FENTANYL CITRATE - Generic Drug Details

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

Fentanyl citrate is the generic ingredient in nine branded drugs marketed by Adalvo, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Dr Reddys, Rising, Exela Pharma, Btcp Pharma, Dr Reddys Labs Sa, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in twenty-two NDAs. There are four patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fentanyl citrate has one hundred and thirty-five patent family members in thirty-three countries.

There are fifteen drug master file entries for fentanyl citrate. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for FENTANYL CITRATE

International Patents:	135
US Patents:	4
Tradenames:	9
Applicants:	16
NDAs:	22
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	110
Drug Prices:	Drug price trends for FENTANYL CITRATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENTANYL CITRATE
What excipients (inactive ingredients) are in FENTANYL CITRATE?	FENTANYL CITRATE excipients list
DailyMed Link:	FENTANYL CITRATE at DailyMed

See drug prices for FENTANYL CITRATE

Recent Clinical Trials for FENTANYL CITRATE

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

Sponsor	Phase
National Taiwan University Hospital	PHASE4
Benha University	NA
University of Chicago	PHASE1

See all FENTANYL CITRATE clinical trials

Generic filers with tentative approvals for FENTANYL CITRATE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.05MG BASE/ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FENTANYL CITRATE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for FENTANYL CITRATE

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

N02AB	Phenylpiperidine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for FENTANYL CITRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABSTRAL	Sublingual Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	022510	1	2014-06-19
FENTORA	Buccal Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	021947	1	2007-11-13
ACTIQ	Lozenges	fentanyl citrate	0.6 mg	020747		2004-12-20
ACTIQ	Lozenges	fentanyl citrate	0.8 mg, 1.2 mg and 1.6 mg	020747		2004-11-22
ACTIQ	Lozenges	fentanyl citrate	0.2 mg	020747		2004-10-29
ACTIQ	Lozenges	fentanyl citrate	0.4 mg	020747		2004-10-06

US Patents and Regulatory Information for FENTANYL CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	073488-001	Jun 30, 1992		DISCN	No	No
Par Pharm	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	077312-002	Oct 30, 2009		DISCN	No	No
Exela Pharma	FENTANYL CITRATE	fentanyl citrate	SOLUTION;INTRAVENOUS	215870-001	Feb 8, 2023		DISCN	Yes	No
Exela Pharma	FENTANYL CITRATE	fentanyl citrate	SOLUTION;INTRAVENOUS	215870-002	Feb 8, 2023		DISCN	Yes	No
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	Yes	No	7,862,832		Y
Specgx Llc	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	078907-003	Oct 30, 2009		DISCN	No	No
Actavis Labs Fl Inc	FENTANYL CITRATE	fentanyl citrate	TABLET;SUBLINGUAL	207338-003	Nov 17, 2017		DISCN	No	No

Expired US Patents for FENTANYL CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011	8,889,176
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011	6,432,440
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-004	Jul 16, 2009	6,159,498
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011	7,910,132
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011	9,814,705
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011	6,761,910
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-006	Nov 4, 1998	4,671,953

International Patents for FENTANYL CITRATE

Country	Patent Number	Title	Estimated Expiration
South Korea	101329496
Brazil	PI0418228	forma de dosagem, e, métodos de tratamento de dor e de episódios de dor incidente de cáncer, e de preparação de um tablete para administração bucal, gengival ou sublingual de fentanil
Taiwan	201247491	Improved container
Poland	2054031
Hong Kong	1192522	改良型容器 (IMPROVED CONTAINER)
Taiwan	200611686	Effervescent oral opiate dosage forms and methods of administering opiates
Canada	2549642	FORMES GALENIQUES D'OPIATES ORALES EFFERVESCENTES ET PROCEDES D'ADMINISTRATION D'OPIATES (EFFERVESCENT ORAL OPIATE DOSAGE FORM)

Supplementary Protection Certificates for FENTANYL CITRATE

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
1635783	CA 2014 00016	Denmark		PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783	C300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906

Market Dynamics and Financial Trajectory for Fentanyl Citrate

Last updated: July 28, 2025

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Introduction

Fentanyl citrate, a potent synthetic opioid analgesic, has historically occupied a complex position within the pharmaceutical industry, navigating a landscape characterized by immense therapeutic utility, stringent regulatory oversight, and significant societal implications. Originally developed in the 1960s, fentanyl citrate has cemented its role primarily in hospital settings for acute pain management and anesthesia. However, its high potency—approximately 100 times that of morphine—has precipitated regulatory controls, diversion issues, and burgeoning illicit markets. This article examines the current market dynamics and projected financial trajectory of fentanyl citrate, considering regulatory frameworks, clinical applications, market competition, and recent industry trends.

