Misoprostol - Generic Drug Details

What are the generic drug sources for misoprostol and what is the scope of patent protection?

Misoprostol is the generic ingredient in two branded drugs marketed by Pfizer, Acq Pharma, Ani Pharms, Micro Labs, and Novel Labs Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for misoprostol. Seventeen suppliers are listed for this compound.

Summary for misoprostol

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	484
Patent Applications:	8,384
Drug Prices:	Drug price trends for misoprostol
What excipients (inactive ingredients) are in misoprostol?	misoprostol excipients list
DailyMed Link:	misoprostol at DailyMed

See drug prices for misoprostol

See drug sales revenues for misoprostol

Recent Clinical Trials for misoprostol

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Western Galilee Hospital-Nahariya	NA
Northwestern University	PHASE4
Planned Parenthood Association of Utah	PHASE4

See all misoprostol clinical trials

Pharmacology for misoprostol

Drug Class

Prostaglandin E1 Analog

Medical Subject Heading (MeSH) Categories for misoprostol

Abortifacient Agents, Nonsteroidal

Anti-Ulcer Agents

Oxytocics

Anatomical Therapeutic Chemical (ATC) Classes for misoprostol

A02BB	Prostaglandins
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

G02AD	Prostaglandins
G02A	UTEROTONICS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for misoprostol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Micro Labs	MISOPROSTOL	misoprostol	TABLET;ORAL	216872-002	Oct 17, 2022	AB	RX	No	No
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990	AB	RX	Yes	No
Novel Labs Inc	MISOPROSTOL	misoprostol	TABLET;ORAL	091667-001	Jul 25, 2012		DISCN	No	No
Novel Labs Inc	MISOPROSTOL	misoprostol	TABLET;ORAL	091667-002	Jul 25, 2012		DISCN	No	No
Acq Pharma	MISOPROSTOL	misoprostol	TABLET;ORAL	210201-002	Jul 2, 2019	AB	RX	No	No

Expired US Patents for misoprostol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990	4,301,146
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	3,965,143
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	4,459,310
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	4,301,146
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	4,060,691

Market Dynamics and Financial Trajectory for Misoprostol

Last updated: February 19, 2026

What is the current global market size and growth rate for misoprostol?

The global misoprostol market was valued at approximately USD 220 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6% from 2023 to 2030, reaching an estimated USD 350 million by 2030 [1].

Which factors drive the demand for misoprostol?

Several key factors contribute to the increasing demand:

• Expanding access to reproductive health services. Misoprostol is used for medical abortions and post-partum hemorrhage management. As access improves in emerging markets, demand rises.
• Government policies and regulatory approval. Countries such as India, Nigeria, and Mexico have approved the drug for reproductive health uses, expanding its authorized market.
• Preference for non-invasive procedures. Medical management of pregnancy termination using misoprostol offers a less invasive alternative to surgical methods.
• Training and awareness initiatives. Efforts to educate healthcare providers increase proper usage and broaden distribution channels.

What are the key market segments and geographic trends?

By Application

• Medical abortion. Responsible for 60% of sales, driven by regulations and access.
• Post-partum hemorrhage. Growing due to maternal health initiatives in developing countries.
• Gastric ulcers. Declining segment owing to newer therapies.

By Region

Region	Market Share (2022)	CAGR (2023–2030)	Notes
Asia-Pacific	50%	7%	Major growth driven by India, China, and Southeast Asia
North America	20%	4%	Stable, with regulatory restrictions in some states
Europe	15%	4.5%	Market mature; growth driven by hospital procurement
Africa	10%	8%	Rapid expansion, increased access in Nigeria and Kenya

Who are the leading manufacturers and what is their financial performance?

Several companies dominate manufacturing:

• Fresenius Kabi. Revenue approximately USD 4 billion in 2022; offers misoprostol as part of reproductive health portfolios.
• Sun Pharmaceutical Industries. Revenue close to USD 4.4 billion in 2022; produces both branded and generic misoprostol.
• Niton. Specialized generics with revenues around USD 200 million; focused on emerging markets.

Pricing and Revenue

Average wholesale price (AWP) varies globally:

• US: USD 1.50 per tablet (100 mcg)
• India: USD 0.25 per tablet

Sales volumes depend on regional approvals, with some markets witnessing annual sales upticks of 8-10% in high-growth regions.

What are the regulatory and patent considerations impacting the market?

• Misoprostol is off-patent globally. It has been available as a generic since 2001.
• Several countries have regulatory restrictions or require special licensing, limiting market penetration.
• Some manufacturers face legal challenges related to its use for abortion, affecting supply chains.

What are the key risks and future opportunities?

Risks:

• Regulatory restrictions, particularly in developed nations.
• Competition from newer therapies for postpartum hemorrhage.
• Legal challenges restricting distribution.

Opportunities:

• Expansion in low- and middle-income countries through global health initiatives.
• Inclusion in essential medicines lists, facilitating procurement negotiations.
• Development of combination therapies, such as misoprostol with mifepristone.

What are the financial trends and forecast considerations?

Revenue growth is expected to remain steady, driven chiefly by emerging markets' demand for reproductive health interventions. Market penetration will be shaped by regulatory changes and public health policies. Competitive dynamics will likely favor manufacturers with broad distribution networks and compliance infrastructure.

Key Takeaways

• The misoprostol market is projected to grow at 6% CAGR through 2030, reaching USD 350 million.
• Asia-Pacific dominates the market, with rapid expansion in Africa and Latin America.
• Generic production is widespread, with prices varying regionally.
• Regulatory and legal considerations present significant risks; markets with supportive policies offer growth opportunities.
• Revenue is mainly driven by applications in medical abortion and postpartum hemorrhage management.

FAQs

1. How does misoprostol compare with other drugs for medical abortion?
   It offers a cost-effective, stable alternative with high efficacy. Mifepristone combined with misoprostol increases success rates but involves patent and regulatory considerations [2].

2. What are the main regulatory hurdles for misoprostol?
   Legal restrictions on abortion use in some countries delay market access. Regulatory approval for postpartum hemorrhage use varies, influencing sales.

3. What is the outlook for competition in the misoprostol market?
   Generics dominate due to patent expiry. New entrants focus on expanding access through partnerships with NGOs and government agencies.

4. Are there concerns related to supply chain stability?
   Yes. Political and legal restrictions, especially in high-regulation markets, can disrupt manufacturing and distribution.

5. What future revenue opportunities exist outside reproductive health?
   Off-label uses such as gastric ulcers decrease as newer therapies emerge, limiting future growth in these segments.

---

Sources

[1] MarketResearch.com. (2023). Global Misoprostol Market Outlook.
[2] WHO. (2019). History and development of medical abortion.