HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that it has initiated a challenge of a patent listed by Shionogi Pharma, Inc. in connection with its Fenoglide® (fenofibrate) tablets, 40 and 120 mg.
Impax filed its Abbreviated New Drug Application (ANDA) for a generic version of Fenoglide® 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 and the listing of the patent in the FDA Publication, Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the "the Orange Book"), Impax submitted a paragraph IV certification to FDA and notified the New Drug Application holder and patent owner of its certification.
On April 28, 2010, Shionogi Pharma, Inc. and LifeCycle Pharma A/S 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. Based on the date of the paragraph IV certification, the Company believes that it is the first to file an ANDA with a paragraph IV certification and expects to be entitled to 180 days of market exclusivity.
Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialize the products.
Fenoglide® 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 hyperlipidemia or mixed dyslipidemia. Fenoglide® is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. According to Wolters Kluwer Health, U.S. sales of Fenoglide® were approximately $36 million for the twelve-month period ending February 2010.
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, 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, results of operations and market value of its common stock, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, reductions or loss of business with any significant customer, the impact of competitive pricing and products and regulatory actions on the Company’s products, the ability to sustain profitability and positive cash flows, the ability to maintain sufficient capital to fund operations, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the ability to successfully develop and commercialize pharmaceutical products, 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, reliance on key alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, 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.
Impax Laboratories, Inc.
Investor Relations and Corporate Communications
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INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical FDA