There is currently no generic Minivelle patch approved in the United States. A patent prevents any generic versions of the medication from being made until at least April 2020. However, certain circumstances could come up that may affect the availability of generic Minivelle, such as lawsuits or other patents for new uses.
Can I Buy Generic Minivelle?
Minivelle™ (estradiol patch) is a prescription estrogen hormone replacement medication. It is approved for treating menopausal symptoms, such as hot flashes and night sweats.
Minivelle is made by Noven Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic Minivelle from being sold in the United States.
When Will a Generic Version Be Available?
The first patent for Minivelle is set to expire in April 2020. 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 things such as lawsuits or other patents for new Minivelle uses. Once the patent expires, several companies may begin manufacturing a generic Minivelle drug.
What About Generic Estradiol Patches?
None of the generic estradiol patches currently available are equivalent to Minivelle. No other product (generic or otherwise) is equivalent to Minivelle, even though other patches contain the same active ingredient in the same strength. Most likely, these other patches have not been shown to release estradiol at the same rate or for the same length of time as Minivelle patches.
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 March 11, 2013.
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