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. 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
Patent Applications:	6,840
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
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-007	Oct 30, 1995		DISCN	No	No
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		DISCN	Yes	No			Y
Rising	SUBLIMAZE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	016619-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		DISCN	Yes	No			Y
Specgx Llc	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	078907-005	Oct 30, 2009		DISCN	No	No
Watson Labs	FENTANYL CITRATE	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	079075-003	Jan 7, 2011		DISCN	No	No
Actavis Labs Fl Inc	FENTANYL CITRATE	fentanyl citrate	TABLET;SUBLINGUAL	207338-001	Nov 17, 2017		DISCN	No	No

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	020747-002	Nov 4, 1998
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-003	Oct 4, 1993
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009

International Patents for FENTANYL CITRATE

Country	Patent Number	Title	Estimated Expiration
Argentina	047999	FORMA DE DOSIFICACION ORAL EFERVESCENTE DE FENTANILO Y METODOS DE ADMINISTRACION DE FENTANILO
Argentina	048000	FORMA DE DOSIFICACION ORAL EFERVESCENTE SUBSTANCIALMENTE LINEAL DE FENTANILO Y METODOS DE ADMINISTRACION
Argentina	048029	FORMAS DE DOSIFICACION ORAL EFERVESCENTE DE OPIACEOS Y METODOS DE ADMINISTRACION DE OPIACEOS
Argentina	098347	USO DE DOSIFICACIÓN ORAL EFERVESCENTE DE FENTANILO
Austria	E498395
Austria	E500821
Australia	2004311879	Effervescent oral opiate dosage form

Supplementary Protection Certificates for FENTANYL CITRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; 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
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006

Last updated: July 27, 2026

Fentanyl Citrate market dynamics and financial trajectory: pricing, demand drivers, supply constraints, and profit outlook

Fentanyl citrate is the active pharmaceutical ingredient (API) behind multiple branded and authorized generic opioid products used for cancer pain, breakthrough cancer pain, anesthesia, and procedural analgesia. The commercial trajectory is shaped by (1) persistent U.S. opioid enforcement and prescribing controls, (2) expanding regulatory scrutiny of REMS-like guardrails and diversion risk, (3) supply and manufacturing resilience for high-potency formulations, and (4) reimbursement pressure and payer controls for opioid analgesics. Near-term market growth is constrained by tighter access and litigation risk, while mid-term revenue visibility depends on the lifecycle of specific dosage forms (transmucosal, injectable, and perioperative formulations) and on the competitive balance between originator lines and authorized generics.

The financial profile varies by product line because fentanyl citrate is not a single marketed product. It is sold across multiple dosage forms, each with different demand elasticity, pricing power, and enforcement exposure.

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What drives fentanyl citrate demand and market growth in the US?

Which indications generate the largest recurring demand

• Cancer pain and breakthrough cancer pain: Transmucosal fentanyl products (TIRFs) contribute the highest sensitivity to regulatory controls and prescriber behavior because they are tied to breakthrough episodes rather than baseline pain.
• Anesthesia and perioperative analgesia: Injectable fentanyl citrate demand tracks procedure volumes and hospital anesthesia practices. This segment is less affected by outpatient prescribing restrictions and more influenced by surgical volumes, formulary access, and hospital contracting.

Key demand drivers

• Sustained oncology incidence and pain management protocols: Cancer prevalence and treatment intensity support stable long-term analgesic need.
• Hospital procedure volume: Elective surgery rebounds after macro slowdowns can lift perioperative fentanyl usage.
• Formulary and substitution rules: Payer and hospital formulary decisions influence share between branded products and authorized generics.

Key demand constraints

• Opioid prescribing controls: State-level limits, chronic pain guidelines, and payer utilization management reduce “new start” and may shift volume toward lower-risk pathways.
• Diversion and misuse enforcement: Increased scrutiny around controlled substances affects distribution risk, inventory holding patterns, and compliance costs.

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How do opioid enforcement and regulatory scrutiny affect fentanyl citrate sales?

What is the commercial impact of diversion and misuse focus

• Higher compliance cost: Manufacturers and distributors incur costs tied to controlled substance reporting, audit readiness, and security upgrades.
• Distribution volatility: When enforcement intensifies, wholesalers may shorten order cycles or adjust allocations, affecting quarterly revenue smoothing.
• Product access risk: Any enforcement action that delays supply clearance, triggers recalls, or restricts distribution can produce sudden revenue drawdowns.

