The first patent for Faslodex expired in 2007. However, no generic companies have decided to challenge a later patent that will protect Faslodex for several years. At this point, it appears that no generic Faslodex will be available until at least 2021.
The drug is manufactured by AstraZeneca Pharmaceuticals. It is currently under the protection of a patent that prevents any generic Faslodex from being manufactured in the United States.
When Will Generic Faslodex Be Available?
The first patent for Faslodex expired in December 2007. However, it appears that a later patent (set to expire in January 2021) will protect Faslodex from generic competition for quite a while. The expiration date for the first patent has passed, and no generic companies have decided to challenge the 2021 patent. At this point, it appears that no generic Faslodex will be available until at least 2021. This could change, however, if any generic manufacturers choose to legally challenge the 2021 patent at an earlier date.
Is Fulvestrant a Generic Faslodex?
No -- fulvestrant is the active ingredient in Faslodex, but it is not a generic version of it. What can be confusing is that, oftentimes, the active ingredient of a 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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Faslodex [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP;2011 May.
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 16, 2007.
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