Fentanyl citrate - Generic Drug Details

What are the generic sources for fentanyl citrate and what is the scope of freedom to operate?

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. Six 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:	6
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
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011		DISCN	Yes	No
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011		DISCN	Yes	No	9,731,869		Y
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-002	Oct 4, 1993		DISCN	No	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011		DISCN	Yes	No
Exela Pharma	FENTANYL CITRATE	fentanyl citrate	SOLUTION;INTRAVENOUS	215870-001	Feb 8, 2023		DISCN	Yes	No
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006		DISCN	Yes	No	7,862,833		Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		DISCN	Yes	No	7,862,833		Y

Expired US Patents for fentanyl citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-001	Nov 4, 1998	5,785,989
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011	6,761,910
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-003	Dec 21, 2015	9,814,705
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-003	Nov 4, 1998	4,671,953
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006	6,974,590
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-001	Jan 7, 2011	6,761,910
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-003	Oct 4, 1993	4,671,953

International Patents for fentanyl citrate

Country	Patent Number	Title	Estimated Expiration
Japan	2007517054
China	1901890	Generally linear effervescent oral fentanyl dosage form and methods of administering
Norway	20063430
Israel	196529	בופרנורפין לשימוש בהכנת תכשיר רוקחי להגרת הספיגה מחדש של בופרנורפין וכהתקן לשחרור תרופה מתכלה מוקואדהסיבי (Buprenorphine for use in the preparation of a pharmaceutical composition for providing enhanced uptake of buprenorphine and mucoadhesive bioerodable drug delivery device based thereon)
Japan	5244318
Taiwan	201247491	Improved container
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
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	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
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
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: February 20, 2026

What is the Global Market Size and Growth Trend for Fentanyl Citrate?

The global market for fentanyl, including fentanyl citrate formulations, is expanding due to rising demand in pain management and anesthesia. The market was valued at approximately USD 3.7 billion in 2021, with projections reaching USD 6.0 billion by 2028, reflecting a compound annual growth rate (CAGR) of around 7.2% from 2022 to 2028 (Grand View Research, 2022). This growth is driven by increased application in hospital settings and outpatient procedures.

Fentanyl citrate accounts for about 40% of the total fentanyl market, primarily used in injectable, transdermal, and lozenge formulations. The U.S. dominates the regional market, with North America capturing roughly 65% of global sales, driven by high opioid prescription rates and advanced healthcare infrastructure.

How Do Regulatory and Ethical Factors Influence Market Dynamics?

Regulatory controls significantly shape the fentanyl citrate market. The drug is classified as a Schedule II controlled substance under the U.S. Controlled Substances Act. Globally, similar legislative restrictions limit production, distribution, and prescribing, impacting supply chains and market accessibility.

Increased awareness of opioid abuse and the rise in illicit fentanyl trafficking pose regulatory challenges. Governments implement stricter controls on manufacturing and distribution, with some countries enforcing tighter import/export restrictions and surveillance.

Despite restrictions, legitimate demand persists in medical contexts, particularly in acute pain management and anesthesia during surgeries. The evolving regulatory landscape balances clinical necessity with risks of misuse, influencing the development of abuse-deterrent formulations.

What Are the Key Market Segments and Their Financial Contributions?

The fentanyl citrate market segments into formulation types, applications, and end-users:

• Formulation Types:

  • Injectable (approx. 50% of sales): used primarily in hospitals for anesthesia.
  • Transdermal patches (approx. 35%): prescribed for chronic pain.
  • Lozenges and buccal formulations (approx. 15%): used in palliative care.

• Applications:

  • Surgical anesthesia (approx. 45%)
  • Chronic pain management (approx. 40%)
  • Breakthrough pain in cancer patients (approx. 15%)

• End-Users:

  • Hospitals and clinics (about 72%)
  • Outpatient care centers (about 20%)
  • Research and pharmaceutical manufacturing (approx. 8%)

The hospital and clinical segment is the largest contributor to revenue, reflecting high-volume use in surgical procedures and acute care.

What Are the Main Drivers and Restraints Impacting Market Growth?

Drivers:

• Increased demand for potent analgesics to treat severe pain.
• Growing acceptance of fentanyl formulations in anesthesia.
• Advances in delivery systems, including patch technology and rapid-onset formulations.
• Global demographic shifts toward aging populations with chronic pain conditions.

Restraints:

• Regulatory restrictions and monitoring impede production and distribution.
• Risks of misuse, addiction, and overdose lead to legal and ethical constraints.
• Public and governmental efforts to curb opioid epidemic impact legal prescriptions.
• Competition from non-opioid analgesics and abuse-deterrent formulations.

How Do Patent Trends and Innovation Influence Market Competition?

Patent protections influence market exclusivity and pricing. Major pharmaceutical companies hold patents for fentanyl citrate formulations, delaying generic entry. Yet, patent expirations have begun, increasing generic competition and lowering prices.

Innovations focus on abuse-deterrent systems, such as formulations resistant to crushing or dissolving. These developments aim to reduce misuse but face regulatory hurdles and higher R&D costs. Emerging delivery modalities, including sublingual and nasal sprays, expand therapeutic options.

What Is the Financial Outlook and Investment Potential?

The fentanyl citrate market exhibits steady growth with attractive profit margins driven by high potency and premium pricing of novel formulations. Major players like Johnson & Johnson, Teva Pharmaceuticals, and Mylan generate significant revenue from fentanyl-based products.

Market investments target development of abuse-deterrent formulations, transdermal patches with improved efficacy, and formulations for specific patient populations. Risks include regulatory crackdowns, legal liabilities, and the ongoing opioid overdose crisis.

Given the current market size and growth rate, the sector holds significant investment interest, especially for companies capable of navigating legislative complexities and developing safer delivery systems.

Key Takeaways

• The global fentanyl market, including fentanyl citrate, was valued at USD 3.7 billion in 2021, projected to reach USD 6 billion by 2028.
• North America dominates the market, with hospital formulations as the primary revenue driver.
• Regulatory restrictions significantly impact supply, development, and marketing strategies.
• Patent cycles and innovations in abuse-deterrent systems influence competitive positioning.
• The market presents growth opportunities in novel formulations and specialized delivery methods, despite regulatory and misuse risks.

FAQs

1. How does regulatory oversight affect fentanyl citrate sales?
Regulations restrict manufacturing, prescribing, and distribution, impacting supply chains and market volume. Stringent monitoring aims to prevent misuse but can limit legitimate medical access.

2. What is the outlook for generic versions of fentanyl citrate?
Patent expirations have led to increased generic availability, pressuring brand-name pricing and margins. Generics improve access but heighten competition.

3. Are there concerns about market saturation?
High demand persists due to clinical essentiality. However, increased regulation, abuse concerns, and competition from non-opioid analgesics may restrain growth prospects.

4. Which innovations could reshape the fentanyl citrate market?
Abuse-deterrent formulations, advanced transdermal patches, and rapid-onset delivery systems aim to reduce misuse while expanding therapeutic options.

5. What is the risk profile for investment in fentanyl citrate products?
Regulatory risks, legal liabilities, and societal pressures associated with the opioid epidemic pose significant challenges. Market growth depends on successful development of safer formulations.

References

1. Grand View Research. (2022). Fentanyl market size, share & trends analysis report. https://www.grandviewresearch.com/industry-analysis/fentanyl-market