CYTOTEC Drug Patent Profile

Which patents cover Cytotec, and what generic alternatives are available?

Cytotec is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in CYTOTEC is misoprostol. There are fourteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the misoprostol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cytotec

A generic version of CYTOTEC was approved as misoprostol by ANI PHARMS on July 10^th, 2002.

Summary for CYTOTEC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	106
Patent Applications:	6,777
Drug Prices:	Drug price information for CYTOTEC
What excipients (inactive ingredients) are in CYTOTEC?	CYTOTEC excipients list
DailyMed Link:	CYTOTEC at DailyMed

See drug prices for CYTOTEC

Recent Clinical Trials for CYTOTEC

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

Sponsor	Phase
Stanford University	Phase 3
Cairo University	N/A
University of Texas at Austin	Phase 4

See all CYTOTEC clinical trials

Pharmacology for CYTOTEC

Drug Class

Prostaglandin E1 Analog

US Patents and Regulatory Information for CYTOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990	AB	RX	Yes	No
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988	AB	RX	Yes	Yes

Expired US Patents for CYTOTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-003	Sep 21, 1990
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988
Pfizer	CYTOTEC	misoprostol	TABLET;ORAL	019268-001	Dec 27, 1988

International Patents for CYTOTEC

See the table below for patents covering CYTOTEC around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	63747
Finland	750899
Japan	S50135059
Egypt	12063	PROCESS FOR PREPARING OF 16-OXYGENATED PHOSPHANOIC ACID DERIVATIVES
European Patent Office	0129908	USE OF MISOPROSTOL TO MANUFACTURE CHOLESTEROL LOWERING MEDICINES

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CYTOTEC

Last updated: July 29, 2025

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Introduction

CYTOTEC, the brand name for misoprostol, is a medication originally developed as a gastroprotective agent. Over time, its therapeutic applications have expanded, positioning it within reproductive health, obstetrics, and gynecology markets. Understanding its market dynamics and financial trajectory involves analyzing regulatory landscapes, emerging therapeutic uses, patent statuses, competition, and geopolitical factors influencing supply and demand.

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Historical Context and Product Profile

Misoprostol was first approved in the 1980s to prevent gastrointestinal ulcers caused by long-term NSAID use. Its mechanism of action involves prostaglandin E1 analog activity, which induces uterine contractions and cervical ripening—leading to applications in pregnancy termination and labor induction. The drug's off-label use in multiple jurisdictions has significantly influenced its demand.

Notably, CYTOTEC’s primary approved indications are domestically confined; however, off-label and patent-protected uses, particularly medical termination of pregnancy, have been central to its commercial landscape, especially in markets where alternative products are limited.

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Market Dynamics Analysis

Regulatory Environment

The regulatory climate profoundly influences CYTOTEC’s market trajectory. In several countries, misoprostol’s off-label status for pregnancy termination has led to legal and ethical challenges. For instance, in the United States, misoprostol is FDA-approved solely for gastrointestinal indications, while medical abortion is typically facilitated with mifepristone and misoprostol under approved protocols employing off-label use.

Conversely, in countries like China and some Latin American nations, regulation of misoprostol remains lax or aligns with evolving reproductive rights, expanding market access.

Recent regulatory shifts—owing to the global decriminalization of abortion and increased acceptance of medical termination—have expanded the scope for pharmaceutical companies to promote misoprostol for reproductive health, fueling increased sales.

Patent and Intellectual Property Landscape

Patent statuses significantly impact CYTOTEC’s economic potential. Originally patented in the 1980s, the drug expired in numerous jurisdictions by the late 2000s, opening a generic floodgate. Generics substantially reduced prices, affecting revenue streams for original manufacturers like Pfizer.

In recent years, companies have pursued secondary patents surrounding specific formulations or delivery mechanisms to extend exclusivity. Litigation and patent challenges continue to shape the landscape, influencing the availability and pricing of CYTOTEC-related products.

Competitive Environment

The entry of generic suppliers following patent expiry has intensified price competition. Key competitors include local generic manufacturers across emerging markets. The proliferation of low-cost generics has constrained profit margins for brand-name versions.

However, branded variants with specific delivery systems or combination products may command premium pricing, especially in regions with regulated markets for reproductive health.

Evolving Therapeutic Uses

Beyond its established indications, emergent research explores misoprostol's efficacy in postpartum hemorrhage management, cervical ripening, and labor induction, especially in low-resource settings. WHO’s endorsement of misoprostol for obstetric care has expanded its global footprint.

This expanded therapeutic portfolio diversifies market demand but introduces regulatory and safety considerations, which influence commercial strategies and forecasting.

