ALFENTANIL Drug Patent Profile

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 is one drug master file entry for this compound. Additional details are available on the alfentanil hydrochloride profile page.

Summary for ALFENTANIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	57
Patent Applications:	7,341
Drug Prices:	Drug price information for ALFENTANIL
What excipients (inactive ingredients) are in ALFENTANIL?	ALFENTANIL excipients list
DailyMed Link:	ALFENTANIL at DailyMed

See drug prices for ALFENTANIL

Recent Clinical Trials for ALFENTANIL

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

Sponsor	Phase
The First Affiliated Hospital of Xinxiang Medical College	PHASE4
Diansan Su	NA
WeiGong Memorial Hospital	NA

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

Alfentanil Market Dynamics, Patent Status, FDA Exclusivity, and Financial Outlook

Last updated: September 25, 2026

Alfentanil is a mature, short-acting synthetic opioid anesthetic with limited commercial scale and no meaningful remaining brand exclusivity in the United States. Its market is driven by hospital anesthesia demand, generic injectable supply, controlled-substance compliance, and procurement reliability rather than consumer prescribing or product differentiation. Public company filings do not separately report alfentanil revenue, so the drug’s financial trajectory must be assessed through market structure, product availability, anesthesia utilization, and generic pricing.

What is alfentanil and how is it used?

Alfentanil is an intravenous opioid analgesic used as an adjunct to general anesthesia and for the induction and maintenance of anesthesia. It has a rapid onset and short duration of action because of its pharmacokinetic profile. The drug is administered in hospitals and procedural settings under anesthesia supervision.

The U.S. reference product, Alfenta, was originally approved by the Food and Drug Administration as an injectable formulation. Current labeling identifies alfentanil hydrochloride injection as a potent opioid requiring controlled administration, respiratory monitoring, and appropriate reversal and resuscitation equipment. [1][2]

Attribute	Alfentanil
Active ingredient	Alfentanil hydrochloride
Therapeutic class	Opioid analgesic; anesthetic adjunct
Route	Intravenous injection
Primary setting	Operating rooms, procedural anesthesia, hospital care
U.S. controlled-substance classification	Schedule II
Commercial form	Sterile injectable solution
Reference brand	Alfenta
Current market structure	Generic and institutional
Biosimilar relevance	None
Consumer pharmacy exposure	Minimal

Alfentanil is not a chronic pain product. Its revenue base therefore depends on procedure volume, operating-room utilization, anesthesia protocols, and hospital purchasing contracts.

When does alfentanil lose exclusivity?

Alfentanil lost practical market exclusivity decades ago. The original product was approved in the 1980s, and the active ingredient is now supplied through a mature generic injectable market. No current regulatory exclusivity period materially limits generic competition in the United States.

What is the Orange Book status of alfentanil?

The FDA Orange Book historically listed the reference product and related regulatory information for Alfenta. Any original patents or regulatory protections associated with the branded product are no longer commercially meaningful for current U.S. market access. The product’s market is consistent with an off-patent injectable in which generic approval, manufacturing capacity, and purchasing contracts determine competition. [3]

The practical exclusivity position is:

Exclusivity category	Current commercial effect
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	Not commercially relevant
New formulation exclusivity	No material protection identified
Active U.S. patent barrier	No material blocking barrier identified
Generic competition	Permitted
Paragraph IV exposure	Low strategic significance because the core product is off-patent

The absence of a meaningful patent barrier does not guarantee uninterrupted supply. Injectable opioids can remain exposed to manufacturing disruptions because production requires sterile facilities, controlled-substance handling, validated filling processes, and regulatory compliance.

How many patents cover alfentanil?

No active patent estate appears to provide significant market protection for the basic alfentanil injection product in the United States.

What formulations are protected by alfentanil patents?

Alfentanil’s commercially established dosage form is a sterile intravenous injection. The product does not have the layered formulation-patent profile associated with newer extended-release injectables, transdermal systems, inhaled medicines, or complex drug-delivery platforms.

Potential technical barriers relate more to manufacturing than to patent exclusivity. These may include:

• Sterile injectable production
• Container-closure integrity
• Concentration control
• Stability and preservative specifications
• Controlled-substance security
• Validated analytical methods
• Compliance with FDA current good manufacturing practice requirements

Those requirements can restrict the number of reliable suppliers even when legal entry is open.

Are there method-of-use patents for alfentanil?

No commercially significant method-of-use patent position is associated with the established anesthesia indications. Alfentanil’s principal use is conventional perioperative analgesia and anesthesia support. It does not have a broad, active method-of-use estate comparable to products protected for a newly approved disease indication.

What is the FDA regulatory status of alfentanil?

