Healthcare Industry News: minocycline
News Release - January 15, 2008
IMPAX Announces Lawsuit Related to Generic Version of SOLODYN(R)HAYWARD, Calif.--(HSMN NewsFeed)--IMPAX Laboratories, Inc. (OTC:IPXL ) today announced that it has filed a lawsuit against Medicis Pharmaceutical Corporation in the United States District Court for the Northern District of California requesting a declaration that IMPAX does not infringe any valid claims of U.S. Patent No. 5,908,838 related to IMPAX’s filing in October 2007 of an Abbreviated New Drug Application (ANDA) for minocycline hydrochloride extended-release tablets, a generic version of SOLODYN®.
IMPAX's ANDA does not contain any patent certification under Paragraph IV of the Hatch-Waxman amendments because no patents for the SOLODYN® product are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U. S. Food and Drug Administration. Certain antibiotic products are not subject to these Hatch-Waxman procedures and, therefore, do not have patents listed in the Orange Book and are not subject to the patent certification requirements.
Medicis Pharmaceutical Corporation markets SOLODYN® tablets for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. U.S. sales of SOLODYN® tablets were approximately $216.7 million in the 12 months ended November 30, 2007.
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, the SEC proceeding to determine whether to suspend or revoke the registration of IMPAX's securities under section 12 of the Securities Exchange Act, IMPAX's delay in filing its 2004 Form 10-K, its Form 10-Q for each of the first three quarters of 2005, 2006, and 2007, its Form 10-K for 2005 and 2006, the actual time that will be required to complete the filing of IMPAX's delinquent periodic reports, 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.
Source: IMPAX Laboratories
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