At this time, Intelence (etravirine) is not available as a generic. Intelence is currently under the protection of patents that prevent any generic versions of the drug from being manufactured. The earliest possible date that a generic version could become available is November 2019, when the first patent expires.
Is a Generic Version of Intelence Available?
Intelence™ (etravirine) is a prescription HIV medication. It belongs to a group of medications known as non-nucleoside reverse transcriptase inhibitors (NNRTIs for short). It is approved to be used only in combination with other HIV medications and only in people who have developed resistance to other HIV medications.
Intelence is made by Tibotec, Inc. It is currently under the protection of patents that prevent any generic Intelence from being manufactured in the United States.
When Will Generic Intelence Be Available?
The first patent for Intelence currently expires in November 2019. This is the earliest predictable date that a generic version of Intelence could become available. However, there are other circumstances that could come up to extend or shorten the exclusivity period of Intelence. This could include such things as other patents for specific Intelence uses or lawsuits. Once the medication goes off patent, there may be several companies that will begin manufacturing a generic Intelence drug.
Is Etravirine a Generic Intelence?
The answer is no. Etravirine is the active ingredient in Intelence but is not a generic version of the medicine. What can be confusing is that, oftentimes, the active ingredient of any 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 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 November 24, 2008.
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