SPRING VALLEY, N.Y. — Par Pharmaceutical Companies, Inc. recently announced that its wholly-owned subsidiary, Kali Laboratories, Inc., has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for tramadol hydrochloride (HCl) and acetaminophen tablets. Kali has been awarded 180 days of marketing exclusivity, commencing at launch, for being the first to file an ANDA containing a paragraph IV certification for the product. Ortho-McNeil Pharmaceutical, Inc. currently markets 37.5 mg tramadol HCl/325 mg 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 U.S. sales of approximately $350 million.
Kali is currently involved in litigation with Ortho-McNeil, who has alleged that Kali’s product infringes U.S. Patent No. 5,336,691. 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 U.S. District Court in New Jersey. These motions were filed in August 2004 and the parties are awaiting a decision by the Court.Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products for specialty markets and expects to introduce the first of these in 2005. Par currently manufactures, markets or licenses more than 85 prescription drugs.