Par receives FDA approval and marketing exclusivity for ondanestron tablets

By Angela McDaniels

Seattle, Nov. 21 - Par Pharmaceutical Cos. Inc. said its subsidiary Kali Laboratories Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ondansetron hydrochloride orally disintegrating tablets in 4 mg and 8 mg strengths.

Kali has been awarded 180 days of marketing exclusivity for being the first to file an application containing a paragraph IV certification for the product, the company said.

Final approval follows expiration of the 30-month stay that was granted in accordance with the Hatch-Waxman Act. GlaxoSmithKline currently markets ondansetron under the brand name Zofran ODT.

Par expects the tablets to be launched no later than December 2006.

Under the terms of Kali's agreement with Pliva Inc., a Zagreb, Croatia-based pharmaceutical company, Pliva has exclusive rights to market, sell and distribute the tables in the United States. The product will be manufactured by Kali and the companies will split profits from the sales of the product, Par said.

Ondansetron is used for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, certain radiotherapies and the prevention of postoperative nausea and vomiting.

In July 2005, the U.S. District Court for the District of New Jersey issued a summary judgment ruling that GlaxoSmithKline's U.S. patents for Zofran orally disintegrating tables are valid, enforceable and infringed by Kali. Kali is appealing the decision.

Annual U.S. sales of Zofran orally disintegrating tablets are approximately $225 million, the company said.

Par Pharmaceutical is based in Spring Valley, N.Y., and develops generic pharmaceuticals and an additional line of branded pharmaceutical products.

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