Par Pharmaceutical Announces Court Ruling on Ondanestron Hydrochloride Orally Disintegrating Tablets
Posted on: Wednesday, 27 July 2005, 21:00 CDT
SPRING VALLEY, N.Y., July 27 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today announced that the U.S. District Court for the District of New Jersey has issued a summary judgment ruling that GlaxoSmithKline's U.S. Patent Nos. 5,578,628 (the '628 patent) and 4,753,789 (the '789 patent) for Zofran ODT(R) (ondansetron) Orally Disintegrating Tablets are valid, enforceable and infringed by Par's wholly-owned subsidiary, Kali Laboratories, Inc. Zofran ODT(R) 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 U.S. sales of Zofran ODT(R) are approximately $225 million. Kali intends to appeal the Court's decision.
Kali filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) in September 2002 seeking marketing clearance for its generic version of Zofran ODT(R). In October 2002, Kali's ANDA was accepted for filing by the FDA. GlaxoSmithKline did not file suit against Kali on U.S. Patent Nos. 5,955,488 and 6,063,802, which expire in May 2016. Par believes Kali was also the first to file on these composition patents and may be entitled up to 180 days of marketing exclusivity for the product. The '628 method of use patent expires August 16, 2005 and the '789 method of use patent expires December 24, 2006, following expiration of pediatric exclusivity. Par expects ondansetron hydrochloride (HCl) orally disintegrating tablets (ODT) to be launched no later than December 2006.
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.
In June 2005, the FDA granted tentative approval for the company's ANDA for ondansetron HCl ODT in 4 mg and 8 mg strengths. A tentative approval reflects the FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of any patents or exclusivity periods accorded to the reference listed drug. A tentative approval does not allow the applicant to market the generic product and postpones the final approval until all patent/exclusivity issues have expired.
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, the first of which is Megace ES(R). Par currently manufactures, markets or licenses more than 90 prescription drugs. For press release and other company information, visit http://www.parpharm.com/.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Par Pharmaceutical Companies, Inc.
CONTACT: Stephen J. MockCecelia, or C. Heer, both of Par PharmaceuticalCompanies, Inc., +1-201-802-4000
Web site: http://www.parpharm.com/
Source: PRNewswire-FirstCall
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