Because Oxtellar XR (oxcarbazepine extended-release) is protected by an unexpired patent, companies are not allowed to make a generic version of the drug at this time. After this patent expires in April 2027, it's possible that a generic product may become available. However, certain circumstances (such as lawsuits or patents for new uses) could delay the availability of a generic version of this drug.
Oxtellar XR is made by Patheon, Inc., and distributed by Supernus Pharmaceuticals, Inc. It is currently under the protection of patents that prevent any generic Oxtellar XR from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Oxtellar XR is set to expire in April 2027. 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, including things such as lawsuits or other patents for new Oxtellar XR uses. Once the patent expires, there may be several companies that manufacture a generic Oxtellar XR drug.
Is Oxcarbazepine a Generic Oxtellar XR?
No -- oxcarbazepine is the active ingredient in Oxtellar XR, 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.
It is worthwhile to note that oxcarbazepine is also the active ingredient in Trileptal® (oxcarbazepine), a prescription medication that is also approved to treat partial seizures. Unlike Oxtellar XR, Trileptal is approved for use alone or in combination with other anti-seizure medicines.
Oxtellar XR contains oxcarbazepine in a special extended-release tablet that allows it to be taken once a day. In contrast, Trileptal is taken twice a day.
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 May 13, 2013.
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