ALPROSTADIL - Generic Drug Details

What are the generic sources for alprostadil and what is the scope of patent protection?

Alprostadil is the generic ingredient in six branded drugs marketed by Hikma, Meitheal, Pfizer, Endo Operations, and Viatris, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for alprostadil. Five suppliers are listed for this compound.

Summary for ALPROSTADIL

US Patents:	0
Tradenames:	6
Applicants:	5
NDAs:	8
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Patent Applications:	6,097
What excipients (inactive ingredients) are in ALPROSTADIL?	ALPROSTADIL excipients list
DailyMed Link:	ALPROSTADIL at DailyMed

Recent Clinical Trials for ALPROSTADIL

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

Sponsor	Phase
Aswan University	PHASE2
Aswan University Hospital	PHASE2
Cairo University	PHASE2

See all ALPROSTADIL clinical trials

Pharmacology for ALPROSTADIL

Drug Class	Prostaglandin Analog Prostaglandin E1 Agonist
Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Genitourinary Arterial Vasodilation Venous Vasodilation

Medical Subject Heading (MeSH) Categories for ALPROSTADIL

Platelet Aggregation Inhibitors

Urological Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for ALPROSTADIL

C01EA	Prostaglandins
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for ALPROSTADIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	EDEX	alprostadil	INJECTABLE;INJECTION	020649-002	Jun 12, 1997	AP	RX	Yes	No
Endo Operations	EDEX	alprostadil	INJECTABLE;INJECTION	020649-003	Jun 12, 1997	AP	RX	Yes	No
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002		RX	No	No
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020755-003	Oct 1, 1997		DISCN	No	No
Hikma	ALPROSTADIL	alprostadil	INJECTABLE;INJECTION	074815-001	Jan 20, 1998	AP	RX	No	No
Endo Operations	EDEX	alprostadil	INJECTABLE;INJECTION	020649-007	Jul 30, 1998		RX	Yes	Yes

Expired US Patents for ALPROSTADIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996	5,242,391
Pfizer	CAVERJECT IMPULSE	alprostadil	INJECTABLE;INJECTION	021212-002	Jun 11, 2002	4,968,299
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	5,886,039
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996	5,886,039
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996	5,474,535
Viatris	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	5,242,391

Market Dynamics and Financial Trajectory for Alprostadil

Last updated: August 17, 2025

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Introduction

Alprostadil, a synthetic prostaglandin E1 analog, has established its role as a critical therapeutic agent within urology and cardiology. It is primarily employed in the management of erectile dysfunction (ED) and certain congenital heart conditions. Over the past decade, its market landscape has experienced significant shifts driven by technological advances, regulatory changes, and evolving consumer preferences. This analysis assesses the current market dynamics and forecasts the financial trajectory of Alprostadil, with implications for stakeholders across pharmaceutical, healthcare, and investment sectors.

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Pharmacological Profile and Clinical Applications

Alprostadil's mechanism involves vasodilation through smooth muscle relaxation, notably affecting penile vasculature and coronary arteries. Its prevalent clinical applications include:

• Erectile Dysfunction: Administered via intracavernosal injection and intraurethral suppositories, Alprostadil addresses ED by eliciting penile erection independent of nitric oxide pathways (as seen with PDE5 inhibitors).

• Critical Congenital Heart Disease (CHD): It is used to maintain ductus arteriosus patency in neonates with various forms of congenital heart defects, serving as a bridge to surgical correction or spontaneous closure.

The versatility and effectiveness of Alprostadil in these indications sustain its demand, though off-label use and alternative therapies influence market share dynamics.

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Market Landscape and Competitive Environment

Global Market Size

The global Alprostadil market was valued at approximately USD 300 million in 2022 (estimates based on industry reports). The erectile dysfunction segment forms the bulk of this, owing to increased recognition and demographic shifts toward aging populations. The neonatal CHD application, albeit smaller in volume, offers high-margin opportunities due to specialized use.

Key Players and Patent Status

Major pharmaceutical firms, including Pfizer, Besins Healthcare, and Ferring Pharmaceuticals, dominate the market. Patent protections for formulations and delivery mechanisms have historically limited generic competition but are nearing expiration in certain regions, prompting a potential increase in generic entrants.

Commercial strategies are transitioning from patent reliance to service-oriented models, including combination therapies and advanced delivery technologies, to preserve margins.

Regulatory Environment

Regulatory agencies such as the FDA and EMA uphold stringent standards for synthetic prostaglandins, impacting drug approval timelines and innovation prospects. Recent approvals for novel delivery devices (e.g., measures to reduce injection-associated discomfort) bolster market expansion.

Additionally, evolving supervised prescription policies influence distribution channels and sales volume, especially in developed economies.

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Market Drivers and Restraints

Drivers

• Aging Population and Rising ED Prevalence: Estimates suggest ED affects approximately 30-40% of men aged 40–70, escalating demand (source: [1]).
• Advancements in Delivery Systems: Innovations in intracavernosal injection techniques and user-friendly formulations improve patient compliance, expanding market reach.
• Global Healthcare Expansion: Increasing healthcare access in emerging markets introduces new customer bases for Alprostadil.

