FENTANYL - Generic Drug Details

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

Fentanyl is the generic ingredient in twenty-five branded drugs marketed by Janssen Pharms, Actavis Labs Ut Inc, Difgen Pharms, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, Zydus Pharms, Btcp Pharma, Adalvo, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Dr Reddys, Rising, Exela Pharma, Dr Reddys Labs Sa, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and The Medicines Co, and is included in thirty-four NDAs. There are twenty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fentanyl has thirty-three patent family members in seventeen countries.

There are thirty-one drug master file entries for fentanyl. Five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for FENTANYL

International Patents:	33
US Patents:	21
Tradenames:	25
Applicants:	26
NDAs:	34
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	1,913
Patent Applications:	7,384
Drug Prices:	Drug price trends for FENTANYL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENTANYL
What excipients (inactive ingredients) are in FENTANYL?	FENTANYL excipients list
DailyMed Link:	FENTANYL at DailyMed

See drug prices for FENTANYL

See drug sales revenues for FENTANYL

Recent Clinical Trials for FENTANYL

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

Sponsor	Phase
Christopher D. Verrico	PHASE1
Baylor College of Medicine	PHASE1
Istanbul University - Cerrahpasa	NA

See all FENTANYL clinical trials

Generic filers with tentative approvals for FENTANYL

Applicant	Application No.	Strength	Dosage Form
		EQ 0.05MG BASE/ML	INJECTABLE;INJECTION
		800MCG	TABLET;BUCCAL
		600MCG	TABLET;BUCCAL

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

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for FENTANYL

Adjuvants, Anesthesia

Analgesics, Opioid

Anesthetics, Intravenous

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for FENTANYL

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUBSYS	Sublingual Spray	fentanyl	0.1 mg/spray, 0.2 mg/spray, 0.6 mg/spray, 0.8 mg/spray, 1.2 mg/spray, 1.6 mg/spray	202788	1	2017-12-07
SUBSYS	Sublingual Spray	fentanyl	0.4 mg/spray	202788	1	2017-05-22

US Patents and Regulatory Information for FENTANYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	077312-002	Oct 30, 2009		DISCN	No	No
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-002	Oct 4, 1993		DISCN	No	No
Actavis Labs Ut Inc	FENTANYL-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076709-004	Aug 20, 2007		DISCN	No	No
Mayne Pharma	FENTANYL-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077062-004	Aug 20, 2007		DISCN	No	No
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-002	Jan 4, 2012		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006		DISCN	Yes	No			Y

Expired US Patents for FENTANYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990
Janssen Pharms	DURAGESIC-75	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-002	Aug 7, 1990
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990
Janssen Pharms	DURAGESIC-100	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-001	Aug 7, 1990

EU/EMA Drug Approvals for FENTANYL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	PecFent	fentanyl	EMEA/H/C/001164PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.	Authorised	no	no	no	2010-08-31
Takeda Pharma A/S	Instanyl	fentanyl	EMEA/H/C/000959Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.	Authorised	no	no	no	2009-07-20
Teva B.V.	Effentora	fentanyl	EMEA/H/C/000833Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain., , BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,	Authorised	no	no	no	2008-04-04
Incline Therapeutics Europe Ltd	Ionsys	fentanyl	EMEA/H/C/002715Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.	Withdrawn	no	no	no	2015-11-18
Eli Lilly and Company Limited	Recuvyra	fentanyl	EMEA/V/C/002239For the control of pain associated with orthopaedic and soft tissue surgery in dogs.	Withdrawn	no	no	no	2011-10-06
Janssen-Cilag International NV	Ionsys	fentanyl	EMEA/H/C/000612Management of acute moderate to severe post-operative pain for use in a hospital setting only	Withdrawn	no	no	no	2006-01-24	2008-07-25

International Patents for FENTANYL

Country	Patent Number	Title	Estimated Expiration
Australia	2007208229	Sublingual fentanyl spray
Brazil	PI0707235	formulação de fentanil sublingual, dose unitária de uma formulação de fentanil sublingual, métodos para tratar dor e para tratar a manifestação súbita da dor, dispositivos de dose unitária ou dose dupla e de dose múltipla para a administração sublingual de um medicamento, método para preparar uma composição farmacêutica para a administração sublingual, formulação farmacêutica sublingual, dose unitária de uma formulação farmacêutica sublingual, e, método para tratar um paciente humano
Canada	2637672	PULVERISATION SUBLINGUALE DE FENTANYLE (SUBLINGUAL FENTANYL SPRAY)
China	101378735	Sublingual fentanyl spray
Cyprus	1117263
Denmark	1976521
European Patent Office	1976521	Pulvérisation sublinguale de fentanyle (Sublingual fentanyl spray)

Supplementary Protection Certificates for FENTANYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124

Fentanyl Drug Market Dynamics and Financial Trajectory (Revenue Mix, Pricing Drivers, and Access Constraints)

Last updated: June 8, 2026

Fentanyl revenue is driven by (1) the scale of chronic and acute pain prescribing, (2) market access and payer restrictions for higher-strength opioid formulations, (3) the mix shift between immediate-release, extended-release, and transdermal delivery, and (4) regulatory and litigation overhang affecting brand continuity, distribution, and insurer controls. Financial trajectory is volatile due to opioid-industry risk, but demand remains structurally supported by persistent pain-care and surgical/anesthesia use.

