Patents currently prevent the manufacturing of a generic Complera (emtricitabine/rilpivirine/tenofovir) in the United States. The first patent is scheduled to expire in March 2016, which is the earliest date a generic version might be available. Although there may be a generic version of this drug available from another country, you should not buy it, as you have no way of knowing what you're getting.
Complera is made by Gilead Sciences, Inc. It is currently under the protection of patents that prevent any generic Complera from being manufactured in the United States.
However, if you search the Internet for "generic Complera," you may find a number of companies selling it. The fact is that these medicines may be fake, substandard, and potentially dangerous. There may be generic Complera available from another country, but there is really no way of knowing whether you are actually getting a genuine product. Therefore, you should not buy any generic Complera until there is an approved generic available.
When Will a Generic Version Be Available?
The first patent for Complera is set to expire in March 2016. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for specific Complera uses. Once Complera goes off-patent, there may be several companies that will manufacture a generic Complera drug.
It is worth noting that predicting when generic version of combination medications (medications that contain more than one active ingredient), like Complera, is difficult. Some of the patents may be for just one of the ingredients. Some may be for the combination. It is altogether possible that Complera will be protected from generic competition well beyond 2016.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Complera [package insert]. Foster City, CA: Gilead Sciences, Inc.;2013 December.
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 October 7, 2011.
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