Although the first patent for Exforge HCT (amlodipine-valsartan-hydrochlorothiazide) has expired, no generic versions are available at this time. However, the drug's next patent is set to expire in 2017. 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.
Exforge HCT is made by Novartis Pharmaceuticals Corporation. It is currently under the protection of a patent that prevents any generic Exforge HCT from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Exforge HCT expired in September 2012. However, no generic versions are yet available. This strongly suggests that one or more later-expiring patents are still protecting the drug from generic competition.
The next Exforge HCT patent is set to expire in December 2017. This is the earliest predictable date that a generic version of Exforge HCT could become available. However, there are other circumstances that could come up to extend or shorten the exclusivity period of Exforge HCT. This could include such things as other patents for specific Exforge HCT uses or lawsuits.
Once Exforge HCT goes off patent, there may be several companies that will begin manufacturing a generic Exforge HCT drug.
For many people (depending on insurance coverage), it is less expensive to take Exforge HCT rather than the three medications separately, and you will benefit from the convenience of taking one tablet daily, rather than three.
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 October 24, 2012.
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