Fentanyl hydrochloride - Generic Drug Details

What are the generic sources for fentanyl hydrochloride and what is the scope of patent protection?

Fentanyl hydrochloride is the generic ingredient in one branded drug marketed by The Medicines Co and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fentanyl hydrochloride has eighty-six patent family members in eighteen countries.

There are two drug master file entries for fentanyl hydrochloride.

Summary for fentanyl hydrochloride

International Patents:	86
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	1,882
DailyMed Link:	fentanyl hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fentanyl hydrochloride

Dosage:

SYSTEM;IONTOPHORESIS, TRANSDERMAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for fentanyl hydrochloride

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

Sponsor	Phase
Christopher D. Verrico	PHASE1
Baylor College of Medicine	PHASE1
Montefiore Medical Center	PHASE3

See all fentanyl hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for fentanyl hydrochloride

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N02AB	Phenylpiperidine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for fentanyl hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No			Y

Expired US Patents for fentanyl hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006

International Patents for fentanyl hydrochloride

Country	Patent Number	Title	Estimated Expiration
Brazil	112014028909	autoteste para produto analgésico
Russian Federation	2013148574	СПОСОБ И СХЕМА ПРОВЕРКИ ИСПРАВНОСТИ ВЫКЛЮЧАТЕЛЯ
New Zealand	702360	Current control for electrotransport drug delivery
Russian Federation	2014151720	САМОТЕСТИРОВАНИЕ ДЛЯ ОБЕЗБОЛИВАЮЩЕГО СРЕДСТВА

Supplementary Protection Certificates for fentanyl hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0383579	C960030	Netherlands		PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831

Market Dynamics and Financial Trajectory for Fentanyl Hydrochloride

Last updated: July 29, 2025

Introduction

Fentanyl hydrochloride, an ultra-potent synthetic opioid, plays a critical role in pain management, notably in anesthesia and palliative care. Its high potency—approximately 80 to 100 times that of morphine—renders it both valuable and scrutinized. The global pharmaceutical landscape's interest in fentanyl derivatives reflects evolving medical needs, regulatory pressures, and ongoing attempts to balance therapeutic benefits against misuse risks. This article examines the geopolitical, clinical, regulatory, and economic forces shaping the fentanyl hydrochloride market, alongside its projected financial trajectory over the next decade.

Market Overview and Key Drivers

Clinical and Therapeutic Utilization

Fentanyl hydrochloride's primary applications encompass perioperative anesthesia, chronic pain management for cancer patients, and breakthrough pain. The molecule's efficacy in delivering rapid, potent analgesia with predictable pharmacokinetics underscores its clinical dominance. The worldwide aging population and increasing prevalence of chronic pain conditions bolster demand. Moreover, innovations in transdermal patches, lozenges, and injectable formulations enhance market penetration.

Medical Advancements and Innovation

Research continues into novel delivery platforms—such as buccal films and intravenous systems—aimed at optimizing dosing and patient compliance. The push toward personalized pain management fosters ongoing adoption of fentanyl-based therapies, reinforcing market size and growth prospects.

Regulatory Environment and Policy Shifts

Regulatory frameworks significantly influence the fentanyl market. Authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce stringent drug scheduling, manufacturing standards, and distribution controls to prevent misuse. While these measures aim to curtail illicit diversion, they inadvertently complicate legal manufacturing and distribution, impacting market dynamics.

Illicit Market and Diversion Risks

A vital factor affecting market perceptions is the proliferation of illicit fentanyl, associated with the opioid crisis, primarily in North America. Illegal manufacture and smuggling of fentanyl and its analogs have led to increased overdose rates, prompting tighter border controls and regulatory scrutiny. Consequently, demand for pharmaceutical-grade fentanyl faces tension from illicit counterparts, influencing pricing and market stability.

Supply Chain and Manufacturing Considerations

Production involves complex chemical synthesis and rigorous compliance frameworks. Geopolitical issues, such as trade restrictions and sourcing of precursor chemicals—mainly from China—can disrupt manufacturing capacity, affecting prices and supply stability.

Market Challenges and Risks

Legal and Ethical Concerns

The opioid epidemic has prompted widespread policy reforms. Increased sanctions, cracking down on illicit distribution, and tighter prescribing guidelines pose challenges for pharmaceutical companies. Balancing legitimate clinical needs against the risk of diversion remains a persistent ethical and operational concern.

