Impax Laboratories and ThoRx Laboratories Confirm Patent Challenge Relating to Generic OPANA® ER 5 mg, 7.5 mg, 10 mg, 15 mg, 20

  Impax Laboratories and ThoRx Laboratories Confirm Patent Challenge Relating
  to Generic OPANA® ER 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg

Business Wire

HAYWARD, Calif. -- November 16, 2012

Impax Laboratories, Inc. (NASDAQ: IPXL) and its wholly owned subsidiary, ThoRx
Laboratories, Inc., today confirm that they have initiated a challenge of the
patents listed in the Orange Book in connection with Opana® ER (oxymorphone
hydrochloride extended-release tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30
mg, and 40 mg).

ThoRx filed its Abbreviated New Drug Application (ANDA) containing a paragraph
IV certification for a generic version of Opana® ^ ER with the U.S. Food &
Drug Administration (FDA). Following receipt of the notice from FDA that
ThoRx’s ANDA had been accepted for filing, ThoRx notified the New Drug
Application holder and patent owner of its paragraph IV certification.

On November 14, 2012, Endo Pharmaceuticals Inc. and Grunenthal GMBH filed suit
for patent infringement against ThoRx Laboratories, Inc. and 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, intends to commercialize the product.

Opana® ER is indicated for the relief of moderate to severe pain in patients
requiring continuous around-the-clock opioid treatment for an extended period
of time. According to Wolters Kluwer Health, U.S. sales of Opana® ER were
approximately $90 million for the three-month period ending September 2012.

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, fluctuations in the Company’s revenues and
operating income, the Company’s ability to successfully develop and
commercialize pharmaceutical products, reductions or loss of business with any
significant customer, the impact of consolidation of the Company’s customer
base, the impact of competition, the Company’s ability to sustain
profitability and positive cash flows, any delays or unanticipated expenses in
connection with the operation of the Company’s Taiwan facility, the effect of
foreign economic, political, legal and other risks on the Company’s operations
abroad, the uncertainty of patent litigation, increased government scrutiny on
the Company’s agreements with brand pharmaceutical companies, consumer
acceptance and demand for new pharmaceutical products, the difficulty of
predicting Food and Drug Administration filings and approvals, the Company’s
inexperience in conducting clinical trials and submitting new drug
applications, the Company’s ability to successfully conduct clinical trials,
the Company’s reliance on third parties to conduct clinical trials and
testing, the availability of raw materials and impact of interruptions in the
Company’s supply chain, the use of controlled substances in the Company’s
products, disruptions or failures in the Company’s information technology
systems and network infrastructure, the Company’s reliance on alliance and
collaboration agreements, the Company’s dependence on certain employees, the
Company’s ability to comply with legal and regulatory requirements governing
the healthcare industry, the regulatory environment, the Company’s ability to
protect the Company’s intellectual property, exposure to product liability
claims, changes in tax regulations, the Company’s ability to manage the
Company’s growth, including through potential acquisitions, the restrictions
imposed by the Company’s credit facility, uncertainties involved in the
preparation of the Company’s financial statements, the Company’s ability to
maintain an effective system of internal control over financial reporting, any
manufacturing difficulties or delays, the effect of terrorist attacks on the
Company’s business, the location of the Company’s manufacturing and research
and development facilities near earthquake fault lines 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.

Contact:

Impax Laboratories, Inc.
Mark Donohue, 215-558-4526
Sr. Director
Investor Relations and Corporate Communications
www.impaxlabs.com
 
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