How big is the fentanyl market and what are the key revenue drivers?

Direct answer: Fentanyl is a high-volume opioid across hospital and community settings. Financial results tend to track prescription volume and unit intensity by product type (transdermal, oral transmucosal, injectable) and by payer steering after safety-focused restrictions.

What sub-markets account for most sales (injectables, transdermal, oral transmucosal, oral)?

Fentanyl is marketed in multiple delivery forms that map to distinct commercial dynamics:

• Injectable fentanyl (IV/IM/other hospital use): Revenue tracks surgical volumes, procedural sedations, anesthesia protocols, and hospital formulary decisions.
• Transdermal fentanyl patches: Revenue depends on chronic pain population, dose titration, payer policies, and substitution rules among patch brands/generics.
• Oral transmucosal fentanyl (OTFC) for breakthrough cancer pain (notably with REMS): Revenue depends on oncology incidence, cancer pain management adoption, insurer authorization, and REMS compliance.
• Oral fentanyl products (where marketed): Revenue depends on patient conversion, prescriber habits, and generic/authorized generic pressure where applicable.

What pricing factors influence fentanyl financial trajectory?

Fentanyl’s pricing trajectory is shaped by:

• Wholesale acquisition cost and rebate pressure: Mature opioid markets see rebate intensity and payer negotiations, especially where multiple equivalents exist.
• Formulary tiering: Higher restrictions after opioid safety policy updates reduce access for certain schedules and strengths, compressing net pricing.
• Generic and authorized-generic substitution: Where generics are available, brand net sales often decline unless the brand holds distinct segments via delivery technology or access contracts.

What demand drivers persist despite opioid headwinds?

• Surgical and anesthesia throughput: Injectable fentanyl remains standard in perioperative care in many settings.
• Cancer pain programs: OTFC products align with breakthrough cancer pain treatment pathways where prescribers follow defined criteria.
• Chronic pain management: Transdermal fentanyl supports stable analgesia regimens where titration is appropriate and patient selection is used.

How do regulatory controls and REMS affect fentanyl market access and sales?

Direct answer: REMS-like controls, risk communications, and insurer utilization management reduce misuse risk but also create barriers to patient access and refill continuity, typically slowing growth and increasing churn.

Which regulatory mechanisms have the biggest commercial impact?

• Distribution controls and education requirements for certain fentanyl products, particularly those used for breakthrough pain.
• Prescriber and patient selection requirements that can limit eligible patient pools.
• Pharmacy dispensing limits and documentation workflows that add friction and can reduce adherence.

How do state and payer opioid policies translate into financial outcomes?

Payer and health-system policies shift:

• Formulary placement (preferred opioid lists, prior authorization, step therapy).
• Quantity limits (days supply caps, early refill restrictions).
• Mandatory monitoring (PDMP checks, urine drug monitoring requirements).

These controls typically shift sales from brand to controlled equivalents, depress net-to-gross, and increase market share volatility.

What patent and exclusivity dynamics shape long-term fentanyl brand competitiveness?

Direct answer: Fentanyl’s active ingredient is long off patent for most delivery modalities, so brand survival depends on product-specific formulations, device systems, and controlled distribution rules rather than broad active-ingredient exclusivity.

Do fentanyl products face generic entry risk?

Yes. The risk profile is usually:

• High substitution where multiple products are therapeutically equivalent
• Lower brand stability where delivery systems have narrow switching and REMS workflow integration

What is the practical “IP barrier” for new entrants?

Where active ingredient patents are gone, barriers shift to:

• Device/formulation performance (bioavailability, stability, dosing accuracy)
• Regulatory pathway choices (505(b)(2) vs ANDA)
• Litigation history tied to specific products, not fentanyl itself

Which fentanyl formulations are most exposed to market share erosion from generics?

Direct answer: Formulations with many authorized equivalents and straightforward bioequivalence submissions are most exposed. Branded advantage is strongest where delivery technology and patient onboarding under controlled systems make switching operationally costly.

Transdermal fentanyl patch: what drives switching and price compression?

• Patch markets often see substitution quickly once equivalents are established.
• Net price erosion follows increased competition and payer steering.

Oral transmucosal fentanyl (OTFC): why can it hold up better?

• OTFC products require strict patient eligibility criteria.
• REMS and oncology prescribing patterns slow conversion to substitutes.

Injectable fentanyl: how does procurement affect finances?

• Hospital tendering and contracting can drive rapid share swings by supplier price and supply reliability.
• Supply continuity and manufacturing scale are critical to avoiding lost procurement.

How does fentanyl supply chain risk influence financial trajectory and continuity of sales?

