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:	85
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
HaEmek Medical Center, Israel	PHASE4
University Medical Centre Ljubljana	PHASE4
Al-Azhar University	NA

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
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995		RX	Yes	Yes

Expired US Patents for dinoprostone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992
Pfizer	PROSTIN E2	dinoprostone	SUPPOSITORY;VAGINAL	017810-001	Approved Prior to Jan 1, 1982
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995

Market Dynamics and Financial Trajectory for DINOPROSTONE

Last updated: July 31, 2025

Introduction

Dinoprostone, a synthetic prostaglandin E2 (PGE2) analogue, serves primarily as an agent for cervical ripening and labor induction. As a critical component in obstetric care, its market exhibits distinctive characteristics shaped by regulatory landscapes, clinical demand, technological advancements, and competitive forces. This analysis explores the current market dynamics and provides a forecast of the financial trajectory for dinoprostone, emphasizing the factors that influence its growth prospects.

Market Overview

Dinoprostone is marketed under various brand names, including Cervidil and Prepidil, and is utilized predominantly in obstetrics to facilitate labor or terminate pregnancies. The global market for labor induction agents, including dinoprostone, is projected to expand owing to rising maternal age, increased healthcare access, and growing preferences for outpatient obstetric procedures. The market size was valued at approximately USD 300 million in 2022, with an anticipated compound annual growth rate (CAGR) of around 4-6% over the next five years [1].

Market Drivers

Rising Global Birth Rates and Maternal Age

While global fertility rates are declining in some regions, certain emerging markets report increasing maternal ages, which correlates with higher cesarean section rates and labor induction needs. This demographic trend amplifies demand for effective labor induction agents, including dinoprostone.

Advances in Obstetric Technologies

Innovations such as controlled-release delivery systems and combination regimens (e.g., dinoprostone with oxytocin) improve safety and efficacy, expanding market application. These technological advancements foster clinician confidence and expand usage boundaries.

Regulatory Approvals and Off-label Uses

Dinoprostone benefits from proven safety profiles and multiple regulatory approvals (by FDA, EMA), facilitating its market penetration. Off-label applications, such as controlling postpartum hemorrhage, although not universally approved, potentially enlarge the product's scope.

Increasing Awareness and Healthcare Infrastructure

Enhanced healthcare infrastructure, especially in developing countries, facilitates wider distribution and utilization of dinoprostone. Maternal health awareness campaigns further bolster demand.

Market Restraints

Regulatory and Safety Concerns

Due to risks like uterine hyperstimulation and fetal distress, regulatory agencies have imposed stringent guidelines on dinoprostone use. Discontinuation or restriction of certain formulations (e.g., slow-release vaginal inserts) in some jurisdictions constrains market expansion.

Competition from Alternative Agents

The emergence of other labor induction agents, such as misoprostol (off-label but widely used), and mechanical methods (e.g., Foley catheter) challenges dinoprostone's market share. Cost-effectiveness combined with ease of administration makes alternative methods attractive, particularly in resource-limited settings.

Cost and Reimbursement Issues

Pricing strategies and reimbursement policies influence adoption rates. In certain regions, higher costs associated with patented formulations hinder widespread use, favoring generic or off-label options.

Competitive Landscape

Major pharmaceutical companies invest in manufacturing, marketing, and research to consolidate their positions. Key players include Ferring Pharmaceuticals, Merck (EMD Serono), and specialized regional manufacturers. Strategic alliances, patent cliffs, and pipeline developments impact market competitiveness.

Technological and Clinical Innovation Trends

Emerging delivery platforms aim to improve dosing precision and reduce adverse events. For example, bioresorbable vaginal inserts with programmable release profiles are under clinical evaluation, promising to reshape market expectations.

Financial Trajectory and Revenue Forecast

Current Revenue Streams

Existing formulations generate revenues primarily through hospital procurement and outpatient clinics. Patent protections and branding sustain premium pricing, fostering stable income streams.

Projected Growth Trajectory

Given the increasing demand parameters and technology advancements, revenues are projected to grow at a CAGR of 4-6% over the next 5 years. Market expansion is notably driven by:

• Emerging Markets: Rapid healthcare expansion and increasing obstetric intervention rates.
• Regulatory Approvals: Documented safety advantages reinforce product credibility.
• Innovative Delivery Systems: Enhanced safety profiles could command premium pricing and higher adoption rates.

Potential Market Challenges

Generic penetration, off-label alternatives, and regulatory pressures could temper growth. The eventual expiry of patents may reduce prices, contributing to revenue declines unless offset by new formulations or indications.

Regulatory and Policy Impact

Global regulatory trends favor the approval of safer and more efficacious formulations. However, policies targeting maternal health programs can both positively and negatively influence market size, depending on local healthcare priorities and resource allocations.

Conclusion

Dinoprostone's market remains poised for moderate growth driven by demographic shifts, technological innovation, and expanding healthcare infrastructure, primarily in emerging economies. While competition and safety concerns pose challenges, ongoing research and regulatory support are likely to sustain its financial trajectory.

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Key Takeaways

• The dinoprostone market is projected to grow steadily at a CAGR of 4-6% over the next five years, buoyed by demographic and technological factors.
• Innovations in delivery systems and expanding indications are key opportunities for revenue enhancement.
• Price pressures from generics and alternative labor induction methods necessitate strategic differentiation.
• Regulatory scrutiny enhances safety but may limit certain formulations, influencing market dynamics.
• Emerging markets offer significant growth potential, provided infrastructure and awareness continue to improve.

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FAQs

1. How does dinoprostone compare with alternative labor induction agents?
Dinoprostone offers a favorable safety profile with predictable uterine activity, but misoprostol, an off-label alternative, is often preferred in resource-limited settings due to lower cost and ease of oral administration. The choice depends on regional regulatory status, safety considerations, and clinician preference.

2. What technological innovations are shaping dinoprostone formulations?
Progress includes controlled-release vaginal inserts, bioresorbable delivery systems, and combination regimens with oxytocin. These advancements aim to improve safety, efficacy, and patient comfort.

3. How do regulatory changes impact dinoprostone’s market share?
Regulatory agencies’ restrictions on certain formulations or indications can limit market access, while approvals for new delivery methods or indications can expand it. Staying compliant and proactive in clinical evidence generation is critical.

4. What are the key factors influencing dinoprostone pricing?
Pricing is influenced by formulation complexity, patent status, manufacturing costs, competitive landscape, and reimbursement policies. Patented branded products tend to command higher prices, while generics exert downward pressure post-patent expiry.

5. What are the prospects for dynoprostone in emerging markets?
Emerging markets present significant growth opportunities due to expanding healthcare infrastructure, rising maternal health awareness, and increased demand for obstetric interventions. Local manufacturing and regulatory pathways will influence market entry success.

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References

[1] Market Research Future. “Labor Induction Agents Market Analysis, Trends, and Forecast to 2028,” 2022.