At this time, Diclegis (doxylamine and pyridoxine) is available in brand-name form only. The drug is protected by patents that protect it from generic competition. The first of these patents is set to expire in June 2021. Although doxylamine and pyridoxine is sometimes called the "generic name" for Diclegis, it is not a generic version of it.
Can I Buy Generic Diclegis?
Diclegis® (doxylamine and pyridoxine) is a prescription medication approved for treating nausea and vomiting in pregnant women. It contains an antihistamine combined with vitamin B6.
Diclegis is made by Duchesnay, Inc. The drug is currently protected by patents that prevent any generic versions from being sold in the United States.
When Will a Generic Version Be Available?
The first patent for Diclegis is set to expire in June 2021. This is the earliest predictable date that a generic version of the drug could become available. However, this could change, depending on many factors, such as lawsuits or additional patents. Once Diclegis goes off-patent, there may be several companies that will manufacture a generic Diclegis drug.
Is Doxylamine and Pyridoxine a Generic Form of Diclegis?
No, doxylamine and pyridoxine are the active ingredients in Diclegis, 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 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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Diclegis [package insert]. Bryn Mawr, PA: Duchesnay USA, Inc.;2013 April.
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 25, 2013.
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