Samsca (tolvaptan) is a brand-name medicine that is not currently available in generic form. Although the first patent for the drug has expired, another patent and exclusivity rights are in place until May 2015. This is the earliest estimated date that a generic Samsca product might become available.
Can I Buy Generic Samsca?
Samsca® (tolvaptan) is a prescription medication approved for treating low blood sodium levels. It is used when blood sodium levels do not need to be increased right away.
Samsca is made by Otsuka Pharmaceutical Co., Ltd. It is currently protected by patents and exclusivity rights that have not yet expired and is, therefore, not available as a generic product.
When Will a Generic Version Be Available?
The first patent for Samsca expired in November 2012. However, the medication is protected by another patent and exclusivity rights until May 2015. This is the earliest predictable date that a generic version of the drug could become available.
However, other circumstances could come up to delay or shorten this exclusivity period. This includes such things as lawsuits or other patents for new Samsca uses. Once the patents and exclusivity rights expire, there may be several companies that manufacture a generic Samsca drug.
Is Tolvaptan a Generic Form of Samsca?
No -- tolvaptan is the active ingredient in Samsca, not a generic version of it. What can be confusing is that the active ingredient of a drug is often 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, 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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Samsca [package insert]. Rockville, MD: Otsuka America Pharmaceutical, Inc.;2012 November.
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 March 29, 2013.
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