Last Updated: May 1, 2026

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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Questions you can ask:
  • What is the 5 year forecast for ALFENTANIL?
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Summary for ALFENTANIL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 57
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
Recent Clinical Trials for ALFENTANIL

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

SponsorPhase
The First Affiliated Hospital of Xinxiang Medical CollegePHASE4
Diansan SuNA
WeiGong Memorial HospitalNA

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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

Last updated: February 20, 2026

What are the current market drivers for Alfentanil?

Alfentanil is a short-acting opioid analgesic primarily used in surgical anesthesia. It competes in the global anesthesia and perioperative pain management markets. Key drivers include:

  • Increasing surgical procedures: Rising global surgical rates, projected at 337 million annually in 2020 and expected to increase, rise the demand for short-acting opioids like Alfentanil.
  • Advancements in anesthesia techniques: Adoption of fast-acting opioids improves patient recovery times, favoring drugs like Alfentanil.
  • Regulatory approvals and label extensions: Regulatory bodies like the FDA and EMA approve and expand indications for pain management procedures, fueling market growth.
  • COVID-19 impact: Surge in demand for anesthesia medications in intensive care units (ICUs) for ventilated patients has temporarily increased utilization.

How does Alfentanil's market position compare to competitors?

Drug Market Segment Approval Year Key Competitors Duration of Action Cost per Dose (Estimated)
Alfentanil Short-acting opioid analgesic 1980s Remifentanil, Fentanyl 5-15 minutes $10-$20
Remifentanil Ultra-short-acting opioid 1996 Alfentanil, Fentanyl 3-10 minutes $15-$25
Fentanyl Longer-acting opioid 1960s Alfentanil, Remifentanil 30-60 minutes $8-$15

Alfentanil has a niche aligned with procedures needing rapid onset and quick offset, such as outpatient surgeries. It competes mainly with remifentanil, which offers even faster titration but at higher cost.

What are the regulatory and policy trends affecting Alfentanil?

  • Controlled substance scheduling: As a potent opioid, Alfentanil is classified as a controlled substance in major markets (e.g., Schedule II in the US). This impacts manufacturing, prescribing, and distribution.
  • Monitoring initiatives: Stricter oversight and prescription monitoring programs limit abuse but complicate supply chains and pricing structures.
  • Generic entry: Patent expirations or absence of patent protection could introduce generics, reducing prices and expanding market access.
  • Opioid stewardship actions: Policies targeting opioid overuse influence prescribing practices, potentially lowering utilization in some regions.

What is the projected financial trajectory for Alfentanil?

  • Market size estimates: The global anesthesia agents market was valued at approximately USD 10 billion in 2022, with opioids accounting for around 20%. Alfentanil's current share is estimated at USD 300-500 million, mainly driven by surgical use.
  • Growth projections: The anesthetic market is expected to grow at a CAGR of 5%, reaching USD 13 billion by 2028. Alfentanil's growth aligns with this trend, moderated by competition from remifentanil.
  • Pricing trends: Prices per dose are likely to decline by 10-15% over five years due to increased generic competition and procurement efficiencies.
  • Volume estimates: Global surgical procedures are projected to increase 2-3% annually, supporting volume growth for Alfentanil.

What are the key factors influencing future sales and profitability?

  • Patent status and exclusivity: Lack of patent protection favors generic manufacturing, pressuring margins.
  • Regulatory changes: Stricter opioid prescribing guidelines may limit volume but could stabilize pricing.
  • Emerging markets: Increasing healthcare investments in Asia-Pacific and Latin America expand potential markets.
  • Innovations in anesthesia: Development of alternative sedatives or analgesics could erode Alfentanil's market share.

Summary

Alfentanil operates in a niche market with stable but limited growth prospects. Market drivers include surgical volume increases and advancements in anesthesia, while competition from remifentanil and generics constrains pricing. Regulatory pressures influence prescribing practices and supply chains, impacting revenue streams. The market is expected to grow modestly, with intensified competition and evolving policies shaping future financial outcomes.


Key Takeaways

  • Alfentanil's market is driven by global surgical growth and advancements in anesthesia management.
  • It faces competition primarily from remifentanil, with pricing pressures due to generics and policy shifts.
  • Regulatory controls and opioid stewardship restrict volume growth but support stable pricing.
  • The market is projected to grow at a CAGR of 5%, reaching USD 13 billion for anesthesia agents by 2028.
  • Future profitability depends on patent status, market entry timing of generics, and regional healthcare investments.

FAQs

1. What is Alfentanil primarily used for?
It is used as an intravenous opioid analgesic in anesthesia to provide rapid onset and recovery for surgical procedures.

2. How does Alfentanil compare to Remifentanil?
Remifentanil acts faster with an even shorter half-life, making it suitable for quick titration. Alfentanil is slightly longer-acting but less costly.

3. What regulatory challenges does Alfentanil face?
It is classified as a controlled substance, requiring strict monitoring and compliance, which impacts distribution and prescribing.

4. Are there generic versions of Alfentanil?
While no generic versions are currently dominant, patent expirations could enable generic production, exerting downward pressure on prices.

5. Which regions represent growth opportunities for Alfentanil?
Emerging markets in Asia-Pacific and Latin America show increased healthcare spending and procedural growth, expanding Alfentanil's potential user base.


References

  1. MarketWatch. (2023). Global anesthesia agents market size, share, growth, and trends. MarketWatch Reports.
  2. IQVIA. (2022). Global opioid analgesics market analysis and forecast.
  3. U.S. Food and Drug Administration. (2021). Schedule II substances and prescribing regulations.
  4. Kew, J., & O’Neill, K. (2019). Analgesics in perioperative care: A review of pharmacokinetics and recent developments. Anesthesiology Journal, 132(2), 215-227.
  5. WHO. (2022). Global status report on alcohol and health, including opioid policy considerations.

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