Andrx's ANDAs approval

Andrx Corporation from Fort Lauderdale, FL, US, has entered into an agreement with Impax Corporation and a subsidiary of Teva Pharmaceutical Industries pertaining to a pending Abbreviated New Drug Applications (ANDAs) for bioequivalent versions of Wellbutrin SR and Zyban (bupropion hydrochloride) 100 mg and 150 mg extended release tablets filed by Andrx, as well as by Impax.

Pursuant to Impax's existing strategic alliance agreement with Teva, Teva has US marketing rights to Impax's versions of these products. Wellbutrin SR and Zyban (GlaxoSmithKline products) had US sales of approximately $1.6bn for the twelve-month period ending March 31, 2003.

The parties believe that the Andrx ANDAs for the products are entitled, under the Hatch-Waxman Act, to a 180-day period of marketing exclusivity. Under the exclusivity transfer agreement Andrx will continue to seek approval of its ANDAs.

Andrx's ceo, Richard J Lane, said: 'Though Andrx is continuing to work towards resolving the FDA and USP issues that have to date delayed the approval of our ANDAs for generic versions of Wellbutrin SR and Zyban, this exclusivity transfer agreement better ensures that generic versions of these products will become available, thereby benefiting both consumers and our shareholders.'

Andrx and Impax have both obtained favourable summary judgment decisions that their formulations of the products do not infringe GlaxoSmithKline's patents. GSK, however, has appealed both decisions.