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Financial Trajectory & Market Forecast

Historical Revenue Trends

Historically, CYTOTEC experienced peak revenues in the early 2000s amid high demand for reproductive health applications. Following patent expiration and generic entry, revenues declined markedly in developed markets but remained stable or grew modestly in emerging regions where regulatory restrictions or procurement practices support continued use.

Current Market Size and Forecast

Globally, the misoprostol market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4-6% over the next five years, driven primarily by increased acceptance in obstetric care and expanding access in low- and middle-income countries (LMICs).

Emerging markets, including India, Africa, and Southeast Asia, present substantial growth opportunities due to unmet reproductive health needs, government procurement programs, and international aid organizations promoting safe abortion methods.

In developed nations, growth is primarily tied to reintroduction or expanded indication approval, with potential revenue stabilization through combination products or improved formulations.

Factors Impacting Future Revenue

• Regulatory Approvals: Broader approval for obstetric and gynecological uses can catalyze revenue growth.
• Patent Strategies: Patent extensions or new formulations could prolong exclusivity, maintaining higher prices.
• Global Health Initiatives: WHO and NGOs’ endorsement boost adoption, attracting funding and procurement budgets.
• Legal and Ethical Climate: Changes in abortion laws influence demand, especially in high-income countries.
• Competitive Pricing: Generic competition dictates price points, impacting margins.

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Key Risks & Opportunities

Risks:

• Legal and Regulatory Barriers: Stringent restrictions in certain markets can stifle sales.
• Intellectual Property Litigation: Patent challenges threaten exclusivity.
• Market Saturation: Generics flood markets, compressing margins.
• Safety Concerns: Adverse events may induce regulatory scrutiny and public apprehension.

Opportunities:

• Expanded Indications: Research into additional therapeutic applications can unlock new revenue streams.
• Global Health Policies: Integration into maternal mortality reduction programs enhances demand.
• Formulation Innovations: Development of user-friendly delivery mechanisms, such as fixed-dose combinations, can command premium pricing.
• Market Penetration in LMICs: Supporting programs targeting reproductive health can facilitate volume growth.

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Conclusion

The financial trajectory of CYTOTEC hinges on regulatory developments, patent strategies, emergent therapeutic applications, and geopolitical policies. While challenges persist, especially from generics and regulatory barriers, global health initiatives and evolving medical guidelines present substantial avenues for sustained growth. Strategic focus on expanding indications, optimizing formulations, and navigating legal landscapes will be imperative for stakeholders aiming to harness its full market potential.

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Key Takeaways

• Global Expansion: The increasing acceptance of misoprostol in reproductive health, especially in LMICs, promises continued demand growth.
• Patent and Regulatory Strategies: Extending exclusivity through innovation and navigating regulatory approvals are critical for revenue stability.
• Competitive Landscape: A market characterized by intense generic competition requires differentiated offerings or value-added formulations to maintain margins.
• Therapeutic Diversification: Research into new indications enhances long-term prospects, especially in obstetric care.
• Policy Impact: Legal and policy shifts regarding reproductive rights directly influence demand, necessitating adaptive market strategies.

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FAQs

1. What are the primary therapeutic uses of CYTOTEC?
   Originally approved for preventing NSAID-induced gastric ulcers, CYTOTEC is extensively used off-label for pregnancy termination, cervical ripening, and labor induction globally.

2. How has patent expiration affected CYTOTEC's market?
   Patent expiry led to widespread generic availability, significantly reducing prices and market share for the original branded drug but opening new market segments through lower-cost alternatives.

3. Which regions represent the highest growth opportunities for CYTOTEC?
   Low- and middle-income countries in Africa, Southeast Asia, and Latin America offer the most promising growth prospects, driven by increasing access to reproductive health services and international aid initiatives.

4. What challenges does CYTOTEC face in maintaining its market share?
   Challenges include legal restrictions on abortion in some countries, regulatory hurdles, competition from generics, and safety concerns associated with off-label use.

5. What is the future outlook for CYTOTEC’s revenues?
   With expanding indications and global health policy support, revenues are expected to grow modestly, particularly in underserved markets, despite ongoing generic competition.

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References

1. World Health Organization. Guidelines for sexual and reproductive health. 2021.
2. U.S. Food and Drug Administration. Misoprostol information. 2022.
3. MarketWatch. Global misoprostol market size and forecast. 2023.
4. Johnson, L. et al. Global health policies impacting reproductive medicine. Reproductive Health Journal, 2022.
5. Patent and Trademark Office Records. Misoprostol patent history. 2023.