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Regulatory Environment and Market Constraints

The regulatory landscape significantly influences fentanyl citrate's market potential. Due to its high potency and abuse potential, it is classified under stringent controls by agencies such as the U.S. Drug Enforcement Administration (DEA), the European Medicines Agency (EMA), and equivalent bodies worldwide. In the United States, fentanyl manufacturing and distribution are heavily regulated, requiring license compliance and security measures, constraining supply and elevating production costs.

Recent regulatory actions aim to curtail illicit trafficking. Notably, the DEA's 2018 rescheduling of fentanyl and its analogs into the Schedule II class underscored control intensification. Such measures impact legitimate market supplies, raising barriers to entry and operational costs for pharmaceutical companies. Nonetheless, these controls preserve clinical efficacy by limiting diversion, supporting legitimate demand in monitored healthcare settings.

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Clinical Demand and Therapeutic Landscape

Fentanyl citrate's primary therapeutic use resides in anesthesia and pain management, especially for cancer-related and post-operative pain. Its quick onset and short duration of action make it suitable for invasive procedures. As of 2022, the global opioid analgesics market was valued at approximately USD 12 billion, with fentanyl accounting for a significant share, owing to its potency and efficacy.

Growth factors include:

• Rising prevalence of chronic and acute pain conditions. According to WHO, cancer prevalence increased globally, escalating demand for potent analgesics.
• Advances in anesthesia techniques. The adoption of fentanyl in combination with other agents remains standard practice.
• Aging populations. Elderly demographics worldwide are associated with increased pain treatment needs.

Conversely, the increasing awareness of opioid misuse and overdose risks has prompted tighter prescribing guidelines. The CDC has issued strict opioid prescribing policies, reducing the volume of prescriptions in the U.S. This regulatory shift has tempered growth but has not eliminated demand for legitimate medical use.

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Market Competition and Innovation

The fentanyl market faces competition from other opioid analgesics like morphine, hydromorphone, and newer formulations such as sufentanil and remifentanil, which offer distinct pharmacokinetic advantages. Additionally, non-opioid analgesics, including NSAIDs and adjuvant therapies, are increasingly prescribed to reduce opioid reliance.

Innovation within fentanyl formulations is ongoing, with extended-release patches and transmucosal products offering improved administration routes and patient compliance. Notably:

• Transdermal patches (e.g., Duragesic). These provide sustained analgesia, improving patient adherence.
• Lozenge and buccal films. Designed for rapid onset and ease of administration, especially outside hospital settings.

Pharmaceutical companies invest heavily in these formulations, which often command premium pricing due to advanced delivery systems and clinical benefits. Patent protections on such innovations influence market exclusivity, impacting revenue streams.

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Illicit Market Dynamics and Impact

A critical aspect influencing fentanyl citrate's financial landscape is its illicit counterpart. Fentanyl's clandestine market, largely driven by its potency, has escalated overdose deaths globally. The proliferation of illicit fentanyl—often manufactured illegally in clandestine labs—has led to a crisis, especially in North America, where overdose fatalities involving synthetic opioids surged by over 100% in recent years [1].

This illicit stream has a dual effect:

1. Market distortion: It constrains legitimate sales by creating public health crises and tightening regulations.
2. Pricing and reputation risks: Pharmaceutical companies face scrutiny over supply chain integrity and reputational concerns, prompting heightened compliance measures.

Government interventions, including interdiction and increased surveillance, aim to reduce illicit fentanyl availability, indirectly influencing legitimate market dynamics.

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Financial Trajectory and Investment Outlook

The future financial trajectory of fentanyl citrate hinges on balancing clinical demand with regulatory and societal constraints. Despite regulatory hurdles, a projected CAGR (Compound Annual Growth Rate) of approximately 3-4% is anticipated for the overall fentanyl market over the next five years, primarily driven by emerging markets and expanding indications within pain management [2].

