A patent currently prevents the manufacturing of any generic versions of Zoladex (goserelin acetate implant). This patent is scheduled to expire in February 2021, which would be the earliest date that a generic version could become available. However, lawsuits or other patents for new uses of the drug may delay this process.
This medicine is manufactured by AstraZeneca Pharmaceuticals, LP. It is currently under the protection of a patent that prevents any generic Zoladex from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent is set to expire in February 2021. 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 specific Zoladex uses. Once the patent expires, there may be several companies that manufacture a generic Zoladex drug.
Is Goserelin Acetate a Generic Zoladex?
No -- goserelin acetate is the active ingredient in Zoladex, but it is 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
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 June 21, 2011.
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