Patents currently prevent the manufacturing of any generic versions of Nitrostat (nitroglycerin tablets) at this time. The first patent is scheduled to expire in September 2018, which would be the earliest date that a generic version could become available. Although there used to be other versions of nitroglycerin tablets, they were unapproved and thus removed from the market.
Can I Buy Generic Nitrostat?
Nitrostat® (nitroglycerin tablets) is a prescription medication used to treat chest pain (angina). It belongs to a group of medications known as nitrates. It is mostly used to relieve angina attacks, although it can also be used right before certain activities that are likely to produce chest pain.
Nitrostat is made by Pfizer, Inc. It is not available in generic form.
When Will a Generic Version Be Available?
The first patent for Nitrostat is set to expire in September 2018. 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 new Nitrostat uses. Once the patent expires, there may be several companies that manufacture a generic Nitrostat drug.
What Happened to the Generic Versions?
Years ago, there were numerous, unapproved nitroglycerin tablets available on the market. However, the United States Food and Drug Administration (FDA) "cracked down" on these unapproved products, and they are no longer available. Nitrostat is the only nitroglycerin tablet approved and available in the United States at this time.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Nitrostat [package insert]. New York, NY: Pfizer, Inc.;2010 January.
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 May 17, 2011.
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