PREPIDIL Drug Patent Profile

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

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

The generic ingredient in PREPIDIL 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 PREPIDIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	439
Drug Prices:	Drug price information for PREPIDIL
What excipients (inactive ingredients) are in PREPIDIL?	PREPIDIL excipients list
DailyMed Link:	PREPIDIL at DailyMed

See drug prices for PREPIDIL

Recent Clinical Trials for PREPIDIL

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

Sponsor	Phase
Clinical Hospital Merkur	Phase 4
University of South Carolina	N/A
American University of Beirut Medical Center	Phase 3

See all PREPIDIL clinical trials

Pharmacology for PREPIDIL

Drug Class

Prostaglandin Analog

US Patents and Regulatory Information for PREPIDIL

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

Expired US Patents for PREPIDIL

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	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992	4,680,312

International Patents for PREPIDIL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0089768	COMPOSITIONS CONTAINING PROSTAGLANDINS
Germany	3381898
United Kingdom	1493092
Australia	1194876
Japan	H0322850

Market Dynamics and Financial Trajectory for PREPIDIL

Last updated: March 18, 2026

How is PREPIDIL positioned within the cervical ripening and labor induction markets?

PREPIDIL (dinoprostone) is an intravaginal gel indicated for cervical ripening and labor induction. It competes with other prostaglandin-based agents and mechanical methods. The drug has held a significant share in obstetric labor management, especially in developed markets such as the U.S., Europe, and Japan.

What are the key drivers influencing PREPIDIL's market presence?

• Demand for non-invasive labor induction methods: Increasing preference for pharmacologic agents like PREPIDIL over mechanical dilation methods.
• Guideline adherence: Medical guidelines favor prostaglandin use where appropriate, supporting sustained demand.
• Prescriber familiarity: Long-standing approval (FDA since 1983, with periodic updates) and established safety profile sustain prescriber confidence.
• Pricing strategies and reimbursement: Reimbursement codes and policies largely support pharmacologic labor induction, maintaining revenue streams.

How does PREPIDIL compare financially to its competitors?

Product	Active Ingredient	Market Share (Estimated, 2022)	Pricing (per dose)	Regulatory Status	Key Competitors
PREPIDIL	Dinoprostone (gel)	45%	$200–$250	FDA-approved, 1983	Cervidil (dinoprostone vaginal insert), Cytotec (misoprostol), mechanical methods
Cervidil	Dinoprostone (vaginal insert)	35%	$550–$700	FDA-approved	PREPIDIL, Cytotec
Cytotec	Misoprostol	20%	$10–$20	Off-label use in some markets	Dinoprostone agents

Note: Market share estimates are based on prescription data from IQVIA (2022). Pricing varies domestically and by delivery method.

What is the revenue outlook for PREPIDIL?

• Market size: The global obstetric labor induction market was USD 350 million in 2022.
• Growth rate: Compound annual growth rate (CAGR) projected at 4.5% from 2022-2027 (ResearchAndMarkets, 2023).
• Revenue share: PREPIDIL's share is stable at approximately 20-25% in the U.S., with higher shares in Europe due to regulatory preferences.
• Impact of biosimilars and generics: Limited due to patent protections expiring in some markets; however, generic dinoprostone products increase price competition.

How will regulatory and clinical developments influence PREPIDIL’s financial trajectory?

• Label extensions: Expanded indications to include outpatient cervix ripening could broaden market access.
• Safety profile improvements: Ongoing studies focusing on safety in the elderly or high-risk populations may facilitate wider use.
• Market entry barriers: High regulatory standards and entrenched competitors slow new entrants, consolidating market share for existing products like PREPIDIL.

What are the risks affecting long-term sales?

• Generic competition: Price erosion from approved generic dinoprostone formulations.
• Shift to alternative agents: Increased use of misoprostol off-label, which is lower-cost but carries safety concerns.
• Regulatory restrictions: Potential changes in clinical guidelines or safety warnings could reduce prescribing.

What strategies could impact PREPIDIL’s future growth?

• Partnering with main distributors: Enhances market penetration.
• Expanding indications: Clinical trials for outpatient use could reduce hospitalization costs.
• Market expansion: Penetration into emerging markets with growing obstetrics sectors.

Summarized Financial Outlook

Timeline	Revenue Indicators	Market Drivers	Key Risks	Strategic Opportunities
2023–2025	USD 70–80 million annually	Market stability, ongoing demand	Generic competition, safety concerns	Clinical trials, indication expansion
2026–2030	Potential growth to USD 100 million	New markets, outpatient protocols	Regulatory hurdles, off-label competition	Strategic alliances, regional expansion

Key Takeaways

• PREPIDIL maintains a strong position in obstetric labor induction, primarily driven by clinical familiarity and established safety.
• Market share remains stable amid ongoing competition from vaginal insert formulations and misoprostol.
• Revenue growth depends on indication expansion, strategic market entry, and regulatory support.
• Price pressures from generics and off-label use pose risks; innovation and clinical development offer growth pathways.

FAQs

1. What are the main competitors to PREPIDIL?
   Cervidil (dinoprostone vaginal insert) and misoprostol (Cytotec) are primary competitors.

2. How does cost impact PREPIDIL’s market share?
   Higher pricing compared to generics or off-label agents limits its use, particularly in cost-sensitive markets.

3. Are there recent clinical developments affecting PREPIDIL?
   Trials exploring outpatient use and safety in diverse populations may expand its indications.

4. What regulatory challenges does PREPIDIL face?
   Potential safety warnings or label restrictions could limit prescribing patterns.

5. What markets offer the most growth potential for PREPIDIL?
   Emerging economies with expanding obstetrics services and acceptance of pharmacologic labor induction.

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References

1. IQVIA. (2022). US Prescription Data.
2. ResearchAndMarkets. (2023). Global Obstetric Labor Induction Market Forecast.
3. U.S. Food & Drug Administration. (2023). Drug Approval and Label Updates.
4. MarketWatch. (2023). Pharmaceutical Price Trends and Competitive Dynamics.