At this time, generic Daliresp (roflumilast) is not available. The brand-name medication is currently protected by an unexpired patent and possibly exclusivity rights. When these expire, a generic version could be introduced. However, other circumstances, such as lawsuits or other patents, may further delay the manufacturing of a generic version of the drug.
Daliresp is made by Nycomed GmbH for Forest Pharmaceuticals, Inc. It is protected by exclusivity rights that prevent a generic version from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Daliresp is currently set to expire in January 2015, although the drug may also be protected from generic competition by certain exclusivity rights (which are different from patents) that are set to expire in February 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 Daliresp uses or lawsuits.
Is Roflumilast a Generic Version of Daliresp?
No -- roflumilast is the active ingredient in Daliresp, 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 of a drug, 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):
Daliresp [package insert]. St. Louis, MO: Forest Pharmaceuticals, Inc.;2011 February.
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 29, 2011.
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