Impax Laboratories Confirms Patent Challenge Relating to ORACEA® Delayed-Release Capsules, 40mg
September 21 2009 - 7:00AM
Business Wire
Impax Laboratories, Inc. today confirms that it has
initiated a challenge of the patents listed by Galderma
Laboratories, L.P. in connection with its ORACEA® (doxycycline)
delayed-release capsules, 40 mg.
Impax filed its Abbreviated New Drug Application (“ANDA”)
containing a paragraph IV certification for a generic version of
ORACEA® 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 September 18, 2009, The Research Foundation of State
University of New York; New York University; Galderma Laboratories
Inc.; and Galderma Laboratories, L.P. filed suit for patent
infringement against Impax in the United States District Court for
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.
ORACEA® is indicated for the treatment of only inflammatory
lesions (papules and pustules) of rosacea in adult patients.
According to Wolters Kluwer Health, U.S. sales of ORACEA® were
approximately $104 million for the twelve-month period ending July
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 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; ability to timely file periodic reports required by the
Exchange Act; ability to maintain an effective system of internal
control over financial reporting; ability to sustain profitability
and positive cash flows; ability to maintain sufficient capital to
fund operations; any delays or unanticipated expenses in connection
with the construction of our Taiwan facility; ability to
successfully develop and commercialize pharmaceutical products; the
uncertainty of patent litigation; consumer acceptance and demand
for new pharmaceutical products; the impact of competitive products
and pricing; the difficulty of predicting Food and Drug
Administration filings and approvals; inexperience in conducting
clinical trials and submitting new drug applications; reliance on
key alliance agreements; the availability of raw materials; the
regulatory environment; exposure to product liability claims;
fluctuations in operating results and other risks described in our
Annual Report on Form 10-K for the year ended December 31, 2008.
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.
Impax Laboratories, Inc. (delisted) (NASDAQ:IPXL)
Historical Stock Chart
From May 2024 to Jun 2024
Impax Laboratories, Inc. (delisted) (NASDAQ:IPXL)
Historical Stock Chart
From Jun 2023 to Jun 2024