The generic version of mifepristone is the non-proprietary chemical name for the drug. While the brand name, Mifeprex, was the original formulation available for medication abortion, the U.S. Food and Drug Administration (FDA) has since approved generic versions from different manufacturers. These generic alternatives contain the same active ingredient and are considered therapeutically equivalent to the brand-name drug, offering a more accessible and affordable option for patients.
The FDA Approves Generic Mifepristone
First Generic Approval: GenBioPro
On April 11, 2019, the FDA approved the first generic version of mifepristone for medical termination of early pregnancy. This approval was granted to GenBioPro, Inc., marking a significant milestone in expanding access to medication abortion. Before this, the brand-name Mifeprex, manufactured by Danco Laboratories, was the only form available in the U.S.. The FDA’s approval of GenBioPro’s version followed a review process to ensure it met the same high standards of safety, efficacy, and quality as the brand-name product.
Second Generic Approval: Evita Solutions
In late September 2025, the FDA quietly approved a second generic version of mifepristone, this time from the company Evita Solutions. This approval further expanded the market and increased patient options for medication abortion. The FDA affirmed that Evita Solutions' tablets are therapeutically equivalent to Mifeprex. The introduction of multiple generic manufacturers can lead to increased competition, potentially driving down costs and improving overall accessibility for patients.
Brand vs. Generic: Understanding the Differences
Generic and brand-name drugs often raise questions regarding their differences. The FDA's stringent approval process ensures that generic versions are bioequivalent and therapeutically equivalent to their brand-name counterparts. Here’s a detailed comparison:
| Feature | Brand-Name Mifeprex | Generic Mifepristone (GenBioPro, Evita Solutions) |
|---|---|---|
| Manufacturer | Danco Laboratories | GenBioPro, Inc.; Evita Solutions |
| FDA Approval | First approved September 28, 2000 | GenBioPro approved in 2019; Evita Solutions approved in 2025 |
| Cost | Typically higher; cost information is not publicly disclosed but providers report high costs | Expected to be lower due to market competition; GenBioPro has indicated a desire to drive down costs |
| Equivalence | The reference listed drug | Therapeutically equivalent and bioequivalent to Mifeprex |
| REMS Program | Subject to the single, shared Mifepristone REMS Program | Also subject to the single, shared Mifepristone REMS Program |
| Other Names | Also known as RU-486, especially in historical context | Also known by the generic name mifepristone; RU-486 refers to the active ingredient |
Therapeutic Equivalence and Safety
According to the FDA, generic drugs must contain the same active ingredient, strength, dosage form, and route of administration as their brand-name version. This ensures that the generic version of mifepristone will produce the same therapeutic effect and safety profile as Mifeprex. The FDA rigorously tests generic versions to confirm they are bioequivalent, meaning they are absorbed by the body at the same rate and to the same extent as the brand-name drug.
Cost and Accessibility
One of the main benefits of generic medications is their potential for lower costs, which can significantly improve patient accessibility. The introduction of multiple generic competitors, such as GenBioPro and Evita Solutions, can drive down market prices, making medication abortion a more affordable option for those without comprehensive insurance coverage. This expanded access is particularly important given that medication abortion accounts for a significant portion of all abortions in the United States.
The Role of Mifepristone in Medical Treatment
While commonly associated with medication abortion, mifepristone is also used for other medical conditions under a different brand name, Korlym.
Medical Termination of Early Pregnancy
In combination with misoprostol, generic mifepristone is indicated for the medical termination of an intrauterine pregnancy through 70 days gestation. Mifepristone works by blocking the hormone progesterone, which is essential for maintaining a pregnancy. Taking misoprostol 24 to 48 hours later causes the uterus to contract and empty.
Treatment of Cushing's Syndrome
The Korlym brand of mifepristone is used to treat adults with endogenous Cushing's syndrome who have high blood sugar levels (hyperglycemia). For this purpose, mifepristone blocks the effects of the hormone cortisol. This application is distinct from its use in pregnancy termination and requires separate branding and a different dosage regimen.
The Mifepristone REMS Program
Both brand-name Mifeprex and all generic versions of mifepristone for pregnancy termination are subject to a single, shared Risk Evaluation and Mitigation Strategy (REMS) program administered by the FDA. This program was implemented to ensure the medication's safe use and mitigate potential risks, such as serious bleeding or infection.
Key requirements of the REMS program include:
- Certified Prescribers: Healthcare providers who wish to prescribe mifepristone must be certified by the program.
- Patient Agreement Form: A patient agreement form must be discussed and signed by both the provider and the patient.
- Certified Pharmacies: Mifepristone may only be dispensed by certified pharmacies, including mail order pharmacies, that have completed a pharmacy agreement form.
Conclusion
What is the generic version of mifepristone? It is a therapeutically equivalent and more affordable alternative to the brand-name drug Mifeprex, approved by the FDA and manufactured by companies such as GenBioPro and Evita Solutions. The introduction of these generics has increased access and competition in the market, while still being regulated under the same stringent FDA safety protocols as the original. Patients can be confident that the generic versions offer the same safety and effectiveness for their intended medical purpose, whether for medical termination of early pregnancy or the management of Cushing's syndrome (Korlym). For more information on medication abortion, consult authoritative health resources.
