There are currently no generic Aptivus products licensed for sale. The medication is currently under the protection of a patent that prevents any generic versions from being made in the United States. As soon as this patent expires in November 2014, however, a number of drug companies are expected to begin manufacturing a generic Aptivus drug.
Generic Aptivus: An Overview
Aptivus® (tipranavir) is a prescription HIV medication. It is a protease inhibitor and is approved only for use in combination with other HIV medications. Aptivus should always be used with ritonavir (Norvir®), another HIV medication that increases the level of Aptivus in the blood (which makes it more effective).
Aptivus is made by Boehringer Ingelheim Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic Aptivus from being manufactured in the United States.
When Will Generic Aptivus Be Available?
The first patent for Aptivus currently expires in November 2014. Although this patent originally was set to expire in May 2014, the manufacturer was given an extension for performing much-needed pediatric studies.
November 2014 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 2014. This could include such things as other patents for specific Aptivus uses or lawsuits. Once Aptivus goes off-patent, several companies will likely begin manufacturing a generic Aptivus drug.
Is Tipranavir the Same as Generic Aptivus?
No -- tipranavir is the active ingredient in Aptivus, 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 February 6, 2009.
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