Pricing and Reimbursement Dynamics

While fentanyl hydrochloride commands premium pricing due to its potency, insurance and government reimbursement policies affect profitability. As alternative analgesics emerge, market share concentration may shift, exerting downward pressure on prices.

Regulatory Hurdles

Evolving regulations, including scheduling adjustments and strict manufacturing practices, heighten compliance costs. The need for secure supply chain management and robust controlled substance handling further escalates operational expenditures.

Financial Trajectory and Market Forecasts

Market Size and Growth Projections

The global fentanyl market is anticipated to grow steadily, driven chiefly by clinical applications. According to Market Research Future, the opioid analgesics market could reach approximately USD 13.8 billion by 2027, with fentanyl derivatives comprising a substantial share. The North American market dominates due to high prescription rates and advanced healthcare infrastructure.

Emerging Markets and Geographical Trends

Emerging regions, particularly Asia-Pacific, exhibit increasing adoption of opioid analgesics, driven by expanding healthcare access and rising chronic pain incidences. However, regulatory adoption varies, and illegal market activity remains a concern. Europe shows cautious growth, balancing clinical demand with strict regulations.

Impact of Patent and Generic Markets

Patents on branded fentanyl formulations—such as Duragesic—expire over the next decade, fostering generic entry and intensifying price competition. This phenomenon could reduce revenue streams for innovator companies but may expand overall access.

Investment Outlook

Biopharmaceutical firms investing in novel formulations or delivery systems are expected to see growth prospects. Conversely, companies heavily reliant on high-dose formulations face revenue pressures as market saturation and regulatory oversight intensify.

Future Market Dynamics

Advancements in abuse-deterrent formulations aim to mitigate misuse while maintaining therapeutic effectiveness. Regulatory push for safer opioids could also influence product development and market strategy, shaping the future financial landscape.

Conclusion

The fentanyl hydrochloride market operates within a complex matrix of clinical necessity, regulatory constraints, illicit risks, and evolving innovation. Its financial trajectory appears cautiously optimistic, with sustained demand in medical settings offsetting challenges from regulatory, ethical, and market diversion concerns. Strategic collaborations, technological innovations, and adherence to regulatory standards will be vital for stakeholders seeking sustainable growth in this domain.

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Key Takeaways

• Market Drivers: Growing chronic pain cases, aging populations, and innovations in delivery systems underpin clinical demand for fentanyl hydrochloride.
• Regulatory Impact: Stringent policies to prevent misuse influence manufacturing, distribution, and pricing strategies.
• Illicit Market Influence: The rise of illegal fentanyl significantly impacts legal market perceptions and profitability.
• Pricing Dynamics: Patent expirations and generic competition threaten long-term revenue streams, while emerging formulations offer revenue potential.
• Future Outlook: Market expansion remains steady, with regulatory and technological changes shaping long-term growth.

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FAQs

1. How does the opioid crisis affect the legal fentanyl hydrochloride market?
The opioid epidemic has led to tighter regulations, reducing prescribing practices and increasing scrutiny of supply chains. While demand persists in medical contexts, diversion and misuse concerns limit market flexibility and may inflate regulatory costs.

2. What are the key regulatory challenges facing manufacturers of fentanyl hydrochloride?
Manufacturers must comply with strict scheduling, secure manufacturing protocols, and robust tracking systems to prevent diversion. Regulatory agencies continuously update policies, requiring ongoing compliance investments.

3. How does patent expiration influence the fentanyl hydrochloride market?
Patent expirations enable generic manufacturers to enter the market, increasing competition and generally lowering prices. This can lead to revenue declines for branded products but may broaden access.

4. What role do emerging markets play in the future of fentanyl hydrochloride?
Emerging markets, particularly in Asia and Latin America, are experiencing increasing adoption of opioid analgesics due to expanding healthcare infrastructure. However, regulatory environments and illegal market growth pose both opportunities and risks.

5. Are there innovations that could transform the fentanyl hydrochloride market?
Yes, developments such as abuse-deterrent formulations and alternative delivery methods aim to reduce misuse potential. These innovations could sustain or enhance market growth by addressing safety concerns.

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Sources

[1] Market Research Future, "Opioid Analgesics Market Research Report – Forecast 2027."
[2] U.S. Food and Drug Administration (FDA), "Regulation of Controlled Substances."
[3] European Medicines Agency (EMA), "Standards and Regulations for Opioid Medications."
[4] National Institute on Drug Abuse, "The Opioid Crisis and Fentanyl."
[5] IQVIA, "Global Pain Management Market Analysis," 2022.