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Generic Glucotrol XL Tablets Approved
CORONA, Calif., Sept. 9 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for glipizide extended-release tablets in the 5 mg strength. Additionally, the company received tentative approval for the 10 mg strength. Glipizide extended-release tablets is the generic version of Pfizer Inc.'s Glucotrol XL® and is indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with type 2 diabetes after an adequate trial of dietary therapy has proved unsatisfactory. Glucotrol XL® sales were approximately $320 million for 2002, according to IMS data.
Watson will have generic market exclusivity on the 5 mg strength as a result of being the first to file an ANDA prior to the expiration of patents owned by ALZA Corporation. In July 2002, Watson filed an ANDA with the FDA on its glipizide extended-release product and certified that it did not infringe ALZA's patents on the product. ALZA, together with Pfizer, Inc., the marketer of Glucotrol XL®, filed suit against Watson on December 18, 2002 in the U.S. District Courts of New Jersey and Nevada, pursuant to the Hatch Waxman Act. The lawsuits were subsequently dismissed without prejudice on April 16, 2003 and April 22, 2003, triggering the beginning of Watson's 180-day exclusivity period. Watson's exclusivity period on the 5 mg product will expire on October 22, 2003. Watson expects to launch its 5 mg glipizide extended- release product in the fourth quarter 2003. The approval and launch of Watson's 10 mg dose is contingent on the expiration of another ANDA applicant's exclusivity period.
Source: Watson Pharmaceuticals, Inc.