At this time, Uceris (budesonide ER) tablets are available in brand-name form only. A generic version of the drug is not expected to become available until after the patents expire, which is not until June 2020. Unless there are lawsuits or new patents filed, companies may begin making generic Uceris products after the patents expire.
Uceris is made by Santarus, Inc. It is currently under the protection of patents that prevent any generic Uceris from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent is set to expire in June 2020. This is the earliest possible date that a generic version could become available.
However, other circumstances could come up to extend this exclusivity period. This could include such things as lawsuits or other patents for new Uceris uses. After the patent expires, there may be several companies that manufacture a generic Uceris drug.
Is Budesonide a Generic Uceris?
No -- budesonide is the active ingredient in Uceris (as well as several other medications), 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, 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):
Uceris [package insert]. San Diego, CA: Santarus, Inc.;2013 January.
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 March 6, 2013.
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