Direct answer: Fentanyl’s commercial performance can be disrupted by manufacturing constraints, regulatory inspections, and supply interruptions, especially for controlled products with complex distribution.

What operational risks matter most commercially?

• Sourcing bottlenecks for key intermediates and finished dose manufacturing
• Batch release delays and short-dated inventory
• Regulatory actions (facility warnings, consent decrees) that pause distribution

Supply shocks can shift revenue between quarters and between channel inventories.

How does fentanyl pricing compare across delivery systems (patch vs OTFC vs injectable)?

Direct answer: Injectable and hospital channel sales generally reflect negotiated hospital procurement and tender pricing. Transdermal and OTFC are more sensitive to outpatient payer rules and patient eligibility workflows.

What typical pricing patterns are seen by payer segment?

• Hospital: contract-driven pricing, lower variability by patient access.
• Outpatient: higher net-to-gross volatility from prior authorization and copay design.
• Oncology-related breakthrough: higher administrative overhead and payer scrutiny, which can dampen volume.

What litigation and opioid-industry settlements affect fentanyl brand outcomes?

Direct answer: Litigation around opioid sales and marketing conduct has broad industry-level effects that can pressure pricing, restrict marketing approaches, and influence payer behavior. Individual product performance can diverge depending on historical conduct, distribution practices, and settlement terms.

How do settlements typically show up in financial reporting?

• One-time charges and ongoing royalty or settlement payments
• Higher compliance costs and changes in commercial execution
• Higher insurer and health-system scrutiny that can reduce demand

What is the competitive landscape for fentanyl products (brands vs generics vs authorized generics)?

Direct answer: Competitive intensity is highest in transdermal patches and many injectable equivalents, where therapeutic substitution is easier. Competitive intensity is moderated in OTFC where REMS workflows and strict indications constrain switching speed.

How does competition affect revenue stability?

• Brand units decline faster when payers steer to lower-cost equivalents without friction.
• Brand revenue may remain resilient where the brand has entrenched dosing protocols, access agreements, and onboarding systems.

When does fentanyl lose exclusivity by product lifecycle stage?

Direct answer: For most fentanyl products, exclusivity is past for the active ingredient. The practical “loss of exclusivity” is driven by:

1. entry of generic therapeutically equivalent products, and
2. replacement of branded products due to payer controls and formulary changes.

How do lifecycle events show up in financials?

• Pre-generic ramp: brand revenue often peaks with maximized access.
• Post-generic drop: volume declines and net pricing falls quickly.
• Stabilization: occurs when remaining patients are controlled by eligibility criteria or where the brand is retained by institutional protocols.

What generic entry risks exist for fentanyl products under FDA pathways?

Direct answer: Generic risk is ongoing for fentanyl delivery forms that support ANDA approval and can meet bioequivalence. For products with stricter controlled-use requirements, generic entry can still occur but adoption can be slower.

What adoption barriers delay generic conversion?

• patient eligibility screening requirements
• REMS enrollment and prescriber workflow integration
• payer authorization rules

What does fentanyl revenue mix imply for the financial trajectory outlook?

Direct answer: Revenue trajectory is likely to remain supported by inpatient procedure volume and stable chronic pain demand, while experiencing periodic outpatient volume shocks from access restrictions, substitution, and supply events.

Scenario map: drivers by revenue line

• Injectables: steadier demand; sensitive to hospital contracting and supply reliability.
• Patches: downward pressure from substitution and rebate negotiation; moderate stability if prescribers remain loyal and payer step therapy is not strict.
• OTFC: volume can be more stable but is exposed to REMS-administration friction and oncology payer controls.

Key takeaways

• Fentanyl financial performance is driven more by delivery-form mix, outpatient access controls, and supply continuity than by active-ingredient exclusivity.
• Generic and authorized-generic substitution compresses net pricing, especially in transdermal and many hospital-facing segments.
• REMS-like controls and patient eligibility rules moderate substitution speed for breakthrough formulations but also reduce accessible patient pools.
• Litigation and opioid-policy impacts show up through compliance costs, payer steering, and demand friction rather than through a single product-level patent event.
• Net sales trajectory tends to be volatile quarter-to-quarter due to supply and formulary shifts, with outpatient segments typically more sensitive than hospital procurement.

FAQs

1. Which fentanyl delivery form is most exposed to payer-driven substitution and price erosion?
2. How do REMS and patient eligibility rules change fentanyl outpatient utilization patterns?
3. What operational factors most often disrupt fentanyl supply and can swing revenue between quarters?
4. How does hospital contracting for injectable fentanyl affect unit volume versus net pricing?
5. What settlement and compliance costs most commonly appear in financial statements for fentanyl marketers?

References

1. FDA. REMS overview and enforcement resources. U.S. Food and Drug Administration website. (Accessed 2026-06-08).
2. FDA. Drug approvals and labeling resources for fentanyl products. U.S. Food and Drug Administration website. (Accessed 2026-06-08).
3. Orange Book (FDA). Fentanyl active ingredient and product listing records. U.S. FDA Orange Book. (Accessed 2026-06-08).