At this time, Prezista (darunavir ethanolate) is available as a brand-name drug only, despite the fact that its first patent has expired. The next patent is set to expire in February 2015. It's possible that a generic version could be introduced after this date, barring any lawsuits or other patents for specific uses of the drug.
Generic Prezista: An Overview
Prezista™ (darunavir ethanolate) is a prescription AIDS and HIV medication. It belongs to a class of medications known as protease inhibitors and is approved only to be used in combination with other HIV medications. Prezista should always be used with ritonavir (Norvir®), another HIV medication that increases the level of Prezista in the blood, making it more effective.
Prezista is made by Ortho Biotech Products. It is currently under the protection of patents that prevent any generic Prezista from being manufactured in the United States.
When Will Generic Prezista Be Available?
The first patent for Prezista already expired in February 2013. Yet, no generic versions are available. This strongly suggests that one or more later-expiring patents are still protecting the drug from generic competition. The next patent set to expire will do so in February 2015.
This is the earliest possible date that a generic version of Prezista could become available. However, other circumstances could come up to extend the exclusivity period of the medicine beyond 2015. This could include such things as other patents for specific Prezista uses or lawsuits. Once the patent expires, several companies will likely begin manufacturing a generic Prezista drug.
Is Darunavir the Same as Generic Prezista?
No -- darunavir is the active ingredient in Prezista, but is not a generic version of it. 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 March 25, 2013.
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