At this time, there are no approved generic Enjuvia (conjugated estrogens) products available in the United States. The patent for Enjuvia does not expire until February 2021, at which point a generic version of the drug may be manufactured. However, lawsuits or other patents for specific uses of Enjuvia may delay or shorten this date. Once the patent expires, several companies may begin manufacturing a generic Enjuvia medication.
Enjuvia Generic: An Overview
Enjuvia® (conjugated estrogens) is a mixture of several different synthetic (manufactured) estrogens. It is approved for treating menopausal symptoms, such as hot flashes, night sweats, or vaginal irritation or dryness.
Enjuvia is made by Duramed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic versions of Enjuvia from being manufactured or sold in the United States.
When Will Generic Enjuvia Be Available?
The first patent for Enjuvia currently expires in February 2021. This is the earliest expected date that a generic version of Enjuvia could become available. However, there are other circumstances that could come up to extend or shorten the exclusivity period of Enjuvia. This could include things such as lawsuits or other patents for specific Enjuvia uses. Once Enjuvia goes off patent, there may be several companies that manufacture a generic Enjuvia drug.
Is "Conjugated Estrogens" a Generic for Enjuvia?
The answer is no. "Conjugated estrogens" is the active ingredient in Enjuvia (as well as several other hormone therapy products), but is not a generic version of Enjuvia. 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 would 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 April 2, 2008.
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