Is Misoprostol Available in Generic Form?

October 10, 2025 •

3 min read

According to the U.S. Food and Drug Administration (FDA), generic versions of brand-name medications like Cytotec are considered to be as safe and effective as their originals. Yes, misoprostol is available in generic form and has been for many years. This availability offers a more affordable alternative for patients requiring this prostaglandin medication for its various uses.

Quick Summary

Misoprostol is a generic prescription medication that provides a more affordable alternative to the brand-name drug Cytotec. Generic misoprostol is approved for treating certain conditions and is considered equally safe and effective. It is available from various pharmaceutical manufacturers, leading to potential cost savings for patients.

Key Points

Generic Available: Misoprostol is available in a generic form, which is bioequivalent to the brand-name drug, Cytotec.
Cost Savings: Generic misoprostol is typically much less expensive than Cytotec, offering significant cost savings for patients.
FDA Approved: Multiple pharmaceutical companies manufacture and sell FDA-approved generic misoprostol.
Uses: The generic medication is approved for the same indications as the brand name, including preventing NSAID-induced ulcers.
Manufacturer Differences: While the active ingredient is identical, generic tablets may differ from Cytotec in appearance, shape, and inactive ingredients.
Verify with Pharmacist: Patients can inquire about available generic options when filling their prescription to ensure they receive the most cost-effective version.
Off-Label Uses: Misoprostol is also used off-label for several gynecological and obstetrical purposes, with generic versions being equally effective for these uses.

Understanding the Availability of Generic Misoprostol

Misoprostol is a synthetic prostaglandin E1 analog used for several medical applications. While it was originally marketed under the brand name Cytotec by Pfizer, its patent expired, paving the way for the production and sale of generic versions. Generic misoprostol is widely available and is chemically identical to the original brand-name product. The FDA requires that all generic medications demonstrate bioequivalence to their brand-name counterparts, meaning they contain the same active ingredient, strength, dosage form, and route of administration.

What are the main uses of misoprostol?

Gastric Ulcer Prevention: Misoprostol's FDA-approved use is to reduce the risk of gastric ulcers in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) for conditions like arthritis. NSAIDs can inhibit the production of protective prostaglandins in the stomach, and misoprostol replaces them, protecting the stomach lining.
Medical Abortion: Used off-label, often in combination with mifepristone, to terminate an early pregnancy.
Labor Induction and Cervical Ripening: Used off-label to soften and open the cervix and induce labor.
Postpartum Bleeding: Administered to control severe bleeding after childbirth.

Generic vs. Brand-Name: The Differences

The primary differences between generic misoprostol and the brand-name Cytotec relate to cost, appearance, and inactive ingredients. For the vast majority of patients and applications, these differences have no impact on safety or effectiveness.

Cost: Generic medications are typically significantly less expensive than brand-name drugs because the manufacturers do not need to recoup the costs of initial drug research, development, and marketing. With the numerous generic suppliers, competitive pricing drives the cost down further for consumers.
Inactive Ingredients: While the active ingredient (misoprostol) is identical, the inactive ingredients, such as fillers and binders, may differ. These variations do not affect the drug's therapeutic effect.
Appearance: The tablets may have different shapes, colors, or markings depending on the generic manufacturer. For example, the brand-name Cytotec 200 mcg tablet is white and hexagonal with specific markings, while generic versions from different companies may look different.
Manufacturer: The production of generic misoprostol is handled by several pharmaceutical companies, including ANI Pharmaceuticals, Micro Labs, and ACQ Pharma, among others.

Comparing Generic Misoprostol and Cytotec


Feature	Generic Misoprostol	Cytotec (Brand Name)
Active Ingredient	Misoprostol	Misoprostol
Cost	Typically significantly lower	Often higher due to branding and marketing
Safety & Effectiveness	Bioequivalent and therapeutically equivalent to the brand name.	The original brand-name product.
Appearance	Varies by manufacturer (e.g., shape, color, markings).	Specific appearance with consistent markings (e.g., hexagonal, white for 200mcg).
Manufacturers	Produced by multiple companies (e.g., ANI Pharms, Micro Labs).	Originally manufactured by Pfizer (Searle).
FDA Approval Date	Various dates depending on generic manufacturer.	Approved in 1988.

What influences the cost of misoprostol?

The price of misoprostol, whether generic or brand-name, is subject to several variables:

Insurance Coverage: A patient's insurance plan can significantly affect out-of-pocket costs, with many plans favoring lower-cost generics.
Pharmacy: Prices can differ between pharmacies, so using services like GoodRx or checking prices at different locations can help patients find the best deals.
Dosage and Quantity: The cost will vary depending on the prescribed strength and the number of tablets purchased.
Coupons and Savings Programs: Many pharmacies and third-party services offer coupons and discounts to reduce the cash price for misoprostol, particularly the generic version.

Conclusion

Yes, misoprostol is available in generic form, providing a safe, effective, and more affordable alternative to the brand-name drug Cytotec. Patients have access to a variety of FDA-approved generic versions from multiple manufacturers. When considering which version to use, consulting with a healthcare provider and pharmacist is advisable to understand the potential cost differences and verify insurance coverage, but patients can be confident that generic misoprostol offers the same therapeutic benefits as its brand-name counterpart. For individuals with a high risk of NSAID-induced ulcers or other approved uses, the availability of generic misoprostol is a key factor in ensuring accessible and affordable treatment.

Potential Outbound Link (Optional)

For more details on FDA-approved medications and generic drug programs, visit the FDA's official website.

Frequently Asked Questions

Yes, generic misoprostol is considered therapeutically equivalent to brand-name Cytotec. The FDA requires that all generic drugs demonstrate bioequivalence to the original, meaning they have the same active ingredient and produce the same therapeutic effect.

Generic drugs are cheaper because manufacturers do not have to repeat the extensive research and development process or marketing campaigns that the original brand-name company, Pfizer, did. This allows them to sell the medication at a lower cost.

Several companies manufacture generic misoprostol, including ANI Pharmaceuticals, ACQ PHARMA, and Micro Labs. The specific manufacturer you receive may depend on your pharmacy's supplier.

Yes, you can and should request the generic version when filling your prescription. If your doctor has prescribed Cytotec, your pharmacist will likely substitute it with the generic misoprostol unless the doctor specifies 'no substitution'.

The primary FDA-approved use of misoprostol is for the prevention of gastric (stomach) ulcers caused by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

No, generic and brand-name tablets are not required to look identical. The brand-name Cytotec has specific markings and appearance, while generic versions may vary in shape, color, and imprints depending on the manufacturer.

If your insurance plan has unusual coverage policies, you should discuss it with your doctor and pharmacist. They can help navigate options, as generic substitution is standard practice and often more affordable even without specific coverage.