Impax Laboratories Confirms Patent Challenge Relating to TRICOR® 48mg and 145mg Tablets
October 30 2009 - 10:45AM
Business Wire
Impax Laboratories, Inc. (NASDAQ:IPXL) today
confirms that it has initiated a challenge of the patents listed by
Abbott Laboratories in connection with its TRICOR® (fenofibrate)
tablets, 48 mg and 145 mg.
Impax filed its Abbreviated New Drug Application (“ANDA”)
containing a Paragraph IV certification for a generic version of
TRICOR® with the U.S. Food & Drug Administration (“FDA”).
Following receipt of the notice from the 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 October 29, 2009, Abbott Laboratories and Laboratoires
Fournier S.A. filed suit for patent infringement against Impax in
the United States District Court for the District of New Jersey.
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.
TRICOR® is indicated as adjunctive therapy to diet to reduce
elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase
HDL-C in adult patients with primary hypercholesterolemia or mixed
dislipidemia (Fredrickson Type IIa and IIb). TRICOR® is also
indicated as adjunctive therapy to diet for treatment of adult
patients with hypertriglyceridemia (Fredrickson Type IV and V
hyperlipidemia). According to Wolters Kluwer Health, aggregate U.S.
sales of TRICOR® were approximately $1.5 billion for the
twelve-month period ending August 2009.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. 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 and Philadelphia
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 Impax'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, possible adverse effects resulting from the delisting
of and suspension of trading in Impax's stock, Impax’s failure to
file any periodic reports subsequent to its quarterly report on
Form 10-Q for the quarter ended September 30, 2004, the SEC’s
revocation of the registration of Impax’s common stock under
section 12 of the Securities Exchange Act of 1934, the actual time
that will be required to,file a registration statement on Form 10
with respect to such stock, Impax's ability to obtain sufficient
capital to fund its operations, the difficulty of predicting FDA
filings and approvals, consumer acceptance and demand for new
pharmaceutical products, the impact of competitive products and
pricing, Impax's ability to successfully develop and commercialize
pharmaceutical products, Impax's reliance on key strategic
alliances, the uncertainty of patent litigation, the availability
of raw materials, the regulatory environment, dependence on patent
and other protection for innovative products, exposure to product
liability claims, fluctuations in operating results and other risks
detailed from time to time in Impax's filings 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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