Exclusivity rights currently prevent any company from making a generic Onfi (clobazam) product in the United States. These rights are scheduled to expire in October 2018, which is the earliest predictable date that a generic Onfi could become available. However, lawsuits or new patents for specific uses may delay the manufacturing of a generic version of this drug.
Onfi is manufactured by Catalent Pharma Solutions, LLC, for Lundbeck, Inc. It is currently under the protection of a patent that prevents any generic versions of Onfi from being manufactured in the United States.
When Will a Generic Version Be Available?
The exclusivity rights for Onfi (which are similar to patents but not exactly the same) are set to expire in October 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 new Onfi uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Onfi drug.
Is Clobazam a Generic Onfi?
No -- clobazam is the active ingredient in Onfi, 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 of a medicine, 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 21, 2012.
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