Restraints

• Emergence of Alternative Therapies: PDE5 inhibitors (e.g., sildenafil) dominate ED treatment with oral convenience, reducing Alprostadil's market share.
• Side Effect Profile and Patient Preference: Injection-associated discomfort and adverse effects limit acceptance among certain patients.
• Pricing and Reimbursement Constraints: Cost pressures and insurance coverage variability inhibit widespread adoption, especially in lower-income regions.

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Financial Trajectory and Market Outlook

Short-term Outlook (Next 3–5 Years)

Market growth is expected to slow but remain positive, with an estimated CAGR of 2–3%. Increased penetration in emerging markets, particularly in Asia-Pacific and Latin America, offset stagnating developed-market sales. The entry of generic formulations post-patent expiry could lead to price erosion but also volume increases.

Innovative delivery devices and combination therapies could create niche premium segments, cushioning revenue declines.

Long-term Outlook (Beyond 5 Years)

The long-term trajectory hinges on several factors:

• Regulatory approval for new indications: Potential expansion into other vascular or perfusion-related disorders can open additional revenue streams.
• Technological innovation: Development of less invasive delivery systems and sustained-release formulations can enhance treatment adherence and market penetration.
• Emergence of novel agents: Competing drugs with superior efficacy or safety profiles could diminish Alprostadil's relevance, although its established clinical familiarity sustains its presence.

Overall, the market's compound annual growth rate is projected at approximately 2%, reflecting maturation and competitive challenges.

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Impact of Patent Expiry and Generic Competition

Patent expiries in key markets (e.g., US and EU scheduled around 2024–2026) will catalyze the influx of generics. Historically, such entries suppress prices but increase volumes substantially. Stakeholders aligning with cost-effective manufacturing and strategic partnerships can capitalize on this transition. Early market entry by generic players may erode profit margins but also expand overall market size.

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Geographical Market Dynamics

• North America: Largest market, driven by high ED prevalence, well-established regulatory frameworks, and sophisticated healthcare infrastructure.
• Europe: Mature market with steady demand, yet pricing pressures prevail due to healthcare austerity measures.
• Asia-Pacific & Latin America: High-growth potential due to expanding healthcare access, increased awareness, and rising affluence. Price sensitivity remains a concern but balanced by volume gains.

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Regulatory and Reimbursement Factors

The adoption of Alprostadil is increasingly dependent on reimbursement policies, with favorable coverage influencing prescription rates. Countries implementing universal healthcare or private insurance schemes that favor minimally invasive procedures can bolster sales. Regulatory policies fostering bioequivalence approvals for generics further influence market dynamics.

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Key Challenges and Opportunities

• Challenges: Competitive pressure from oral PDE5 inhibitors, side effect concerns, patent cliff effects, and reimbursement barriers.
• Opportunities: Innovation in delivery technologies, expanding indications, emerging market entry, and rising global healthcare spending.

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Conclusion

Alprostadil’s market landscape is characterized by a mature core dominated by ED and congenital heart disease indications. While patent expiries threaten revenue streams, technological innovations and geographic expansion offer pathways for growth. Strategic positioning, focusing on innovation, cost management, and regulatory navigation, will shape the financial trajectory in the coming years.

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Key Takeaways

• The global Alprostadil market is valued at approximately USD 300 million, with modest growth projections (~2–3% CAGR) over the next five years.
• Patent expiries will open market share for generics, fostering price competition but also volume growth, especially in emerging markets.
• Innovation in drug delivery and expansion into new indications are critical for maintaining competitive advantage.
• The rise of oral PDE5 inhibitors remains a primary competitor, but Alprostadil retains niches where alternatives are less effective or unsuitable.
• Geopolitical and reimbursement policies significantly influence regional market dynamics, necessitating tailored strategies.

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FAQs

1. What are the primary indications for Alprostadil?
Alprostadil is chiefly used to treat erectile dysfunction via intracavernosal injections or intraurethral suppositories and to maintain ductus arteriosus patency in neonates with congenital heart defects.

2. How will patent expiries affect the Alprostadil market?
Patent expiries in key markets will introduce generic alternatives, likely reducing prices but increasing market volume, thus impacting profit margins and strategic positioning for brand-name manufacturers.

3. Are there emerging therapies that threaten Alprostadil’s market share?
Yes; orally administered PDE5 inhibitors like sildenafil dominate ED treatment, reducing reliance on injections and intraurethral applications, especially among patients seeking convenience.

4. Which geographies offer the highest growth potential?
Emerging markets in Asia-Pacific and Latin America present substantial growth opportunities due to expanding healthcare infrastructure and increasing disease awareness.

5. What innovations could expand Alprostadil’s market?
Advancements in less invasive delivery systems, combination therapies, and new indications in vascular medicine can broaden its application and enhance patient compliance.

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References

[1] European Association of Urology Guidelines on Erectile Dysfunction, 2022.