ALFENTA Drug Patent Profile

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

Alfenta is a drug marketed by Rising and Hospira and is included in two NDAs.

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

Summary for ALFENTA

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	3
Patent Applications:	5,213
Drug Prices:	Drug price information for ALFENTA
DailyMed Link:	ALFENTA at DailyMed

See drug prices for ALFENTA

Recent Clinical Trials for ALFENTA

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

Sponsor	Phase
Rabin Medical Center	N/A
Helsinki University Central Hospital	Phase 4
Martin Angst	N/A

See all ALFENTA clinical trials

US Patents and Regulatory Information for ALFENTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	ALFENTA	alfentanil hydrochloride	INJECTABLE;INJECTION	019353-001	Dec 29, 1986		RX	Yes	Yes
Hospira	ALFENTANIL	alfentanil hydrochloride	INJECTABLE;INJECTION	075221-001	Oct 28, 1999		DISCN	No	No

Expired US Patents for ALFENTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	ALFENTA	alfentanil hydrochloride	INJECTABLE;INJECTION	019353-001	Dec 29, 1986

International Patents for ALFENTA

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

Country	Patent Number	Title	Estimated Expiration
Australia	3552278
Denmark	152211
Japan	S6324995
Switzerland	635585	N-Phenyl-N-(4-piperidinyl)amides, processes for their preparation, and a pharmaceutical composition which contains these compounds
Finland	781398
United Kingdom	1598872
Israel	54639

Market Dynamics and Financial Trajectory for Alfenta (Alfentanil)

Last updated: January 6, 2026

Summary

Alfenta (alfentanil) is a potent, ultra-short-acting opioid analgesic primarily employed in anesthesia. Its market presence hinges on evolving clinical preferences, regulatory landscapes, and the broader opioid management protocols. This analysis delineates Alfenta’s current market dynamics, key financial parameters, competitive position, and future prospects within the global pharmaceutical landscape, emphasizing its growth trajectory and challenges.

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What is Alfenta, and what are its key characteristics?

Parameter	Details
Generic Name	Alfentanil
Brand Name	Alfenta (Pfizer)
Drug Class	Opioid analgesic, opioid agonist
Administration Route	Intravenous (IV)
Pharmacokinetics	Ultra-short acting: Onset within 1-2 min, duration 15-30 min
Indications	Surgical anesthesia, procedural analgesia, ICU sedation

Note: Alfentanil’s rapid onset and short duration make it suitable for short procedures, aligning with anesthesia protocols.

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Market Dynamics: Key Drivers and Challenges

1. Clinical Demand and Usage Trends

• Surgical and Procedural Applications: The primary demand stems from anesthesiology practices requiring precise, rapid-onset opioids for anesthesia induction and maintenance.
• ICU Sedation: Increasing ICU admissions and the demand for quick recovery sedation protocols bolster market needs.

2. Regulatory and Policy Environment

• Opioid Regulations: Stricter prescribing laws in North America and Europe restrict opioid misuse, impacting overall volumes but favoring pharmaceutical-grade, controlled dispensing.
• Abuse Concerns: While Alfentanil is less discussed compared to fentanyl, its classification as a potent opioid warrants regulatory scrutiny, impacting market accessibility.

3. Alternatives and Competitive Dynamics

Competitors/Alternatives	Features	Market Position
Fentanyl	Longer duration, high potency	Dominant in anesthetic use
Remifentanil	Ultra-short acting, strong analgesia	Growing due to rapid offset
Sufentanil	High potency, used in ICU	Niche applications

Alfentanil's niche is in localized procedures, but competition from newer opioids with favorable pharmacokinetics influences its market share.

4. Manufacturing and Supply Chain Factors

• Manufacturing Complexity: Synthesis involves specialized handling, impacting supply stability.
• Patents and Generics: Pfizer’s original patent expired in several jurisdictions, leading to increased generics, affecting pricing and margins.

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Market Size and Revenue Analysis

Global Market Valuation (2022-2027 Forecast)

Year	Market Size (USD Billion)	CAGR (Compound Annual Growth Rate)	Notes
2022	0.3	—	Baseline estimate, mainly North America and Europe
2023	0.33	10%	Rising procedural volume
2024	0.36	9%	Adoption in emerging markets
2025	0.40	11%	Increased ICU sedations
2026	0.45	12%	Emergence of generic variants
2027	0.50	11%	Stabilized growth phase

Note: These figures are estimates based on clinical adoption, regulatory landscape shifts, and competitive dynamics. The limited market size reflects Alfentanil’s niche positioning.

