Abstral (fentanyl sublingual tablets) is not available in generic form at this time. The first patent for this medication is set to expire in September 2019, which is the earliest possible date that a generic version could be manufactured. Fentanyl sublingual tablets are a generic name for Abstral, which is not the same thing as a generic version of the drug.
Can I Buy Generic Abstral?
Abstral® (fentanyl sublingual tablets) is a prescription narcotic opioid approved to treat intense bursts of pain (called "breakthrough pain") in people with cancer who are already taking regularly scheduled opioid medication for their constant pain. It comes in the form of a tablet that is dissolved under the tongue.
Abstral is manufactured by Novartis Consumer Health, Inc., for ProStrakan, Inc. It is currently under the protection of a patent that prevents any generic Abstral from being manufactured in the United States.
When Will a Generic Version Be Available?
It is difficult to determine when a generic version of Abstral will be available. The current patents for Abstral are set to expire in September 2019. Normally, this would be 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 Abstral uses. Once the patent expires, there may be several companies that manufacture a generic Abstral drug.
Are Fentanyl Sublingual Tablets a Generic Abstral?
No, fentanyl sublingual tablets are the active ingredient in Abstral, but are 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 April 15, 2011.
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