Faulding to Launch Etodolac Extended-Release 400 mg Tablets in the United States with 180-Day Generic Market Exclusivity

Business Wire,  August 2, 2000  

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Business Editors

ADELAIDE, South Australia--(BUSINESS WIRE)--Aug. 2, 2000

International pharmaceutical and health care company, F H Faulding & Co Limited (Faulding), today announced that its Faulding Pharmaceuticals division will be marketing the first generic version of Etodolac Extended-Release 400 mg tablets, the generic equivalent of Wyeth-Ayerst's Lodine(R) XL brand tablets, under its Purepac brand name in the United States. Etodolac is indicated for acute and long term use in the management of osteoarthritis and pain. Approval was obtained today from the Food and Drug Administration (FDA) to manufacture and market the product.

The product had brand name sales for the 12 months ended December 1999 of approximately USD 69 million. "Etodolac was approved by the FDA under Paragraph IV and Faulding is pleased to have exclusive rights to market the product for 180 days," noted Frank C Condella Jr, President and Chief Executive Officer of Faulding Pharmaceuticals.

Having the first filed Abbreviated New Drug Approval (ANDA), containing a certification of non-infringement with respect to certain patents covering the product, will entitle Faulding to receive the benefit of a 180-day period of generic market exclusivity for the product. The exclusivity period commences upon commercial launch of the product by Faulding, which is expected to occur this month.

Faulding is a worldwide health and personal care company, listed on the Australian Stock Exchange. Faulding's principal businesses are generic oral and injectable pharmaceuticals, consumer health products, the provision of distribution and retail management services to pharmacies and logistics management services to hospitals. Faulding's products are sold in over 70 countries.

ENDS (2 August 2000)

NOTE: Lodine(R)is a registered trademark of American Home Products Corporation

N.B. Faulding Company Announcements are posted to the Faulding website www.faulding.com

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