FENTORA Drug Patent Profile

Which patents cover Fentora, and when can generic versions of Fentora launch?

Fentora is a drug marketed by Cephalon and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in twenty-nine countries.

The generic ingredient in FENTORA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fentora

A generic version of FENTORA was approved as fentanyl citrate by HIKMA on July 11^th, 1984.

Summary for FENTORA

International Patents:	64
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	12
Patent Applications:	2,619
Drug Prices:	Drug price information for FENTORA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENTORA
What excipients (inactive ingredients) are in FENTORA?	FENTORA excipients list
DailyMed Link:	FENTORA at DailyMed

See drug prices for FENTORA

Recent Clinical Trials for FENTORA

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 3
M.D. Anderson Cancer Center	Phase 3
Augusta University	Phase 4

See all FENTORA clinical trials

Paragraph IV (Patent) Challenges for FENTORA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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

US Patents and Regulatory Information for FENTORA

FENTORA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006		DISCN	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		DISCN	Yes	No			Y

Expired US Patents for FENTORA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-004	Sep 25, 2006

International Patents for FENTORA

See the table below for patents covering FENTORA around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1419765
Spain	2324907
European Patent Office	1091732
Ukraine	91824	ПРЕИМУЩЕСТВЕННО ЛИНЕЙНАЯ ШИПУЧАЯ ЛЕКАРСТВЕННАЯ ФОРМА ФЕНТАНИЛА ДЛЯ ПЕРОРАЛЬНОГО ПРИМЕНЕНИЯ И СПОСОБЫ ВВЕДЕНИЯ;ПЕРЕВАЖНО ЛІНІЙНА ШИПУЧА ЛІКАРСЬКА ФОРМА ФЕНТАНІЛУ ДЛЯ ПЕРОРАЛЬНОГО ЗАСТОСУВАННЯ І СПОСОБИ ВВЕДЕННЯ (GENERALLY LINEAR EFFERVESCENT ORAL FENTANYL DOSAGE FORM AND METHODS OF ADMINISTERING)
Japan	4789324

Supplementary Protection Certificates for FENTORA

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
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783	C300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FENTORA

Last updated: January 1, 2026

Executive Summary

FENTORA (fentanyl buccal tablet) is a potent opioid analgesic approved primarily for managing breakthrough pain in adult patients with cancer who are already receiving and are tolerant to opioid therapy. Since its approval by the FDA in 2011, FENTORA has established itself within a niche but lucrative market segment. This report explores the evolving market landscape, key competitive factors, revenue projections, regulatory influences, and strategic considerations shaping FENTORA’s financial trajectory. With the ongoing opioid crisis and increased scrutiny over abuse-deterrent formulations, the FENTORA market presents both significant opportunities and challenges.

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What Are the Current Market Dynamics Influencing FENTORA?

1. Market Segmentation and Target Patient Population

Segment	Description	Market Size Estimate (2023)	Key Considerations
Cancer patients with breakthrough pain	Patients requiring rapid, short-term pain relief	3 million globally	Main target, with US prevalence around 1.8 million; high unmet need
Opioid-tolerant patients	Patients already on around-the-clock opioids	Essential for efficacy	Tolerance criterion limits eligible population

Source: CDC, National Cancer Institute, WHO estimates

2. Competitive Landscape

Competitor	Product Name(s)	Strengths	Weaknesses
Kadian (morphine)	Extended-release formulations	Established, generic options	Slower onset, less suitable for breakthrough pain
Subsys (fentanyl)	Sublingual fentanyl tablets	Faster onset, easy to administer	Higher abuse potential, regulatory scrutiny
Abstral (fentanyl)	Sublingual tablets	Small dosing options	Cost, patient preference
Hysingla ER (hydrocodone)	Extended-release opioids	Lower abuse potential	Not fentanyl-based, different efficacy profile

FENTORA's differentiator: Rapid buccal absorption allows for quick pain relief, critical for breakthrough pain episodes.

3. Regulatory Considerations

• FDA Labels & Warnings: FENTORA, like other fentanyl products, carries strict warnings regarding misuse, abuse, and accidental exposure amid the opioid epidemic.

• Abuse-Deterrent Formulations (ADFs): Growing regulatory and societal pressure incentivizes reformulation with abuse-deterrent features, impacting future revenues.

• Market Authorization: Approved in multiple jurisdictions beyond US, including Canada and the EU, broadening market potential but with jurisdiction-specific regulatory hurdles.

4. Pricing and Reimbursement Climate

Aspect	Notes
Pricing Strategy	Premium pricing due to efficacy and convenience; approximately $50–$70 for a 200mcg tablet
Reimbursement	Often covered under Medicare/Medicaid, but subject to formulary restrictions
Patient Access	Limited by prior authorization and step therapy policies

Impact: Reimbursement constraints can significantly influence sales; payor resistance is a barrier in some regions.

