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
Pfizer	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617-001	Dec 9, 1992

International Patents for PREPIDIL

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

Country	Patent Number	Title	Estimated Expiration
Finland	81962
Japan	S51112508	COMPOSITION
Germany	3381898
Finland	830890

Market Dynamics and Financial Trajectory for PREPIDIL

Last updated: August 2, 2025

Introduction

Prepidil (generic: alprostadil) is a pharmaceutical product primarily used to treat erectile dysfunction (ED) and to maintain patency of the ductus arteriosus in newborns. Its active ingredient, alprostadil, is a prostaglandin E1 analog that vasodilates blood vessels, enabling its clinical utility across diverse therapeutic areas. Understanding the market dynamics and projected financial trajectory of Prepidil involves assessing its patent landscape, competitive environment, regulatory considerations, and evolving healthcare trends. This analysis provides business professionals with an informed perspective to guide strategic decisions.

Market Landscape and Demand Drivers

Therapeutic Applications and Market Size

Prepidil's foremost indication is functional maintenance of the ductus arteriosus in neonates with congenital heart disease. It also holds significance in ED treatment, particularly as an intracavernosal injection. The demand in neonatal care remains relatively stable, supported by ongoing need for patent ductus arteriosus management in premature infants. Conversely, its role in ED, largely supplanted by oral phosphodiesterase inhibitors (e.g., sildenafil), faces market erosion.

Globally, the neonatal segment represents a niche but critical market, with an estimated annual growth rate of approximately 2-3%. The ED market is larger but increasingly competitive, with Prepidil's usage declining in favor of other delivery methods such as topical or oral formulations.

Pricing and Reimbursement Dynamics

Prepidil commands premium pricing due to its injectable formulation and specific indications. However, reimbursement policies vary across regions, affecting accessibility and profitability. In developed markets such as the US and EU, insurers often favor less invasive, oral alternatives, constraining revenue potential for injectable Prepidil.

Competitive Landscape

The primary competitors include other prostaglandin-based agents, as well as newer therapies for specific indications. For neonatal use, alternatives are limited but include other forms of prostaglandins like iloprost, though none have overtaken Prepidil in this niche. In ED, drugs like Viagra, Cialis, and topical formulations dominate, reducing Prepidil’s market share.

The patent status of Prepidil suggests near or complete expiration, opening avenues for generic competition. Generic alprostadil products are accessible in various markets, further reducing pricing power.

Regulatory Environment and Patent Status

Regulatory Approval and Limitations

Prepidil has received regulatory approval in multiple regions for neonatal indications but faces limited expanded indications due to safety and efficacy concerns. The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulate its utilization, with strict guidelines on dosing and application.

Patent and Market Exclusivity Timeline

The original patents for Prepidil have expired or are close to expiration, opening the market to generic manufacturers. This transition marks a significant shift towards commoditization, pressuring revenues and margins for the incumbent producer. Companies must innovate or reposition their offerings to maintain revenue streams.

Market Challenges and Opportunities

Challenges

1. Generic Competition: Rapid entry of generics will substantially reduce market prices and margins.
2. Limited Indication Expansion: Regulatory hurdles and safety concerns hinder approval for new indications.
3. Market Shifts: Preference for non-injectable treatments and oral medications diminishes the demand for injectable Prepidil.
4. Pricing Pressure: Payers’ focus on cost-effective alternatives constrains premium pricing.

Opportunities

1. Niche Market Focus: Maintaining a foothold in neonatal cardiology by optimizing use protocols.
2. Formulation Innovations: Developing sustained-release or less invasive formulations to enhance patient compliance.
3. Strategic Partnerships: Collaborations with biotech firms to expand indications or improve delivery methods.
4. Market Penetration in Emerging Economies: Growing healthcare infrastructure may increase adoption where affordability is managed through local manufacturing.

Financial Trajectory and Prognosis

Revenue Outlook

In the short term, revenues are expected to decline as patent expiries lead to generic erosion. Established manufacturers might face 30-50% annual revenue decline in neonatal indications over the next 3-5 years if no new markets or formulations are introduced.

Profitability Trends

Margins for Prepidil are likely to compress due to intense price competition among generics, with potential for pricing erosion exceeding 60%. Companies with diversified portfolios or with strategic innovations may offset declining revenues.

Long-term Outlook

The long-term financial trajectory hinges on repositioning strategies. The neonatal segment remains stable but limited in growth, while the decreasing ED relevance and patent expirations point toward a downtrend unless product differentiation or new indications are achieved.

Emerging Trends and Strategic Considerations

• Biopharmaceutical Innovation: Advances in drug delivery, such as nanoparticle formulations, could revitalize Prepidil’s market potential.
• Regulatory Reforms: Streamlined pathways for pediatric indications may open new opportunities.
• Market Diversification: Entry into regions with limited existing treatments or developing markets could provide incremental revenue.

Conclusion

Prepidil’s market dynamics are characterized by impending generic competition and a shrinking revenue base driven by alternative therapies and evolving clinical preferences. While neonatal application remains a critical niche, the overall financial trajectory is downward absent strategic repositioning. Companies should focus on innovation, lifecycle management, and geographic diversification to sustain profitability.

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Key Takeaways

• Patent expirations are exposing Prepidil to intense generic competition, significantly impacting profitability.
• Growth opportunities are primarily confined to niche neonatal markets; broader indications face regulatory and safety hurdles.
• The shift toward less invasive and oral therapies diminishes demand for injectable alprostadil.
• Strategic innovations in drug delivery and exploration of emerging markets are vital for maintaining revenue streams.
• Long-term success depends on lifecycle management, including formulation improvements and potential repurposing.

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FAQs

1. What are the primary drivers of demand for Prepidil?
   The neonatal management of patent ductus arteriosus remains the key driver, with demand driven by congenital heart disease prevalence and neonatal care standards.

2. How will patent expiries affect Prepidil's market share?
   Patent expiries facilitate generic entry, leading to significant price reductions and a projected decline in market share for the brand-name product.

3. Are there ongoing efforts to expand Prepidil’s indications?
   Attempts for indication expansion are limited due to regulatory challenges and safety concerns, especially in adult ED treatment.

4. What strategies can companies employ to counteract declining revenues?
   Innovating formulations, seeking new indications, entering emerging markets, and developing combination therapies are tactical options.

5. How significant is the role of regional healthcare policies in shaping Prepidil’s market?
   Reimbursement policies and regulatory approval processes vary regionally, influencing product accessibility and profitability significantly.

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References

[1] Market analysis reports on neonatal therapeutics and ED drugs.
[2] Regulatory agencies' approval and patent status disclosures.
[3] Industry reports on generic drug market penetration and patent cliff impacts.