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Generic medications are alternate forms of the same medication as the original prescription drug. They are sold when the original drug maker’s patent expires. Although generic medications contain the same active ingredient (omeprazole in the case of Prilosec®), they are not necessarily identical to the original drug. They could be made with other or additional inactive ingredients. However, for most practical purposes, they produce the same result.

A generic form of Prilosec® was approved and first sold in November 2002, making available less expensive forms of the drug. Generic prescription capsules of omeprazole, the main active ingredient in Prilosec®, are available in the following strengths:

• 10 mg
• 20 mg
• 40 mg

To win approval by the U.S. Food and Drug Administration (FDA), a generic drug must:

• Contain the same active ingredient as the original drug
• Be the same in strength, dosage form, and route of administration
• Be used for some of the same purposes
• Work the same way biologically in the body
• Meet the same strict FDA standards of manufacturing

Generic Vs. Brand Medications

Generic medications sell for less than the original brand medication because competing manufacturers don’t have to go to the expense of research and development to produce the drug.

When a medicine is first made, the manufacturer typically is protected by a patent for 17 years, guarding the company from competition and allowing it to make a profit and benefit from the research and development that it put into producing the medication.

Bone Fractures and Generic Prilosec®

Generic forms of Prilosec® containing omeprazole, the same active ingredient, may pose the same risk of fractures of the spine, hip and wrist, as the original drug.

On May 25, 2010, the FDA warned healthcare professionals and patients of the possible risks of these fractures when taking omeprazole in high doses or for extended periods of time. The FDA advised health care professionals to consider prescribing the drug in lower doses or for shorter periods of time.

Manufacturers were required by the FDA to make revisions to labels of both prescription and over-the-counter Prilosec®. The risk of fractures may be the same for persons taking the generic version as the original version of the drug because they both contain omeprazole.

Contact a Prilosec® Lawyer

If you have had bone fractures after taking Prilosec®, you should contact a Prilosec® lawyer to explore your options for being compensated by the drug’s manufacturer.