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Last Updated: December 16, 2025

ALFENTANIL Drug Patent Profile


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When do Alfentanil patents expire, and what generic alternatives are available?

Alfentanil is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in ALFENTANIL is alfentanil hydrochloride. There are two drug master file entries for this compound. Additional details are available on the alfentanil hydrochloride profile page.

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Summary for ALFENTANIL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 55
Patent Applications: 6,613
Drug Prices: Drug price information for ALFENTANIL
What excipients (inactive ingredients) are in ALFENTANIL?ALFENTANIL excipients list
DailyMed Link:ALFENTANIL at DailyMed
Drug patent expirations by year for ALFENTANIL
Drug Prices for ALFENTANIL

See drug prices for ALFENTANIL

Recent Clinical Trials for ALFENTANIL

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

SponsorPhase
Chi Kwan FungNA
WeiGong Memorial HospitalNA
National Yang Ming Chiao Tung UniversityNA

See all ALFENTANIL clinical trials

US Patents and Regulatory Information for ALFENTANIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira ALFENTANIL alfentanil hydrochloride INJECTABLE;INJECTION 075221-001 Oct 28, 1999 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Alfentanil: An In-Depth Analysis

Last updated: July 28, 2025


Introduction

Alfentanil, a potent synthetic opioid analgesic, plays a significant role in anesthesia and pain management. Developed in the 1980s, its rapid onset and short duration make it a preferred choice in surgical settings. As the healthcare landscape evolves, understanding the market dynamics and financial trajectory of alfentanil is crucial for stakeholders across pharmaceuticalmanufacturers, healthcare providers, and investors. This comprehensive analysis explores the factors shaping the market environment, revenue streams, drivers, constraints, and future forecasts associated with alfentanil.


Pharmacological Profile and Clinical Applications

Alfentanil belongs to the class of opioids, acting as a potent μ-opioid receptor agonist. Its pharmacokinetic properties include rapid onset (within 1-2 minutes), short duration (about 15-30 minutes), and high potency (approximately 1/10th of fentanyl), which facilitate its use during procedures requiring deep analgesia with minimal respiratory depression [1].

In clinical practice, alfentanil is chiefly employed during anesthesia induction, sedation in intensive care units (ICUs), and in certain pain management protocols. Its controllable pharmacodynamic profile favors its use in outpatient surgeries and monitored anesthesia care (MAC).


Market Dynamics

1. Demand Factors

  • Growing Surgical Volume: The global increase in outpatient surgeries and minimally invasive procedures directly boosts dhalfentanil utilization. The rise in elective surgeries, driven by aging populations and technological advancements, expands the market footprint.

  • Shift Towards Opioid-Based Anesthesia: Despite concerns over opioid misuse, opioids remain integral in anesthesia protocols due to their efficacy. Alfentanil's quick recovery profile makes it attractive for fast-tracked surgeries, confirming steady demand.

  • Emerging Trend in ICU Sedation: The adoption of alfentanil for ICU sedation, especially in ventilator-dependent patients, further supports consumption, particularly in regions with advanced healthcare infrastructure.

2. Supply Chain and Manufacturing Landscape

Manufacturing is dominated by a handful of pharmaceutical companies with proprietary synthesis processes. The complexity of opioid manufacturing and regulatory constraints pose barriers for new entrants, limiting market competition [2].

3. Regulatory Environment

  • Stringent Regulatory Oversight: Agencies such as the U.S. FDA and EMA impose strict controls on opioid manufacturing, distribution, and reporting. These regulations influence production costs and accessibility.

  • Opioid Crisis Impact: Heightened awareness of opioid misuse has prompted tighter controls globally, affecting legitimate medical use and supply chains.

4. Competitive Landscape

While alfentanil faces competition from other opioids like fentanyl, remifentanil, and sufentanil, its niche positioning arises from its quick onset and short duration. Fentanyl and remifentanil often supersede alfentanil in advanced anesthesia settings due to better pharmacokinetic profiles, narrowing its market share. However, alfentanil retains relevance in specific protocols demanding rapid recovery.


Financial Trajectory and Revenue Insights

1. Market Size and Revenue Projections

The global opioid analgesics market, valued at USD 7.2 billion in 2022, is projected to grow at a CAGR of approximately 4.5% through 2030 [3]. Although alfentanil accounts for a minor segment within this market, its niche applications ensure steady, albeit modest, revenue streams.

In specialized anesthetic settings, annual sales of alfentanil are estimated in the hundreds of millions USD, with growth primarily driven by emerging markets and procedural volume increases. The limited number of manufacturers constrains supply and maintains pricing stability.

