Certain patents protecting Vandazole (metronidazole vaginal gel) prevent other companies from making a generic version of this medication. The first patent for this drug is set to expire in September 2024, and this is the earliest predictable date a generic version could be available. However, this is just an estimated date, as lawsuits or new patents may delay the availability of a generic version.
Brand-name Vandazole is made by Upsher-Smith Laboratories, Inc. This medication is protected from generic competition by patents that have not yet expired.
When Will a Generic Version Be Available?
Vandazole is expected to be protected from generic competition until at least September 2024, when the first patent is set to expire. This is the earliest predictable date that a generic version could become available. However, other circumstances could come up to delay or shorten the exclusivity period. This could include such things as lawsuits or patents for new Vandazole uses.
Is Metronidazole Vaginal Gel a Generic Vandazole?
No -- metronidazole is the active ingredient in Vandazole (as well as in a number of other medications), 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.
It is important to note that MetroGel-Vaginal® (metronidazole vaginal gel), a different brand-name product, is not considered equivalent to Vandazole because of slight differences in product absorption and effectiveness.
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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