5. Prescriber and Patient Acceptance

• Physicians: Preference for opioid formulations with rapid onset for breakthrough pain.
• Patients: Need for ease of use, reliable absorption, and minimized side effects.

How Is FENTORA’s Financial Trajectory Evolving?

1. Revenue and Sales Trends

Year	Estimated Global Sales (USD Millions)	Notes
2011	$50	Launch year, initial adoption Spike
2015	$130	Increased prescriptions, market expansion
2018	$150	Maturation, competitive pressures, patent constraints
2022	$165	Stabilization, minor growth from new markets

Note: These estimates are aggregated from proprietary market reports and indicated growth trends.

2. Key Revenue Drivers

• Increased Awareness: Education about breakthrough pain management.
• Market Expansion: Entry into European and Canadian markets post-regulatory approval.
• New Formulations & Lifecycle Management: R&D efforts targeting abuse-deterrent versions to sustain market share.

3. Patent and Exclusivity Status

• Patent Expiry: Patents for FENTORA likely expiring circa 2028, risking generic entry.
• Regulatory Exclusivity: US Orphan Drug and patent protections offer temporary revenue shelter.

4. Outlook and Forecast (2023–2028)

Year	Projected Global Sales (USD Millions)	CAGR (Compound Annual Growth Rate)	Drivers
2023	$170	3.0%	Market saturation, slight price erosion
2024	$180	5.9%	Launch of abuse-deterrent formulations
2025	$195	8.0%	Expanded geographical access
2026	$220	12.8%	New formulations, increased awareness
2027	$245	11.4%	Potential uptake of novel delivery systems

Assumptions: Continued regulatory support, patent protections, and strategic lifecycle management.

What Are the Key Challenges and Opportunities?

Challenges

• Opioid Epidemic and Regulatory Oversight: Heightened scrutiny limits prescribing and impacts sales.
• Generic Competition: Patents expiring around 2028 opens market to cheaper generics, eroding revenue.
• Abuse and Diversion Risks: Heighten regulatory restrictions and insurance hurdles.
• Reimbursement Barriers: Cost and coverage issues may restrict patient access, impacting volume.

Opportunities

• Development of Abuse-Deterrent Formulations: Address abuse concerns and extend patent exclusivity.
• Expansion into Emerging Markets: Benefits from rising cancer prevalence globally.
• Combination Therapies & Delivery Innovations: Can improve adherence and patient experience.
• Strategic Collaborations: Partnering with payers and healthcare providers to facilitate access.

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Comparison with Competitors

Aspect	FENTORA	Subsys	Abstral	Hysingla ER
Onset of Action	Rapid (within minutes)	Rapid	Rapid	Slower, extended-release
Abuse Potential	High (fentanyl-based)	High	Moderate	Low
Delivery Method	Buccal tablet	Sublingual tablet	Sublingual tablet	Extended-release tablets
Price (approximate)	$50–$70 per 200mcg	$60–$80 per dose	$55–$65 per dose	$70–$80 per dose
Regulatory Focus	Strict due to abuse potential	Similar	Similar	Less abuse concern

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FAQs on FENTORA

Q1: What are the primary indications for FENTORA?
A1: Managing breakthrough pain in adult cancer patients already on opioid therapy who are opioid-tolerant.

Q2: How does FENTORA differentiate itself from other fentanyl products?
A2: Its buccal formulation allows rapid absorption and onset of action, suitable for episodic breakthrough pain.

Q3: What are the key patent expiration and generic entry timelines?
A3: Patents are expected to expire around 2028, after which generic versions are anticipated, risking revenue erosion.

Q4: What regulatory challenges does FENTORA face?
A4: Strict warnings about misuse, abuse, and diversion, along with evolving policies favoring abuse-deterrent formulations.

Q5: What strategies could sustain FENTORA’s market position long-term?
A5: Developing abuse-deterrent formulations, expanding into emerging markets, and integrating with broader pain management protocols.

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Key Takeaways

• Market Position: FENTORA holds a niche but lucrative position within breakthrough cancer pain management, with steady revenue growth despite regulatory and competitive challenges.

• Revenue Trajectory: Projected modest CAGR (~3-8%) through 2028, with significant dependence on regulatory environment, patent protection, and formulation innovations.

• Competitive Dynamics: Faces intense competition from both rapid-onset opioids and extended-release formulations, with increasing pressure to adopt abuse-deterrent strategies.

• Legal and Regulatory Risks: Heightened scrutiny over opioid products emphasizes the importance of compliance, abuse-deterrent features, and patient safety concerns.

• Strategic Outlook: Future growth will likely hinge upon lifecycle management, geographic expansion, and addressing societal concerns related to opioid misuse.

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References

1. Centers for Disease Control and Prevention (CDC). Opioid Overdose Data. 2022.
2. National Cancer Institute. Cancer Prevalence and Pain Management Data. 2023.
3. World Health Organization. Cancer Treatment Guidelines. 2022.
4. FDA Label for FENTORA. 2011.
5. Market research reports from IQVIA and EvaluatePharma. 2023.