Key factors contributing to this outlook include:

• Growing global analgesics demand. Particularly in emerging economies with expanding healthcare infrastructure.
• Pipeline innovations. New formulations aiming to improve safety profiles and administration methods.
• Regulatory stabilization. Efforts to prevent diversion and illicit use may facilitate more predictable supply chains and market stability.

Major players such as Janssen Pharmaceuticals, Teva Pharmaceuticals, and Mylan continue to develop advanced formulations, maintaining profitability through collaborations and patent protections. Price negotiations, especially in public healthcare systems, may exert downward pressure; nonetheless, premium products and formulations offer revenue flexibility.

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Market Challenges and Risks

The critical risks affecting fentanyl citrate's market and financial trajectory include:

• Regulatory restrictions leading to manufacturing and distribution limitations.
• Societal backlash against opioids manifesting in stricter prescribing guidelines.
• Epidemiological shifts reducing legitimate use owing to concerns about addiction.
• Illicit fentanyl proliferation, which could undermine demand for pharmaceutical-grade fentanyl or lead to legal restrictions on manufacturing inputs.

These challenges necessitate strategic compliance, innovation, and diversification to sustain financial health.

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Conclusion

Fentanyl citrate operates within a tightly regulated, dual-market environment—legitimate medical demand vs. illicit proliferation—that shapes its market dynamics and financial outcomes. Despite constraints, steady growth persists driven by clinical applications, innovation in drug delivery, and expanding healthcare markets. However, societal and regulatory pressures require companies to prioritize safety and compliance, recognizing risks associated with misuse and diversion.

The future financial trajectory is cautiously optimistic, contingent upon navigating regulatory landscapes, combating illicit markets, and advancing therapeutic innovations that enhance safety profiles. Stakeholders should focus on resilient supply chains, diversified formulations, and compliance strategies to capitalize on stabilized growth prospects.

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Key Takeaways

• Regulatory controls significantly influence fentanyl citrate’s market, with stringent licensing and diversion prevention measures increasing operational costs and constraining supply.
• Clinical demand remains robust, especially as global pain management needs grow, but prescribing guidelines’ tightening reflects societal concerns about opioid misuse.
• Innovation in formulations, including transdermal patches and transmucosal products, sustains premium pricing and competitive advantage amid market challenges.
• Illicit fentanyl proliferation hampers legitimate markets but also incentivizes stricter controls and supply chain security investments.
• The projected CAGR of approximately 3-4% over the next five years suggests steady, albeit moderated, growth driven by emerging markets and advanced formulations.

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FAQs

1. How does regulatory scrutiny impact the profitability of fentanyl citrate manufacturing?
Regulatory scrutiny raises compliance costs and restricts supply chains, often leading to higher manufacturing expenses. While these measures ensure safety, they can also limit market entry and volume, impacting profitability. Companies investing in compliance and secure manufacturing processes can mitigate adverse financial effects.

2. What are the main competing products to fentanyl citrate in pain management?
Main competitors include other opioids like morphine, hydromorphone, sufentanil, and non-opioid analgesics such as NSAIDs and adjuvant therapies. Advances in non-opioid pain treatments may also reduce reliance on fentanyl.

3. How does illicit fentanyl production influence the legal pharmaceutical market?
Illicit fentanyl production skews supply and demand, leading to tighter regulations and social backlash. This reduces the market size for legal pharma products and increases costs associated with compliance and diversion prevention.

4. What emerging trends could shape fentanyl citrate’s market over the next decade?
Emerging trends include novel delivery systems (e.g., implantable devices), formulation innovations aiming to reduce abuse potential, and digital health integrations. Furthermore, global healthcare expansion in emerging markets offers long-term growth opportunities.

5. Are there any significant patent expirations expected which could influence fentanyl citrate’s market share?
Yes, patents on specific formulations and delivery systems are expiring periodically, opening opportunities for generic entrants. While this may reduce prices and margins, it also broadens access and could increase overall consumption in non-restricted markets.

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References

[1] Centers for Disease Control and Prevention (CDC). (2022). “Provisional Drug Overdose Death Counts.”
[2] Grand View Research. (2022). “Opioid Analgesics Market Size, Share & Trends Analysis Report.”