How does REMS-style oversight translate to execution risk

Many fentanyl citrate products operate under risk-management expectations tied to overdose prevention, safe use training, and patient selection. Even when the exact structure differs by dosage form, the operational pattern is similar:

• Prescriber training requirements and patient risk stratification increase administrative friction.
• Refill behavior may become more conservative as monitoring intensifies.

What happens to pricing during enforcement cycles

• Branded pricing: Branded fentanyl products often sustain pricing better when protected by exclusivity for a specific formulation, but enforcement cycles can compress net pricing through payer contracting.
• Generics/authorized generics: Authorized generics can reduce average selling price (ASP) in competitive categories, especially when multiple ANDA entrants exist.

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What is the pricing and reimbursement outlook for fentanyl citrate products?

How pricing behaves by dosage form

• Transmucosal fentanyl citrate products: Higher pricing power historically, but net price is sensitive to formulary placement, prior authorization, and step edits.
• Injectables: Competitive pressures and hospital contracting often drive ASP compression; margins depend on manufacturing cost position and contract renewals.

Reimbursement levers that matter

• Medicaid and Medicare Part D contracting: Plans use PA and quantity limits for opioids, which shifts channel volume and reduces monetization per script.
• 340B and hospital purchasing patterns: Hospital segment contracting determines effective net pricing and inventory turns.

Margin drivers

• Manufacturing yield and potency control: Fentanyl is high potency and low-dose volume; manufacturing scrap, contamination control, and stability specifications can shift cost-of-goods sold materially.
• Regulatory compliance spending: Quality system costs and batch release delays can erode margin during periods of operational disruption.

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When does fentanyl citrate lose exclusivity and how does that affect revenue?

Exclusivity is formulation-specific

Revenue risk timing depends on the specific branded product and its protective perimeter:

• patent term expirations for formulation and delivery technology
• pediatric exclusivity (if applicable to the underlying NDA)
• method-of-use patents (in certain lines)
• ANDA approval timelines for generics and authorized generics

Market behavior at generic entry

Typical dynamics for high-control opioid brands:

• Volume share shift quickly after authorized generic availability.
• Net price drops more than demand; utilization often remains stable but revenue declines.
• Manufacturers may respond via contracting concessions, patient support programs, or line extensions in adjacent dosage strengths.

Because fentanyl citrate is a shared API across multiple marketed products, exclusivity loss does not apply uniformly across “fentanyl citrate” as a single asset. The financial trajectory is best modeled as a portfolio of products by dosage form and brand.

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What financial patterns appear in opioid analgesic markets relevant to fentanyl citrate?

Revenue trajectory tends to show three phases

1. Pre-competition steady growth: Branded units expand via oncology pain management and payer acceptance.
2. Managed entry compression: PA tightening, substitution, and authorized generic competition reduce net revenue growth.
3. Mature market plateau with litigation and supply shocks: Revenue stabilizes but is exposed to discrete events (product disruptions, recalls, litigation settlements, or enforcement actions).

What investors typically underwrite

• Net price trend: more important than unit growth once generics compete.
• Channel stability: inventory correction cycles can create quarterly volatility even with stable demand.
• Supply performance: high-potency manufacturing reliability affects the ability to meet contracts and avoid backorders.

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How does fentanyl citrate compare with other opioids in market stability and price pressure?

Compared with oxycodone and hydrocodone

• Transmucosal fentanyl typically faces strong payer utilization management but can sustain differentiated pricing when protected by formulation patents and prescriber familiarity.
• Long-acting oral opioids are subject to broader utilization controls and may see larger volume displacement to alternatives (non-opioid pain management, other opioids with better access).
• Injectable opioids are less exposed to outpatient restrictions but can face hospital formulary switching.

Compared with morphine

Morphine can compete in certain hospital and oncology settings, but fentanyl’s advantage is often tied to rapid onset and perioperative flexibility. Pricing pressure for fentanyl depends on whether a contracting environment favors generic availability.

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Which companies commercialize fentanyl citrate and what does the competitive landscape look like?

Competitive structure

• Branded originator manufacturers: sell protected products across specific dosage forms and strengths.
• Generic manufacturers and authorized generics: enter once formulation and method-of-use protections expire, driving margin compression.
• Contract manufacturers: contribute to supply continuity; disruptions can impact revenue through allocation.

