Also Amends Filing to Include Additional Strengths
September 26, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today
announced that Purdue Pharma L.P. has filed a lawsuit against the Company alleging
patent infringement related to IMPAX's filing of an Abbreviated New Drug Application
(ANDA) for a generic version of OxyContin® (Oxycodone HCl) 40 mg. Extended
Release Tablets. The lawsuit was filed in the United States District Court for
the Southern District of New York. In addition, the Company announced it has
amended its ANDA for the 40 mg. Tablets to include 10 mg. and 20 mg. Extended
Release Tablets. IMPAX Laboratories had previously announced that the FDA had
accepted the Company's ANDA for a generic version of OxyContin 80 mg. Extended
Release Tablets on February 26, 2002, and that Purdue Pharma had filed suit
alleging patent infringement for this formulation in April of this year.
Purdue Pharma L.P. markets OxyContin for the management of moderate to severe
pain. U.S. sales of OxyContin Extended Release 40 mg. Tablets were over $500
million in the 12 months ended June 30, 2002. U.S. sales of the 10 mg. and 20
mg. Extended Release Tablets also totaled more than $500 million during the
same time period. Total U.S. sales for all strengths in the same period were
over $1.5 billion.
"We are pleased to have ANDAs pending with FDA covering the full range
of strengths for generic OxyContin," stated Barry R. Edwards, Co-Chief
Executive Officer of IMPAX Laboratories. "In our filings with the FDA,
made under Paragraph IV of the Hatch-Waxman Amendments, we stated that all our
generic versions of OxyContin do not infringe Purdue Pharma L.P.'s listed patents.
We believe Purdue Pharma has filed its lawsuit against us as a tactic to delay
the availability of lower-priced generic drugs to consumers."
IMPAX currently has 16 ANDA filings pending at the FDA that address more than
$9.3 billion in U.S. branded product sales. Ten of these filings were made under
Paragraph IV of the Hatch-Waxman Amendments, and four of these 16 ANDAs have
received tentative approval from the FDA.
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 niche generics in addition to the development of branded
products. IMPAX markets its generic products through its Global Pharmaceuticals
division and intends to market its branded products through the IMPAX Pharmaceuticals
division. 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.