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

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

International Patents for ALFENTA

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

Country	Patent Number	Title	Estimated Expiration
Finland	781398
Hungary	179204	PROCESS FOR PRODUCING N-PHENYL-N-BRACKET-4-PIPERIDINYL-BRACKET CLOSED-AMIDES
Denmark	152211
Netherlands	186861
Denmark	193778
Australia	514360
Norway	148747

Investment Scenario and Fundamentals Analysis of Alfenta (Alfentanil)

Last updated: February 21, 2026

What is the current market position of Alfenta (Alfentanil)?

Alfenta (alfentanil) is a short-acting opioid analgesic primarily used in anesthesia. Marketed for intravenous use, it is available under brands like Alfenta by Hospira (Pfizer). Its key application is in surgical procedures requiring rapid, short-duration analgesia or anesthesia induction.

The global opioid analgesics market, valued at USD 11.2 billion in 2022, exhibits steady growth driven by expanding surgical procedures and rising pain management needs. Alfentanil holds a niche segment within intravenous opioids, competing with drugs like fentanyl and remifentanil.

What is the competitive landscape?

Drug	Duration of Action	Approved Indications	Market Share (est.)	Key Competitors
Alfentanil	Short (10-15 min)	Anesthesia induction, analgesia	Minor segment	Fentanyl, Remifentanil
Fentanyl	Longer (30-60 min)	Pain management, anesthesia	Largest segment	Alfentanil, Remifentanil
Remifentanil	Very short (~3-10 min)	Anesthesia, sedation	Growing segment	Fentanyl, Alfentanil

Despite its niche utility, Alfentanil is a mature product with limited pipeline growth due to the dominance of fentanyl derivatives and remifentanil.

What are the regulatory and manufacturing considerations?

Alfentanil is regulated as a controlled substance (Schedule II in US). The manufacturing process involves complex synthesis requiring strict controls. Patent protection largely expired in several jurisdictions, leading to generic availability.

Development bottlenecks include:

• Strict regulatory oversight
• Controlled substance handling costs
• Capacity constraints in production of high-containment drugs

What does the pipeline look like?

There are no significant innovations or reformulations under development aimed at extending Alfentanil's patent life or improving its efficacy. Emerging trends favor alternative agents with longer or more controllable durations of action and fewer side effects.

What are the key financial metrics?

Metric	2022 (Est.)	Notes
Market size (global)	USD 11.2 billion	Overall opioid analgesic market
Alfentanil share	Minor	Niche segment
Average price (per dose)	USD 10-20	Influenced by manufacturing costs and regulations
Patent expiration	Expired / No active patents	Same across major jurisdictions

Revenue potential remains limited because of the mature product status and competition from generics. Margins are also under pressure due to regulatory compliance costs and manufacturing complexity.

What are the investment risks?

• Market saturation with generics
• Stringent regulation increasing compliance costs
• Potential for shift to alternative analgesics or delivery methods
• Legal and liability risks associated with controlled substances
• Limited pipeline for innovation

What are growth drivers and opportunities?

• Emerging markets with expanding surgical volumes
• Adoption of generic options reducing costs
• New formulations enabling different delivery modalities
• Integration into broader anesthetic protocols

Conclusion

Alfenta's (alfentanil) market is mature with limited growth prospects. Dominated by generic manufacturers, it faces intense competition and regulatory constraints. Investment opportunities are primarily in maintaining existing market share or exploiting niche applications, rather than in high-growth scenarios.

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Key Takeaways

• Alfentanil is a mature, generic intravenous opioid with a small niche market.
• Market growth is constrained by competing drugs (fentanyl, remifentanil) and regulatory costs.
• Patent expiry has led to widespread generic availability, limiting pricing power.
• Regulatory and manufacturing complexities add operational risks.
• Emerging markets and potential new formulations offer limited growth avenues.

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FAQs

1. What conditions limit Alfentanil's market growth?
Market dominance by fentanyl and remifentanil, patent expirations, regulatory costs, and availability of alternatives restrict its growth.

2. Are there new formulations of Alfentanil under development?
No significant new formulations or reformulations are currently in development for Alfentanil.

3. How does the regulatory environment impact Alfentanil?
As a Schedule II controlled substance, it faces strict manufacturing, handling, and distribution regulations, increasing compliance costs.

4. What are the main competitors to Alfentanil?
Fentanyl and remifentanil dominate the intravenous opioid segment with broader indications and longer durations.

5. Is there potential for regional market expansion?
Yes, particularly in emerging markets with increasing surgical procedures. But market penetration remains limited by the drug's niche status and existing competition.

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References

[1] MarketWatch. (2023). Global opioids market size, share, growth. Retrieved from https://www.marketwatch.com

[2] U.S. Food and Drug Administration. (2022). Schedule II controlled substances. https://www.fda.gov

[3] Statista. (2022). Global analgesics market. https://www.statista.com

[4] Pfizer Inc. (2021). Alfenta product information. https://www.pfizer.com

[5] WHO. (2020). Opioid analgesics in pain management. https://www.who.int