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:	1,913
DailyMed Link:	FENTANYL HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FENTANYL HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

9,364,656

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
dilara gocmen	NA

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	9,364,656
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	8,428,708
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	9,731,121		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	6,216,033
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006	6,975,902
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006	5,232,438

International Patents for FENTANYL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Israel	228162	מכשיר להעברה חשמלית בעל שני חלקים (Two-part electrotransport device)
Japan	5813856
South Korea	20150022879	SELF-TEST FOR ANALGESIC PRODUCT

Supplementary Protection Certificates for FENTANYL HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124

Market Dynamics and Financial Trajectory for Fentanyl Hydrochloride

Last updated: February 20, 2026

Fentanyl hydrochloride is a potent synthetic opioid analgesic used mainly for pain management, anesthesia, and certain chronic pain conditions. As a Schedule II controlled substance, its commercial and regulatory landscape are tightly regulated, influencing market growth, research activity, and revenue streams.

Market Size and Growth Drivers

Global demand for fentanyl hydrochloride predominantly stems from hospitalization, perioperative care, and pain management in palliative settings. The global opioid analgesics market was valued at approximately USD 11.2 billion in 2022 [1]. Fentanyl constitutes a significant share, driven by its potency and rapid onset of action.

Key Drivers:

• Surge in orthopedic and oncologic surgeries increases demand.
• Rising prevalence of chronic and terminal illnesses.
• Adoption of advanced delivery systems like transdermal patches and lozenges.
• Growing use in anesthesia procedures.

Market Constraints:

• Strict regulatory controls limiting manufacturing and distribution.
• Rising awareness of opioid addiction risks reducing prescription practices.
• Legal and ethical debates impacting market expansion.

Regulatory and Patent Landscape

Fentanyl's regulation varies globally:

• In the U.S., it is classified as a Schedule II drug.
• The European Union imposes similar controls with strict manufacturing standards.

Patent hurdles exist primarily for novel delivery forms and formulations. Existing patents on formulations like fentanyl patches are nearing expiration, opening opportunities for generic manufacturers.

Patent Timeline:

Patent Type	Expiry Year	Remarks
Formulation patents (e.g., patches)	2024-2028	Generics entering early 2020s.
Delivery system patents	2026-2030	Some exclusive rights still valid.

Commercial Players and Market Share

Leading pharmaceutical companies include Johnson & Johnson (Duragesic patch), Teva Pharmaceuticals, and Sandoz. The market share is heavily concentrated with top players controlling approximately 70% of sales, primarily from patented formulations.

Market Share Distribution:

Company	Market Share	Key Products
Johnson & Johnson	40%	Duragesic, Sublimaze
Teva Pharmaceuticals	20%	Generic fentanyl patches
Sandoz	10%	Generic fentanyl formulations

Research and Development Trends

Major R&D efforts are focusing on:

• Non-invasive delivery systems (e.g., buccal films).
• Abuse-deterrent formulations.
• Reduced addiction potential.

Investment in these areas is projected to reach USD 500 million annually over the next five years [2].

Financial Trajectory

Revenue fluctuations are tied to patent expiries and regulatory changes. The global fentanyl market alone is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2028 [1].

Revenue Projections:

Year	Market Revenue (USD billion)	Growth Rate
2023	11.2	—
2025	12.8	4.7% CAGR
2028	14.8	4.5% CAGR

Generic entrants post-patent expiry may reduce prices, impacting revenues for branded products.

Outlook Summary:

• Short-term growth driven by ongoing surgeries and pain management.
• Post-patent expiry, a decline in brand premium sales.
• R&D investments aim to mitigate market share erosion by innovating safer, abuse-deterrent products.

Key Risks and Opportunities

Risks:

• Increased regulation and tighter prescribing controls.
• Litigation and legal restrictions related to opioid abuse.
• Market saturation with generics.

Opportunities:

• Development of non-addictive formulations.
• Expansion into emerging markets with rising healthcare infrastructure.
• Innovative delivery systems increasing patient compliance.

Key Takeaways

• The fentanyl hydrochloride market is mature with considerable growth potential in specialized forms and regions.
• Patent expiries are set to drive generics, exerting downward pressure on prices.
• R&D targeting abuse-deterrent and non-invasive delivery systems represents a critical growth area.
• Regulatory environment tightly constrains supply chains and market access.
• The global market is projected to expand at around 4.5% CAGR through 2028.

Frequently Asked Questions

1. How do patent expiries affect the fentanyl hydrochloride market?
Patent expiries allow generic manufacturers to enter the market, increasing supply and decreasing prices, which can reduce revenues from branded formulations.

2. What are the main regulatory challenges for fentanyl hydrochloride?
Stringent controls on manufacturing, distribution, and prescribing limit market access. Legal restrictions aim to prevent misuse but increase compliance costs.

3. Are there innovative products in development?
Yes. R&D focuses on abuse-deterrent formulations, non-invasive delivery systems, and formulations with lower addiction potential.

4. How significant is the geographic variation in the market?
Regulatory strictness and healthcare infrastructure variability influence regional sales. North America dominates due to high opioid utilization; emerging markets are expanding.

5. What is the outlook for generics post-patent expiry?
Market share shifts to generics, which exert pricing pressures but expand access. Revenue from branded drugs declines accordingly.

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References

[1] MarketsandMarkets. (2022). Opioid analgesics market by drug class and region.
[2] IBISWorld. (2023). Pharmaceutical research and development in pain management.