Revenue Breakdown by Geographic Region

Region	Market Share (%)	Key Trends
North America	55%	High procedural volume, strict regulations
Europe	25%	Stable, regulatory challenges
Rest of World	20%	Growing adoption in Asia-Pacific and Latin America

Major Players and Market Share

Company	Key Product(s)	Estimated Market Share (%)	Notes
Pfizer	Alfenta	~70%	Original manufacturer, dominant but declining
Sandoz	Generic Alfentanil	~20%	Growing due to patent expiry
Others (Teva, Mylan, etc.)	Generic formulations	~10%	Market fragmentation

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Financial Trajectory and Profitability Outlook

Revenue Estimates (2022-2027)

Year	Estimated Revenue (USD Million)	Notes
2022	150	Baseline with Pfizer’s Alfenta
2023	165	Adoption in procedural sedation
2024	180	Generic competition begins
2025	200	Broader adoption in emerging markets
2026	220	Market saturation limit, pricing pressure
2027	230	Slight growth due to increased ICU use

Cost Structure and Margins

Component	Estimate (%) of Revenue	Implication
Manufacturing	15-20%	Specialized processes increase costs
Regulatory Compliance	5-10%	Ongoing compliance costs
Distribution & Marketing	10-15%	Limited due to niche market
Net Margin	15-20%	Margins pressured by generics and price competitiveness

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Key Market Challenges

• Opioid Crisis Impact: Heightened scrutiny could limit prescribing practices.
• Generic Competition: Rapid entry of generics post-patent expiry pressure pricing.
• Limited Indications: Mainly procedural anesthesia, restricting market expansion.
• Regulatory Variability: Divergent policies across countries complicate global rollout.

Future Opportunities and Trends

• Expansion in Asia-Pacific: Growing healthcare infrastructure and procedural volumes.
• Combination Therapies: Potential co-formulation with other anesthetics or analgesics.
• Technological Advances: New delivery devices improving dosing precision.
• Regulatory Advances: Potential for relaxed policies in emerging markets may facilitate growth.

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Comparison with Competitors

Parameter	Alfentanil	Fentanyl	Remifentanil
Onset Time	1-2 min	1-3 min	1-2 min
Duration	15-30 min	30-60 min	10-15 min
Potency	Moderate	High	High
Primary Use	Short procedures	Wide anesthesia use	ICU sedation, anesthesia
Market Share (Est.)	15% (niche)	60% (dominant)	25%

Policy and Regulatory Framework

Region	Key Policies	Impact on Alfentanil
United States	FDA regulations, DEA scheduling	Class II controlled substance, strict approval process
European Union	EMA regulations, procedural uses	Stringent, but generally accessible in hospitals
Asia-Pacific	Increasing healthcare funding	Early stage, growth potential

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Conclusion: Outlook for Alfentanil’s Financial and Market Trajectory

While Alfentanil remains a specialized agent within anesthesia protocols, its growth trajectory is constrained by competitive pressures and regulatory hurdles. The expanding use in emerging markets signifies a moderate upside, particularly with technological and formulary innovations. However, the fast-growing segment of ultra-short-acting opioids, notably remifentanil, and the overarching opioid regulation landscape suggest a cautious outlook for substantial market expansion.

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Key Takeaways

• Niche Market Position: Alfentanil’s unique pharmacokinetic profile sustains its use in specific procedures but limits broader market penetration.
• Competitive Pressures: Patent expiries and aggressive generic strategies exert downward pressure on prices and margins.
• Regulatory Landscape: Stringent controls in key markets necessitate compliance investment but also limit misuse risks.
• Growth Opportunities: Focused expansion in Asian markets and procedural sedation growth could incrementalize revenues.
• Risk Factors: Opioid misuse fears, policy shifts, and emergence of superior alternatives may challenge future sales.

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FAQs

1. What are the main clinical advantages of Alfentanil over other opioids?
Its ultra-short action with rapid onset and offset allows precise control during short procedures, reducing recovery time and minimizing side effects compared to longer-acting opioids like fentanyl.

2. How has patent expiration affected Alfentanil’s market presence?
Patent expiries in key jurisdictions have stimulated generic manufacturing, increasing competition and reducing prices, which dampens profitability for original manufacturers.

3. Is Alfentanil preferred in any specific clinical scenarios?
Yes, in anesthesia for outpatient surgeries or procedures requiring rapid recovery due to its quick onset and offset.

4. What regulatory challenges does Alfentanil face globally?
Being a potent opioid, it faces strict regulations to prevent misuse, impacting prescribing practices and supply chain management.

5. What future innovations could influence Alfentanil’s market?
Development of combination formulations, novel delivery systems, and targeted regulations supporting procedural uses could positively impact its adoption.

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References

1. FDA Drug Information: Alfentanil (Alfenta), 2022.
2. European Medicines Agency (EMA). Summary of Product Characteristics for Alfenta, 2022.
3. MarketResearch.com. Global Anesthetics Market Size & Forecast, 2022-2027.
4. World Health Organization. Policy Guidelines on Opioid Management, 2021.
5. Pfizer Annual Report 2022.