Although the first patents for Sustiva (efavirenz) have expired, no generic versions are available at this time. However, the drug's next patent is set to expire in September 2014. 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 Sustiva: An Overview
Sustiva® (efavirenz) is a prescription HIV and AIDS medication. Sustiva belong to a class of medications known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is approved to be used only in combination with other HIV medications.
Sustiva is made by Bristol-Myers Squibb Company. It is currently under the protection of patents that prevent any generic Sustiva from being manufactured in the United States. Yet, if you search the Internet for "generic Sustiva," you may find a number of companies selling it. The fact is that these medicines may be fake, substandard, and potentially dangerous. Generic Sustiva may be available from another country, but there is really no way of knowing whether you are getting genuine Sustiva. You should not buy any generic Sustiva until there is an approved version available.
When Will Generic Sustiva Be Available?
The first patents for Sustiva expired in August 2012 and November 2013. However, generic versions are not yet available. This strongly suggests that other patents or exclusivity rights are still providing significant protection against generic competition. The next patent set to expire will do so in September 2014. This is the earliest possible date that a generic version of the drug could become available.
However, other circumstances could come up to extend the exclusivity period beyond September 2014. This could include such things as other patents for specific Sustiva uses or lawsuits. Once the patent expires, several companies will likely begin manufacturing a generic Sustiva drug.
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 December 3, 2013.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click