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news.Par Pharmaceutical Companies' subsidiary, Kali Laboratories, has received final approval from the FDA to market a generic version of Ortho-McNeil's acute pain drug, Ultracet.
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Kali has been awarded 180 days of marketing exclusivity for being the first to file an abbreviated new drug application (ANDA) containing a paragraph IV certification for the product.
Ortho-McNeil Pharmaceutical, a Johnson and Johnson company, currently markets 37.5mg tramadol HCl/325mg acetaminophen tablets under the brand name Ultracet. The product is indicated for the short-term (five days or less) management of acute pain and has annual US sales of approximately $350 million.
Kali is currently involved in litigation with Ortho-McNeil, which has alleged that Kali’s product infringes a US patent. Kali has alleged that its product does not infringe this patent and that the patent is invalid and unenforceable.
Kali filed for a summary judgment of invalidity and non-infringement before the US District Court in New Jersey. These motions were filed in August 2004 and the parties are awaiting a decision by the Court.