Par Pharmaceutical Announces Agreement with Ortho-McNeil to Settle Ultracet Patent Litigation
WOODCLIFF LAKE, N.J., July 19, 2007 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced it has entered into a settlement and license agreement with Ortho-McNeil Pharmaceutical, Inc. that resolves patent litigation related to Ortho-McNeil's Ultracet(R) product, thereby eliminating the inherent uncertainty and costs of litigation. Under the terms of the settlement, Par will pay Ortho-McNeil a royalty on sales of its generic tramadol/acetaminophen product through November 15, 2007 by which time Par will cease selling its generic product. Par will also pay Ortho-McNeil royalties on sales from August 2006 to June 2007. Ultracet(R) (37.5 mg tramadol HCl/325 mg acetaminophen tablets) is indicated for the short-term (five days or less) management of acute pain. Par received approval from the U.S. Food and Drug Administration and began marketing its generic version of Ultracet(R) in April 2005.
In accordance with the settlement and license agreement, the pending patent litigation between Ortho-McNeil, Par and Par's wholly-owned subsidiary, Kali Laboratories, Inc., in the United States District Court for the District of New Jersey will be concluded. As part of the settlement, Par is entering into a consent judgment on the validity, enforceability and infringement of the Reissue Patent No. RE39221.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.
Safe Harbor Statement
Certain statements in this press release constitute "forward-looking statements" within the meaning of 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 essentially forward- looking and as such, are subject to risks and uncertainties, including the extent and impact of litigation arising out of the accounting issue described in this and prior public announcements, including the lawsuit brought against the company by the trustee for the company's Senior Subordinated Convertible Notes seeking an accelerated payment of the $200 million of principal of and accrued interest on the notes or, in the alternative, damages, the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against the company, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission (SEC), such as the company's reports on Form 10-K, Form 10-Q, and Form 8-K, and amendments thereto. The company can make no assurance as to the potential effects of the restatement, including the effects of any investigations, informal or otherwise, conducted by the SEC, or other entities, or lawsuits filed against the company in connection therewith. Any forward-looking statements included in this press release are made as of the date here of only, based on information available to the company as of the date hereof, and, subject to any applicable law to the contrary, the company assumes no obligation to update any forward-looking statements.
CONTACT: media, Peter Wolf, +1-201-802-4000, or investors, Stephen J.Mock, +1-201-802-4000, both of Par Pharmaceutical Companies, Inc.
Web site: http://www.parpharm.com/
Ticker Symbol: (NYSE:PRX)
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Posted: July 2007