Dinoprostone - Generic Drug Details

What are the generic sources for dinoprostone and what is the scope of freedom to operate?

Dinoprostone is the generic ingredient in three branded drugs marketed by Pfizer and Ferring Pharms Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for dinoprostone. Two suppliers are listed for this compound.

Summary for dinoprostone

US Patents:	0
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	86
What excipients (inactive ingredients) are in dinoprostone?	dinoprostone excipients list
DailyMed Link:	dinoprostone at DailyMed

Recent Clinical Trials for dinoprostone

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

Sponsor	Phase
National Hospital of Obstetrics and Gynecology	NA
HaEmek Medical Center, Israel	PHASE4
University Medical Centre Ljubljana	PHASE4

See all dinoprostone clinical trials

Pharmacology for dinoprostone

Drug Class

Prostaglandin Analog

Medical Subject Heading (MeSH) Categories for dinoprostone

Oxytocics

Anatomical Therapeutic Chemical (ATC) Classes for dinoprostone

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

US Patents and Regulatory Information for dinoprostone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992		RX	Yes	Yes
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995		RX	Yes	Yes
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for dinoprostone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992	3,966,962
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982	3,899,587
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992	4,680,312
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982	3,598,858
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995	5,269,321
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995	4,931,288

Market Dynamics and Financial Trajectory for Dinoprostone

Last updated: February 19, 2026

Dinoprostone, a prostaglandin E2 analog, is used primarily for cervical ripening and labor induction. Its market landscape involves established and emerging regions, regulatory factors, and competitive dynamics influencing its financial trajectory.

Market Size and Growth Drivers

The global market for labor induction agents, including dinoprostone, was valued at approximately USD 800 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030, driven by rising birth rates, increased maternal age, and preference for medical labor induction.

Key Growth Factors:

• Demographic shifts: Aging maternal populations in North America and Europe increase demand.
• Institutional preferences: Preference for pharmacological methods over mechanical ones for cervical ripening.
• Regulatory approvals: Clearances for new formulations and indications expand market reach.

Regional Market Dynamics

Region	Market Share (2022)	Growth Outlook	Regulatory Status	Key Players
North America	45%	6-7% CAGR	FDA approved; advanced clinical use	Pfizer, Covis Pharma
Europe	25%	6-8% CAGR	EMA approved; growing acceptance	MSD, Laboratori Almirall
Asia-Pacific	15%	7-9% CAGR	Increasing approvals; affordability concerns	Ferring, local biotech
Latin America	10%	5-6% CAGR	Regulatory pathways evolving	Local suppliers

Market Competition

The market features a few dominant players:

• Pfizer: Market leader with Prepidil and Prostin E2.
• Covis Pharma: Commercializes Cervidil, a controlled-release dinoprostone insert.
• Laboratorios Almirall: Regional presence in Europe with licensed formulations.

New entrants focus on biosimilar or innovative delivery systems, such as controlled-release and sustained-release formulations, to differentiate.

Regulatory Landscape

Dinoprostone formulations are approved variably across regions:

• US: FDA-approved, with designated routes for cervical ripening (Prepidil) and labor induction (Cervidil).
• Europe: EMA approval for similar indications; regulatory updates facilitate broader access.
• Asia-Pacific and Latin America: Emerging approvals; regulatory bodies increasingly accept standard protocols.

Pricing and Reimbursement

Pricing varies by region, influenced by healthcare policies:

• North America: USD 150–USD 250 per dose.
• Europe: EUR 120–EUR 200 per application.
• Asia-Pacific: Lower, around USD 50–USD 100 per dose due to market sensitivity.

Reimbursement policies favor hospital procurement, impacting sales volume and revenue recognition.

R&D and Pipeline Outlook

Current R&D efforts focus on:

• Delivery innovations: Development of sustained-release devices to improve efficacy and compliance.
• New indications: Exploring uses for miscarriage management and other gynecological conditions.
• Combination therapies: Studies on combining dinoprostone with other agents for optimized labor induction.

Biopharmaceutical companies investing in these areas could influence future pricing structures and market size.

Financial Trajectory

Year	Estimated Market Size (USD millions)	Compound Growth Rate	Comments
2023	880	—	Base year; steady growth driven by existing demand
2025	1,000–1,100	6-8%	Increased adoption in emerging regions, new formulations
2030	1,400–1,600	6-8%	Market expansion, pipeline product launches

Though mature in North America and Europe, growth in Asia-Pacific and Latin America propels the longer-term forecast.

Risk Factors and Challenges

• Regulatory delays: Slower approvals or restrictions may limit market expansion.
• Pricing pressures: Cost containment policies in healthcare systems could constrain revenue.
• Competition from alternatives: Mechanical methods and newer drugs could cannibalize dinoprostone's market share.

Key Takeaways

• The dinoprostone market is projected to expand with a CAGR of approximately 6-8% through 2030.
• North America and Europe dominate current sales but growth is driven increasingly by Asia-Pacific.
• Regulatory frameworks generally support growth, with ongoing innovations in delivery systems.
• Pricing volatility and competitive alternatives remain market risks.
• R&D focusing on sustained-release delivery systems and expanded indications could influence future revenues.

FAQs

Q1. What is the primary use of dinoprostone?
It is used for cervical ripening and labor induction in obstetric care.

Q2. How do regulatory differences affect dinoprostone markets?
Regulatory approval status influences market access, pricing, and formulation availability across regions.

Q3. What competitive strategies do companies adopt?
Developing improved delivery systems, expanding indications, and obtaining regulatory approvals in emerging markets.

Q4. What factors influence pricing in different regions?
Healthcare reimbursement policies, market competition, and manufacturing costs.

Q5. How might R&D developments impact the market?
Innovations in sustained-release formulations and new indications could expand market size and extend product lifecycle.

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References

[1] MarketsandMarkets. (2023). Labor Induction Drugs Market.
[2] WHO. (2022). Maternal and Newborn Health Data.
[3] European Medicines Agency. (2023). Pharmacovigilance and Approvals.
[4] US Food and Drug Administration. (2022). Dinoprostone (Cervidil, Prepidil) Approval.
[5] Grand View Research. (2023). Labor Induction Agents Market Size, Share & Trends.