2011, Avanir Pharmaceuticals, Inc., Avanir Holding
Company and Center for Neurologic Study filed suit for patent
infringement against Impax Laboratories, Inc. in the District of
Delaware. 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 product.
Nuedexta® is indicated for the treatment of pseudobulbar affect
(PBA). According to Wolters Kluwer Health, U.S. sales of Nuedexta®
were approximately $3.6 million for the seven-month period ending
July 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 or a reduction in sales of
any significant product, 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 pharmaceutical and healthcare
industries, 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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