How competition changes market share

• When multiple ANDA products are approved, wholesalers gain choice, which usually reduces realized pricing.
• When manufacturing is constrained, premium to supply can temporarily stabilize pricing, but this is episodic.

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What generic entry risks exist for fentanyl citrate products?

Portfolio-level risks

• ANDA proliferation: more entrants increase substitution and reduce branded net revenue.
• Supply chain concentration: if generic supply is concentrated, disruptions can create short-term branded leverage, but long-term competition remains structural.
• Regulatory compliance risk for entrants: if generics face quality issues, the market can swing back toward available supply, but the risk profile affects investor confidence.

Paragraph IV and litigation risk relevance

Where product-specific patents exist, Paragraph IV challenges and Hatch-Waxman litigation can delay generic entry or trigger settlement agreements. That affects the revenue cliff timing for the originator and shifts market share to authorized generics in the settlement window.

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What FDA and controlled-substance milestones affect fentanyl citrate commercialization?

FDA pathway effects

• NDA versus ANDA: Branded products face full clinical development and longer launch lead time; generics reduce barriers once protections expire.
• Supplements and reformulations: Life-cycle manufacturing changes can trigger additional review cycles and temporary supply interruptions.

Controlled substance regulatory actions

• Inspection outcomes, diversion enforcement, or distribution restrictions can affect availability and net revenue even without label changes.

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How should a business model fentanyl citrate financial trajectory by scenario?

Base case

• Demand remains stable in oncology breakthrough pain and perioperative use.
• Net pricing gradually declines as generic competition expands.
• Revenue growth is limited by utilization management and payer controls.

Upside scenario

• Branded products retain favorable formulary placement in key accounts.
• Supply reliability improves, preventing allocation losses.
• Less aggressive enforcement cycles reduce channel volatility.

Downside scenario

• Expanded substitution by payers accelerates net price compression.
• Quality events, recalls, or manufacturing bottlenecks reduce filled prescriptions.
• Litigation settlements or generic entry occur earlier than expected for specific dosage forms.

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Timeline model: how to map revenue cliffs for fentanyl citrate product portfolios

Fentanyl citrate revenue should be mapped to product-specific milestones (not API-level milestones). A practical timeline framework is:

1. Exclusivity window (patent expiration + any pediatric or exclusivity periods)
2. Regulatory review timing (ANDA acceptance, approval, and labeling)
3. Launch and substitution phase (authorized generic availability, wholesaler acceptance)
4. Pricing reset (net price decline and contract repricing)
5. Stabilization (mature generic pricing and volume plateau)

This structure is consistent across high-control opioid analgesics.

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Key Takeaways

• Fentanyl citrate commercial performance is a dosage-form portfolio story, not a single-asset pattern.
• Market growth is constrained by opioid enforcement, prescribing controls, and utilization management, while anesthesia and hospital procedure demand provide stability.
• Financial trajectory is dominated by net pricing compression once authorized generics and ANDA competition expand.
• Near-term results are sensitive to supply reliability, compliance cost, and discrete regulatory or quality events.
• Revenue cliffs depend on product-specific exclusivity and patent estates, including formulation and method-of-use protections, not the API alone.

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FAQs

1) Does fentanyl citrate sales track opioid policy more than oncology demand?

It tracks both: oncology and perioperative demand provide stability, while utilization controls and diversion enforcement drive pricing and access changes.

2) Are transdermal or transmucosal fentanyl citrate formulations more exposed to price erosion?

Transmucosal fentanyl citrate products typically see stronger utilization management and faster net price pressure when generic competition expands.

3) What drives quarterly volatility in fentanyl citrate revenue?

Supply interruptions, wholesaler allocation changes, and contract repricing can create quarter-to-quarter swings even when underlying demand is stable.

4) How does hospital contracting influence fentanyl citrate injectables compared with outpatient products?

Injectables are shaped more by hospital formularies and procedure volumes, while outpatient formulations face PA, quantity limits, and patient monitoring requirements.

5) What is the biggest financial risk: demand loss or margin compression?

For mature or competing categories, margin compression from authorized generics and contracting is usually the larger revenue driver than unit demand collapse.

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References

No sources were cited.