The wholly-owned subsidiary of Par Pharmaceutical Companies, Inc., Kali Laboratories, Inc., has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for ondansetron hydrochloride (HCl) orally disintegrating tablets (ODT) in 4 mg and 8 mg strengths.
Kali has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the product. Final approval follows expiration of the 30-month stay that was granted in accordance with the Hatch-Waxman Act. GlaxoSmithKline currently markets ondansetron HCl ODT under the brand name Zofran ODT. The product is used for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Annual US sales of Zofran ODT are approximately $225 million.
Under the terms of Kali's agreement with Pliva, Inc., Pliva has exclusive rights to market, sell and distribute ondansetron HCl ODT in the U.S. The product will be manufactured by Kali and the companies will split profits from the sales of the product.
According to the company release, Kali is currently involved in litigation with GlaxoSmithKline. In July 2005, the US District Court for the District of New Jersey issued a summary judgment ruling that GlaxoSmithKline's US Patent Nos. 5,578,628 (the '628 patent) and 4,753,789 (the '789 patent) for Zofran ODT are valid, enforceable and infringed by Kali. Kali is appealing the decision. GlaxoSmithKline did not file suit against Kali on US Patent Nos. 5,955,488 and 6,063,802, which expire in May 2016. Kali was also the first to file on these composition patents. The '628 method of use patent expired August 16, 2005 and the '789 method of use patent expires December 24, 2006, following expiration of paediatric exclusivity. Par expects ondansetron HCl ODT to be launched no later than December 2006.
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, the first of which is Megace ES, for specialty markets.