Patents and exclusivity rights currently prevent companies from making a generic Oseni (alogliptin and pioglitazone) product. After these expire in March 2025, companies may be allowed to make generic versions of the drug. Although alogliptin and pioglitazone is often referred to as the "generic name" for Oseni, these are simply the active ingredients and not a generic version.
Oseni is made by Takeda Pharmaceuticals America, Inc. It is currently under the protection of patents and exclusivity rights that prevent generic Oseni from being manufactured in the United States.
When Will a Generic Version Be Available?
Takeda holds the exclusive rights to market Oseni in the United States until at least March 2025. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to delay or shorten this exclusivity period. This includes such things as lawsuits or other patents for new Oseni uses. Once the patents and exclusivity rights expire, there may be several companies that manufacture a generic Oseni drug.
Are Pioglitazone and Alogliptin a Generic Oseni?
No -- pioglitazone and alogliptin are the active ingredients in Oseni, 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
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 4, 2013.
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