FDA Approves Generic Omeprazole

First Marketing of Cost-Saving Drug Product to Begin

November 1, 2002 -- The Food and Drug Administration today approved the Kremers Urban Development Company (KUDCo) abbreviated new drug application (ANDA) for 10 and 20 mg. Omeprazole Delayed-Release Capsules. This approval will permit the first marketing of a generic omeprazole product to compete with AstraZeneca LP's Prilosec for the treatment of certain gastrointestinal conditions.

"The FDA's action represents a win-win for patients all across America. For those who are successfully taking this prescription, it means potential savings and for those who could not afford the brand name drug, it means greater access to a successful medication at a lower cost, " said Secretary of Health and Human Services Tommy G. Thompson.

FDA assures that a generic drug is as safe and effective as the brand name drug, and that it is manufactured to the same high quality standards. In addition, the generic drug is identical to the brand name drug in dosage form, strength, route of administration and most labeled uses.

Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

"American patients and health care professionals can be assured that any generic drug FDA approves meets the same high standards for quality as the innovator drug," said FDA Deputy Commissioner Dr. Lester M. Crawford. To gain FDA approval, a generic drug must:

  • contain the same active ingredients as the innovator drug (inactive ingredients may vary) 

  • be identical in strength, dosage form, and route of administration 

  • have some of the same use indications 

  • be bioequivalent (Generic drugs use the same active ingredients and are shown to work the same way in the body. Therefore they have the same risk-benefit profile as their brand-name counterparts.) 

  • meet the same batch requirements for identity, strength, purity, and quality 

  • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products KUDCo's ANDA is not the first approved generic omeprazole; it is, however, the first approval of a generic omeprazole that does not infringe patents held by AstraZeneca.

FDA approved an Andrx Pharmaceuticals, Inc., ANDA for omeprazole in November 2001, but Andrx has not been able to market its generic omeprazole because of patent infringement concerns.

Andrx and Genpharm, Inc., shared eligibility for 180-day exclusivity for generic omeprazole. This exclusivity never began. Andrx and Genpharm have relinquished their eligibility for exclusivity to permit FDA approval of other generic omeprazole products. Therefore there will be no 180-day exclusivity for any 10 or 20 mg generic omeprazole products.

According to company representatives, KUDCo is currently preparing to launch its 10 and 20 mg. generic omeprazole products.

The above information has been provided with the kind permission of the Food and Drug Administration press release #P02-45, November 1, 2002.

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Last Editorial Review: 11/7/2002