Alfentanil is an FDA-approved prescription injectable opioid. FDA labeling covers use as an analgesic adjunct during anesthesia and specifies dosing, respiratory monitoring, drug interactions, and warnings associated with opioid administration. [1]

The regulatory profile is mature:

Regulatory issue	Assessment
FDA approval	Established
Dosage form	Injectable solution
Prescription status	Yes
Controlled substance	Schedule II
Generic pathway	Abbreviated New Drug Application pathway
REMS-driven commercial differentiation	No major product-specific differentiation
Biosimilar pathway	Not applicable
Hospital-use restrictions	Controlled-substance and anesthesia oversight

Because alfentanil is a small-molecule injectable, competitors enter through generic drug approval rather than through the biosimilar pathway used for biologics.

Which companies are challenging alfentanil’s market?

The competitive threat comes primarily from therapeutic substitutes and generic suppliers rather than from branded patent challengers.

How does alfentanil compare with fentanyl, remifentanil, and sufentanil?

Product	Competitive position	Main commercial advantage	Main limitation relative to alfentanil
Fentanyl	Broadest substitute base	Familiarity, availability, low cost, multiple dosage forms	Longer and less predictable duration in some settings
Remifentanil	Direct anesthesia substitute	Very short, rapidly controllable effect	Often higher acquisition cost and greater dependence on anesthesia protocols
Sufentanil	Potent opioid alternative	High potency and established anesthesia use	Smaller market and narrower routine use
Alfentanil	Niche anesthesia opioid	Rapid onset and short duration	Limited scale and lower formulary priority

Fentanyl is the largest competitive reference point because hospitals use it across anesthesia, emergency medicine, intensive care, and procedural care. Remifentanil competes more directly in cases requiring rapid titration and fast recovery. Sufentanil competes in selected anesthesia and analgesia settings.

The substitution pattern limits alfentanil’s pricing power. Hospitals can often switch protocols or products when a supplier raises prices, experiences a shortage, or loses formulary preference.

What drives the alfentanil market?

Alfentanil demand is linked to operating-room volume, procedural anesthesia, and clinician preference. It is not materially exposed to direct-to-consumer promotion.

The main demand drivers are:

1. Elective and emergency surgical procedures.
2. Hospital and ambulatory surgery center utilization.
3. Anesthesia protocols requiring rapid onset and short duration.
4. Recovery-time targets in outpatient procedures.
5. Availability of competing opioids.
6. Hospital group-purchasing contracts.

Demand is relatively stable but small compared with fentanyl. Growth is unlikely to come from a major new indication. The market therefore tracks procedure volume and supply continuity rather than pharmaceutical innovation.

What market risks affect alfentanil supply?

The most important risks are operational:

• Limited sterile injectable manufacturing capacity
• Active pharmaceutical ingredient availability
• Controlled-substance quota management
• Product discontinuations
• Hospital inventory reductions
• Regulatory inspection findings
• Temporary shortages affecting anesthesia departments

Generic injectable markets can support several nominal suppliers while remaining concentrated in actual production. A supplier exit can create disproportionate market disruption even without a patent dispute.

What is the financial trajectory for alfentanil?

Alfentanil’s financial trajectory is mature, low-growth, and procurement-driven. It does not have the characteristics of a high-value specialty medicine or a branded growth product.

Is alfentanil revenue publicly reported?

Public companies generally do not report alfentanil revenue as a separate product line. Sales are typically aggregated within broader hospital injectable, generic, anesthesia, or critical-care portfolios. As a result, a verified global alfentanil revenue figure cannot be derived from public annual reports alone.

The economic profile is best described as follows:

Financial variable	Outlook
Volume growth	Low; tied to procedure growth
Price growth	Limited under normal supply conditions
Gross-margin potential	Moderate only where supply is constrained
Brand premium	Minimal
Promotional spending	Low
Development spending	Minimal
Revenue visibility	Low at individual-product level
Downside risk	Supplier exit, substitution, and procurement pressure
Upside catalyst	Sustained shortage or additional institutional demand

Generic competition suppresses prices during periods of adequate supply. Temporary shortages can create price increases, but those gains are usually episodic rather than structural. Hospitals may also respond to elevated pricing by substituting fentanyl or remifentanil when clinically acceptable.

Which companies have the greatest revenue exposure?

Large generic and hospital-product manufacturers may carry alfentanil within broad portfolios, but company-level exposure is difficult to isolate because filings usually group products by therapeutic area or business segment. Alfentanil is unlikely to represent a material share of revenue for diversified manufacturers.

The highest exposure would occur at a smaller supplier with:

• A limited anesthesia portfolio
• Few competing opioid products
• Concentrated hospital contracts
• A single sterile manufacturing site
• High dependence on one or two wholesalers

For diversified companies, alfentanil is more likely to contribute incremental portfolio revenue than a material change in corporate earnings.

What generic entry risks exist for alfentanil?

Generic entry risk is high in legal terms and moderate in commercial terms.

Legal entry is open because the principal product is old and lacks meaningful market exclusivity. Commercial entry remains constrained by the economics of sterile injectable production. A new entrant must establish reliable manufacturing, controlled-substance compliance, hospital distribution, and supply continuity.

