Amarin Corporation plc has confirmed that its Swedish subsidiary, Amarin Development AB, has developed a generic formulation of glipizide extended release tablets, as part of an agreement with Watson Pharmaceuticals Inc. Glipizide extended release tablets are marketed in the United States under the trade name Glucotrol XL by Pfizer Inc. Watson announced on 27th December 2002 that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its generic version of Glucotrol XL tablets 5 mg and 10 mg.
"This collaboration with Watson Pharmaceuticals demonstrates Amarin's capability of developing technically challenging products such as generic Glucotrol XL. The Watson collaboration, plus other collaborations, including Tanabe for morphine in Japan, demonstrate the strength of Amarin's product development capability," said Rick Stewart, chief executive officer of Amarin.
Glucotrol XL (glipizide extended release tablets) is indicated as an adjunct to diet for the control of hyperglycemia in patients with type-2 diabetes. Pfizer reported U.S. Glucotrol XL sales of approximately $265 million for the twelve months ending September 30, 2002.