At this time, there are no generic versions of Edluar (zolpidem sublingual tablet) licensed for sale. This is because the sleep medication is currently under the protection of a patent that prevents any generic versions from being manufactured in the United States. The earliest predictable date that any generic Edluar product could become available is September 2018, when the patent expires.
Is a Generic Version of Edluar Available?
Edluar® (zolpidem sublingual tablet) is a prescription sleep medication. It is unique in that it comes as a fast-acting sublingual tablet. It is approved to treat insomnia that is characterized by trouble falling asleep, as opposed to trouble staying asleep.
Edluar is made by Recipharm Stockholm AB for Meda Pharmaceuticals, Inc. Currently, the medication is protected by a patent that prevent any generic versions from being manufactured and sold in the United States.
When Will Generic Edluar Be Available?
The first patent for Edluar currently expires in September 2018. This is the earliest predictable date that a generic version could become available. However, other circumstances could come up to extend or shorten the exclusivity period. This could include such things as lawsuits or other patents for specific Edluar uses. Once the patent expires, several companies should start manufacturing generic Edluar.
Is Zolpidem a Generic Edluar?
No -- zolpidem tartrate is the active ingredient in Edluar (as well as a few other medications), but is not a generic version of it. What can be confusing is that, oftentimes, the active ingredient of any drug is 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 such as Edluar, the original drug must have gone off-patent and another company besides the original manufacturer must make it.
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 July 7, 2009.
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