2. Pricing Trends

Pricing for alfentanil remains relatively high due to manufacturing complexity and regulatory compliance costs. Price sensitivity varies across regions, with developed markets bearing premium prices and emerging economies experiencing lower price points, influenced by procurement policies.

3. Patent and Regulatory Status

Most formulations of alfentanil are off-patent, facilitating generic production and competitively priced options, which tends to suppress profit margins for branded manufacturers.


Key Market Drivers

  • Aging Population and Comorbidities: As global elderly populations grow, so does demand for safe, fast-acting analgesics during surgeries.

  • Advancements in Surgical Techniques: Minimally invasive procedures requiring rapid anesthesia induction and recovery favor alfentanil's pharmacokinetics.

  • Increasing Healthcare Spending: Investments in healthcare infrastructure, notably in Asia-Pacific and Latin America, expand procedural volumes and, consequently, alfentanil demand.


Market Constraints and Challenges

  • Opioid Epidemic and Regulatory Crackdowns: Stringent regulations, especially in North America and Europe, limit prescribing and supply, impacting market growth.

  • Competition from Surrogates: The dominance of fentanyl and remifentanil — backed by extensive clinical data and wider acceptance — challenges alfentanil's market penetration.

  • Manufacturing and Supply Risks: Chemical synthesis complexities and regulatory compliance expenses threaten supply stability and cost efficiency.


Emerging Trends and Future Outlook

1. Novel Delivery Systems

Innovations such as transdermal patches or novel formulations could bolster alfentanil's clinical utility, potentially expanding its market.

2. Regional Market Expansion

Emerging economies increasing their procedural capacity and healthcare budgets present opportunities for alfentanil, especially in regions with developing anesthetic protocols.

3. Regulatory Relaxation and Standardization

Streamlined approvals for generic versions may reduce prices, potentially expanding access but impacting profit margins.

4. Competitive Positioning

Innovative positioning emphasizing alfentanil's unique rapid-onset and short-acting profile—especially in outpatient and ambulatory procedures—can sustain its niche status.


Conclusion

Alfentanil's market presents a nuanced landscape dictated by clinical needs, regulatory oversight, and competitive forces. Despite challenges posed by alternatives and regulatory constraints, its unique pharmacological profile sustains demand in specialized contexts. The financial trajectory indicates stable, moderate growth aligned with overall anesthetic and analgesic market trends. Stakeholders should focus on regional expansion, process optimization, and strategic positioning to capitalize on emerging opportunities.


Key Takeaways

  • Steady Demand in Niche Markets: Alfentanil remains relevant for short-duration, rapid-onset anesthesia, sustaining a consistent demand within specialized surgical and ICU settings.

  • Competitive Pressures from Alternatives: Fentanyl and remifentanil dominate due to broader clinical adoption, limiting alfentanil's market share but preserving its niche.

  • Regulatory and Societal Constraints: Tight drug control and the opioid epidemic impact production, distribution, and prescribing practices, influencing profitability and supply chains.

  • Growth in Emerging Markets: Asia-Pacific and Latin America offer expanding procedural volumes, providing future revenue streams if regulatory and supply challenges are managed.

  • Innovation and Regional Expansion: Development of new formulations and targeted regional strategies are vital for maintaining relevance and market growth.


FAQs

1. What are the main clinical advantages of alfentanil over other opioids?
Alfentanil's rapid onset (1-2 minutes) and brief duration (15-30 minutes) make it ideal for procedures requiring quick anesthesia induction and recovery, reducing post-operative sedation time compared to longer-acting opioids.

2. How does the opioid epidemic influence the market for alfentanil?
Heightened regulation and societal awareness limit prescribing practices, restrict supply chains, and incentivize tighter controls to prevent misuse, thereby constraining market growth.

3. Are there new formulations or delivery systems for alfentanil?
Research into novel delivery methods is limited, with most focus on traditional injectable forms. However, ongoing innovations in transdermal patches or controlled-release systems could enhance its utility in the future.

4. What are the primary market competitors to alfentanil?
Fentanyl, remifentanil, and sufentanil dominate the market, offering more extensive clinical data, wider acceptance, and in some cases, more favorable pharmacokinetics.

5. What regions offer the most growth potential for alfentanil?
Emerging markets in Asia, Latin America, and regions with expanding healthcare infrastructure present significant growth opportunities, contingent upon regulatory approvals and supply chain stability.


References

[1] Davis, M. P. (2015). Alfentanil. Anesthesiology, 123(4), 974-975.
[2] World Health Organization. (2021). The International Narcotics Control Board Annual Report.
[3] Grand View Research. (2022). Opioid Analgesics Market Size, Share & Trends Analysis Report.

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