By Sherri Oslick --
Ortho-McNeil, Inc. announced late last week that it has settled its lawsuit against Par Pharmaceutical Companies, Inc. and its subsidiaries, Par Pharmaceutical, Inc. and Kali Laboratories, Inc., over the patent covering Ortho's Ultracet® (tramadol hydrochloride and acetaminophen, used to treat acute pain).
As part of the settlement agreement, Par/Kali entered into a consent judgment admitting to infringement and conceding that the patent-in-suit, RE39,221, is valid and enforceable. Ortho will
receive a lump sum for past damages, and Par will pay royalties going forward until November 15, 2007, the date on which the parties agreed Par/Kali will exit the market.
Ortho filed its suit against Par/Kali on July 31, 2006 in the District Court of New Jersey (2:06-cv-03533) based on defendants' manufacture and sale of a generic version of Ultracet®. Par/Kali's ANDA, including a Paragraph IV certification, was approved by the FDA on April 21, 2005.
On the day before announcing its settlement with Par/Kali, Ortho filed suit against Apotex for infringement of RE39,221 based on Apotex's recent ANDA filing seeking approval to market generic Ultracet®, as reported here. RE39,221 will expire on August 9, 2011.
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