Because Onsolis (fentanyl buccal soluble film) is protected by patents, no generic version of this medication is available at this time. The first patent is set to expire in October 2016, which is the earliest predictable date that a generic Onsolis may be manufactured. However, lawsuits, other patents for specific uses, or other circumstances could come up to extend or shorten this exclusivity period.
Can I Buy Generic Onsolis?
Onsolis™ (fentanyl buccal soluble film) 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 small film that dissolves inside the cheek.
Onsolis is manufactured by Aveva Drug Delivery Systems for Meda Pharmaceuticals, Inc. It is currently under the protection of patents that prevent any generic Onsolis from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Onsolis is set to expire in October 2016. 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 Onsolis uses. Once the medication goes off-patent, there may be several companies that manufacture a generic Onsolis drug.
Is Fentanyl Buccal Soluble Film a Generic Onsolis?
No, fentanyl buccal soluble film is the active ingredient in Onsolis, 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 January 14, 2011.
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