There are currently no generic Niravam (orally disintegrating alprazolam) products available in the United States. The first patent for this medication is set to expire in June 2018, which is the earliest possible date that a generic version could be manufactured. It is important to note that alprazolam is a generic name for Niravam, which is not the same thing as a generic version of the drug.
Niravam is made by Cima Labs, Inc., for Azur Pharma, Inc. It is currently under the protection of patents that prevent any generic Niravam from being made in the United States.
When Will a Generic Version Be Available?
The patents for Niravam are set to expire in June 2018. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for specific Niravam uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Niravam drug.
Is Alprazolam a Generic Niravam?
No -- alprazolam is the active ingredient in Niravam, but is not a generic version of it. What can be confusing is that the active ingredient of a drug is often referred to as the "generic name."
The generic name is different from a generic version of a medicine. In order for there to be a generic version, the original medicine must have gone off-patent and another company besides the original manufacturer must make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed February 15, 2011.
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