At this time, patents prevent the manufacturing of a generic version of Arcapta (indacaterol maleate). The first patent is scheduled to expire in October 2020, which would be the earliest date that a generic Arcapta could become available. However, lawsuits, other patents for new uses of the drug, or other circumstances could change this date.
Arcapta is manufactured by Novartis Pharmaceuticals Corporation. It is currently under the protection of a patent that prevents any generic Arcapta from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent is set to expire in October 2020. 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 Arcapta uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Arcapta drug.
Is Indacaterol a Generic Arcapta?
No -- indacaterol is the active ingredient in Arcapta, but it 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 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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Arcapta [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation;2011 July.
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 August 10, 2011.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click