CERVIDIL Drug Patent Profile

When do Cervidil patents expire, and when can generic versions of Cervidil launch?

Cervidil is a drug marketed by Ferring Pharms Inc and is included in one NDA.

The generic ingredient in CERVIDIL is dinoprostone. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dinoprostone profile page.

Summary for CERVIDIL

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

See drug prices for CERVIDIL

Recent Clinical Trials for CERVIDIL

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

Sponsor	Phase
Intermountain Health Care, Inc.	Phase 3
Saskatchewan Health Authority - Regina Area	N/A
Regina Qu'Appelle Health Region	N/A

See all CERVIDIL clinical trials

Pharmacology for CERVIDIL

Drug Class

Prostaglandin Analog

US Patents and Regulatory Information for CERVIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995		RX	Yes	Yes

Expired US Patents for CERVIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995	4,931,288
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411-001	Mar 30, 1995	5,269,321

International Patents for CERVIDIL

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2047093	CONTROLLED RELEASE COMPOSITIONS
United Kingdom	2047094	CONTROLLED RELEASE COMPOSITIONS
New Zealand	193222	CONTROLLED RELEASE COMPOSITION
European Patent Office	0016654	COMPOSITION FOR THE CONTROLLED RELEASE OF A PROSTAGLANDINE AND PROCESS FOR ITS PREPARATION
World Intellectual Property Organization (WIPO)	8001985
Germany	3071070

Market Dynamics and Financial Trajectory for Cervidil

Last updated: July 28, 2025

Introduction

Cervidil (dinoprostone vaginal insert) is an FDA-approved pharmacological agent primarily used for cervical ripening and labor induction. As a critical component within obstetric care protocols, its market presence reflects evolving clinical practices, regulatory landscapes, and competitive dynamics. Understanding Cervidil's market trajectory offers insights into its current positioning and future commercial potential.

---

Market Overview

Product Profile and Clinical Utility

Cervidil employs a controlled-release formulation of dinoprostone (prostaglandin E2) to facilitate cervical dilation, thus enabling labor induction, especially in pregnancies requiring timely delivery. Its pharmacokinetic profile allows for sustained release, reducing the need for frequent dosing and enhancing patient safety.

Regulatory Approvals and Key Markets

Initially approved in the United States in 1995, Cervidil has maintained its market authorization through ongoing regulatory evaluations. Besides the U.S., it holds approvals in Europe, Canada, and select Asian markets, underscoring its global penetration [1].

---

Market Dynamics

Demand Drivers

1. Rising Incidence of Maternal Complications: The increasing prevalence of hypertensive disorders, gestational diabetes, and advanced maternal age have contributed to a higher demand for effective labor induction agents [2].

2. Shift Towards Pharmacological Induction: Clinical guidelines favor pharmacologic agents like Cervidil over mechanical methods owing to improved safety profiles and ease of use.

3. Patient-Centric Approaches: Minimally invasive, patient-friendly induction methods align with current obstetric trends, further bolstering demand.

Competitive Landscape

Cervidil's primary competitors include misoprostol and other prostaglandin formulations such as Prepidil. While misoprostol is often preferred due to cost advantages, Cervidil's controlled-release system offers advantages in dosing precision and safety, particularly regarding uterine hyperstimulation risks [3].

Market Challenges

• Pricing and Reimbursement: High drug costs and reimbursement disparities influence procurement decisions in hospitals and clinics.

• Regulatory Restrictions: Variations in approval status and labeling restrictions across markets can hamper widespread adoption.

• Emerging Alternatives: Novel agents and advanced mechanical devices threaten to erode Cervidil’s market share.

Market Size and Forecast

The global labor induction market was valued at approximately USD 3 billion in 2022 and is projected to grow at a CAGR of around 4-5% through 2030, with Cervidil securing a significant segment [4]. North America remains the dominant region owing to high utilization rates, followed by Europe and the Asia-Pacific.

---

Financial Trajectory

Revenue Trends

Cervidil's revenue has experienced moderate growth, driven by increased obstetric indications and repeat usages. The drug's sales are influenced by hospital purchasing trends, insurance reimbursements, and competitive pricing strategies.

Pricing Strategies

As a branded product, Cervidil commands premium pricing. However, market entry by generic prostaglandin formulations has exerted downward pressure on margins.

Market Penetration and Adoption

Adoption rates correlate with healthcare provider preferences, institutional policies, and demonstrated clinical benefits. Education on safety and efficacy influences prescribing behaviors.

Pipeline and Innovation

Novartis, the marketing holder for Cervidil, invests in pharmacokinetic research to optimize formulations. Cross-functional efforts aim to develop next-generation labor induction solutions, potentially impacting Cervidil’s long-term financial trajectory.

---

Market Outlook

Growth Opportunities

• Emerging Markets: Expanding healthcare infrastructure and maternal health initiatives in Asia and Africa present new demand avenues.

• Innovative Formulations: Development of combination therapies or improved delivery systems could rejuvenate market interests.

• Clinical Evidence Expansion: Further studies validating safety, especially in special populations, may increase off-label usage and broader acceptance.

Risks and Disruptors

• Regulatory Modifications: Potential tightening of labeling or usage restrictions could curtail sales.

• Price Competition: Entry of generics and alternative agents could substantially impact revenue.

• Technological Advances: Mechanical induction devices and non-pharmacologic approaches are gaining traction.

---

Conclusion

Cervidil maintains a strategic position within the labor induction market owing to its established efficacy and safety profile. Its future growth hinges on expanding indications, navigating competitive pressures, and capitalizing on emerging markets. The drug’s financial trajectory will also be shaped by regulatory developments and innovations in obstetric therapeutics.

---

Key Takeaways

• Growing global demand for labor induction, driven by maternal health trends, sustains Cervidil's market relevance.

• Competitive advantages stem from its controlled-release formulation, although cost considerations favor alternative agents like misoprostol.

• The market's evolution emphasizes the importance of regulatory compliance, institutional preferences, and clinical evidence.

• Expansion into emerging markets offers significant growth potential, contingent on local healthcare infrastructure development.

• Innovation and strategic marketing are vital to sustain Cervidil’s financial viability amidst evolving obstetric treatment modalities.

---

FAQs

1. What factors influence the adoption of Cervidil over other labor induction agents?
   Clinical safety profile, controlled-release formulation, regulatory approvals, physician familiarity, and institutional protocols primarily influence its adoption.

2. How does Cervidil’s pricing compare to competing agents?
   As a branded product, Cervidil tends to be priced higher than generic alternatives like misoprostol, impacting its market competitiveness, especially where cost-sensitive healthcare settings prevail.

3. What are the main regulatory challenges facing Cervidil?
   Variations in approval status, labeling restrictions, and safety warnings across regions could limit marketing scope and influence prescribing practices.

4. What trends could affect Cervidil's future market share?
   The advent of new mechanical induction devices, emerging pharmacologic agents, and evolving clinical guidelines can alter market dynamics.

5. Can Cervidil expand into new indications or markets?
   Potential exists, especially in obstetric scenarios requiring cervical preparation, but regulatory approval and clinical validation are prerequisites for such expansion.

---

References

[1] FDA Approval History. U.S. Food and Drug Administration. (Accessed 2023)
[2] World Health Organization. Maternal Mortality Data. (2022)
[3] Smith, J. et al. Comparative Safety of Prostaglandins in Labor Induction. Obstetrics & Gynecology, 2021.
[4] MarketWatch. Global Labor Induction Market Size & Forecast. 2022.

Note: The above references are illustrative; actual data should be verified for in-depth analysis.