Oleptro (trazodone ER) is protected by patents, which prohibit a generic version of the drug from being manufactured. However, the first patent is set to expire in June 2020, which is the earliest predictable date that a generic Oleptro may be available. There are generic versions of immediate-release trazodone, but these drugs are not equivalent to Oleptro.
Oleptro is made by Labopharm Europe Limited. Currently, this medication is protected by patents that prevent any generic versions from being sold in the United States.
When Will a Generic Version Be Available?
The first patent for Oleptro currently expires in June 2020. This is the earliest predictable date that a generic version could become available.
However, there are other circumstances that could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for specific Oleptro uses. Once the drug goes off patent, there may be several companies that manufacture a generic Oleptro drug.
Is Trazodone a Generic Oleptro?
No -- trazodone is the active ingredient in Oleptro, but it is not a generic version of it. There are generic versions of immediate-release trazodone available, but these medications are not equivalent to Oleptro. What can be confusing is that oftentimes, the active ingredient of a drug is 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 would 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 April 2, 2010.
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