Are there Paragraph IV challenges involving alfentanil?

Paragraph IV litigation is not a central current risk for alfentanil. Paragraph IV challenges are most valuable when a branded product has significant remaining patent life and high anticipated sales. Alfentanil does not present that profile.

The more relevant competitive events are:

• Abbreviated New Drug Application approvals
• Supplier launches or withdrawals
• FDA manufacturing inspections
• Drug-shortage notifications
• Hospital contract changes
• Substitution toward fentanyl or remifentanil

What patent litigation affects alfentanil?

No major contemporary U.S. patent litigation materially defines the alfentanil market. The commercial dispute profile is more likely to involve supply contracts, manufacturing quality, procurement, or regulatory compliance than infringement claims.

What settlement agreements affect alfentanil?

No major current branded-generic settlement structure is central to alfentanil’s market. The drug’s commercial status does not depend on a delayed generic-entry agreement or a negotiated patent settlement.

What manufacturing and IP barriers remain?

Alfentanil has limited intellectual-property protection but meaningful execution barriers. A supplier must manage a controlled opioid and produce a sterile injectable that satisfies FDA quality requirements.

The most important barriers are:

• Access to qualified sterile fill-finish capacity
• Consistent active-ingredient supply
• Controlled-substance recordkeeping
• FDA-compliant validation
• Hospital purchasing qualification
• Reliable distribution through wholesalers
• Ability to maintain supply during demand spikes

These barriers can preserve a small number of dependable suppliers without creating patent-based pricing power.

How strong is the alfentanil patent estate?

The patent estate is weak from a current commercial perspective. The basic product is mature, generic, and not protected by a high-value formulation or delivery platform. The stronger competitive assets are manufacturing reliability, regulatory history, hospital relationships, and supply continuity.

For investors and licensing teams, alfentanil is therefore an operational portfolio product rather than an IP-led asset. An acquisition thesis based on patent exclusivity would have little support. A supply-focused thesis could have value if tied to sterile capacity, shortage resilience, or a broader perioperative injectable portfolio.

What are the likely generic launch scenarios?

Three scenarios define the market:

Scenario	Market effect	Financial result
Stable multi-supplier supply	Hospitals retain multiple options	Low price growth and modest, predictable revenue
Supplier disruption	Hospitals seek replacement inventory	Temporary volume and pricing opportunity for available suppliers
Persistent shortage	Formulary substitution accelerates	Higher short-term value, followed by demand erosion as alternatives expand

The base case is stable but low-growth generic demand. The upside case depends on supply disruption rather than product innovation. The downside case is loss of formulary relevance to fentanyl, remifentanil, or other anesthesia protocols.

Key Takeaways

• Alfentanil is an established Schedule II intravenous opioid used mainly as an anesthesia adjunct.
• U.S. market exclusivity expired long ago, and no material active patent barrier controls generic entry.
• The product has no biosimilar exposure because it is a small-molecule drug.
• Paragraph IV litigation and patent settlements are not major current market drivers.
• Revenue is not separately disclosed by most manufacturers.
• Financial performance depends on procedure volume, hospital purchasing, generic pricing, and sterile injectable supply.
• Fentanyl and remifentanil are the most important commercial substitutes.
• Manufacturing reliability and controlled-substance compliance matter more than intellectual property.
• The base-case outlook is mature, low-growth, and procurement-driven.
• Shortages can create temporary pricing power, but they do not establish durable franchise value.

FAQs about alfentanil market dynamics and exclusivity

Is alfentanil still commercially available in the United States?

Alfentanil injection has been marketed in the United States through FDA-approved products and generic suppliers, although product availability can vary by manufacturer, distributor, and presentation.

Does alfentanil have a current U.S. patent?

No material current patent barrier is associated with the established alfentanil injection market. The drug is commercially treated as a mature generic product.

Can hospitals replace alfentanil with fentanyl?

Yes. Fentanyl is a major therapeutic substitute, although the products differ in pharmacokinetics, dosing, duration, and clinical use. Substitution decisions are made by anesthesia teams and hospital formularies.

Is alfentanil subject to FDA drug-shortage risk?

Yes. As a sterile injectable controlled substance, alfentanil can be exposed to manufacturing interruptions, supplier exits, distribution constraints, and temporary shortages.

Is alfentanil an attractive licensing opportunity?

The opportunity is more likely to involve manufacturing capacity, supply reliability, or a broader hospital injectable portfolio than proprietary intellectual property or branded pricing power.

References

1. U.S. Food and Drug Administration. (n.d.). Alfenta: Alfentanil hydrochloride injection prescribing information. FDA Drugs@FDA.

2. U.S. National Library of Medicine. (n.d.). Alfentanil hydrochloride injection. DailyMed.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA, Center for Drug Evaluation and Research.

4. U.S. Drug Enforcement Administration. (2024). Controlled substances by schedule. U.S. Department of Justice.

5. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA, Center for Drug Evaluation and Research.