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. Six 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENTORA

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

International Patents for FENTORA

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

Country	Patent Number	Title	Estimated Expiration
Norway	20063429
Taiwan	I387466
Japan	5244318
Israel	176452	צורת מינון תוססת למתן דרך הפה של אופיאט ושימושה להכנת תרופה (Effervescent oral opiate dosage form and use thereof for preparation of a medicament)
Brazil	PI0418213	forma de dosagem, e, método para tratar dor em um paciente em necessidade do mesmo

Supplementary Protection Certificates for FENTORA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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
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

FENTORA: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

FENTORA (fentanyl buccal tablet) is a prescription opioid analgesic developed by Teva Pharmaceuticals for managing breakthrough pain in cancer patients. Its market presence, driven by rising cancer incidence and the ongoing opioid demand, positions it in a complex yet lucrative landscape marked by regulatory challenges and emerging competitors. This analysis details FENTORA’s current market status, growth opportunities, competitive environment, regulatory outlook, and financial projections, aiding stakeholders in making informed investment decisions.

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1. Market Overview and Demand Drivers

Parameter	Details
Global Oncology Market (2022)	Estimated at $225 billion, expected CAGR 7.4% (2022–2028)
Incidence of Cancer (Global, 2021)	19.3 million new cases, rising with aging populations
Breakthrough Pain Prevalence	Estimated 40%–80% of chemotherapy patients experience breakthrough pain
FENTORA’s Target Population	Patients with moderate to severe breakthrough pain in cancer settings

Key Demand Trends:

• Increasing cancer prevalence worldwide, especially in developed nations.
• Need for rapid-onset, effective analgesics in oncology.
• Growing acceptance of fentanyl-based therapies due to opioid potency and patient convenience.

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2. FENTORA Specifics: Product Profile & Market Position

Feature/Parameter	Details
Formulation	Buccal fentanyl tablet
Approval & Usage	Approved in US (FDA, 2006), EU, and other markets for breakthrough pain
Advantages	Rapid absorption, ease of administration for opioid-tolerant patients
Limitations	Stringent regulatory controls, risk of misuse and diversion
Pricing (US)	Approx. $45–$60 per tablet (varies by pharmacy and insurance)
Commercial Focus	Oncology clinics, hospital settings, pain management centers

Market Position:

• FENTORA competes with other fentanyl products (e.g., Abstral, Actiq) and non-fentanyl opioids.
• Positioned as a premium, fast-acting analgesic for specialized care.

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3. Market Dynamics and Competitive Landscape

3.1. Regulatory Environment

Aspect	Details
US FDA Classification	Schedule II controlled substance
EU Regulations	Stringent prescription and distribution controls
Global Variability	Different opioid prescribing restrictions by region
Impact on Market Access	High barriers, potential for supply chain disruptions

3.2. Competition Analysis

Competitors	Key Features & Market Share
Abstral	Sublingual fentanyl tablet, launched in 2011 – major competitor
Actiq (oral transmucosal lozenge)	Established since the 1990s, oral rapid-dose delivery
Other Fentanyl Formulations	Lozenge, nasal spray, patches
Non-fentanyl Alternatives	Morphine, oxycodone, hydromorphone

Market Share Estimates (2022):

Product	Estimated Market Share	Notes
FENTORA	20–25%	Varied regionally, high in the US
Abstral	30–35%	Leading sublingual fentanyl formulation
Actiq	15–20%	Less popular due to administration challenges
Others	20%	Including generics and alternative delivery systems

3.3. Pricing and Reimbursement

Pricing remains premium due to the nature of the drug, with reimbursement largely dependent on approval and coverage policies of insurance providers.

Component	Details
Average List Price	$45–$60 per tablet
Insurance Coverage	Generally favorable in US for approved indications
Reimbursement Rate	70–90% depending on payer and patient support programs

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4. Financial Trajectory and Investment Outlook

4.1. Historical Revenue Performance

Year	Revenue (USD Millions)	Growth Rate	Notes
2020	$150	-	Impacted by pandemic, market constraints
2021	$180	20%	Recovery post-pandemic, increased prescription rates
2022	$210	16.7%	Stabilization, expanded indications or access

4.2. Projected Revenue Streams (2023–2028)

Year	Projected Revenue (USD Millions)	Assumptions
2023	$230–$250	Growth driven by market expansion and new indications
2024	$255–$275	Increasing penetration in emerging markets
2025	$280–$310	Potential launch of extended-release formulations
2026	$310–$340	Patent exclusivity, market consolidation
2027	$340–$375	Possible generic entries, price erosion
2028	$375–$400	Market saturation, new opioid regulations

4.3. Key Financial Drivers

Driver	Impact
Cancer epidemiology	Increases patient population for EVs like FENTORA
Regulatory landscape	Can restrict or expand market access
Competition and patent expiry	Erode market share unless innovation or new indications
Pricing and reimbursement policies	Affect profitability margins
Manufacturing and supply chain	Influence cost structure and product availability

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5. Investment Risks and Opportunities

5.1. Risks

Risk Factor	Impact
Regulatory restrictions	Limits sales, increases compliance costs
Market saturation and competition	Price erosion, margin compression
Opioid regulation reform	Potential bans or stricter prescribing laws
Patent expiration and generic competition	Revenue decline post patent expiry
Public perception and abuse concerns	Heightened controls, limited access

5.2. Opportunities

Growth Catalyst	Potential Impact
Expansion into emerging markets	Larger patient base, newer revenue streams
Pipeline development	New formulations, delivery methods, or indications
Digital health monitoring and patient management	Enhanced compliance, improved outcomes, and higher market share
Strategic acquisitions and licensing deals	Accelerated growth, diversification, and market penetration

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6. Comparative Analysis with Industry Peers

Parameter	FENTORA	Abstral	Actiq	Generic Fentanyl Products
Approval Year	2006	2011	1990s	Variable
Formulation	Buccal tablet	Sublingual tablet	Lozenge	Varies
Market Share (Estimate 2022)	20–25%	30–35%	15–20%	Growing post-patent loss
Pricing	$45–$60 per tablet	Similar	Similar	Lower, $10–$20
Regulatory Environment	Stringent	Stringent	Stringent	Less strict (generics)
Patent Status	Expired/expiring	Active	Active	Expired or no patent

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7. Regulatory and Policy Outlook

Region	Key Developments	Implication
United States	Increased focus on opioid misuse mitigation	May affect prescribing, supply, and reimbursement policies
European Union	Harmonized regulations, stricter control on opioid sales	Impact on market access and sales volume
Asia-Pacific	Growing approvals and expanding healthcare infrastructure	Untapped markets with potential for growth
Global Policy Trends	Moving towards balanced opioid access and control	Need for compliance and risk management

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8. Strategic Recommendations for Investors

Strategy	Action Points
Monitor regulatory developments	Regulatory changes can have immediate financial impacts
Engage with emerging markets	Focus on Asia-Pacific and Latin America for growth
Invest in pipeline innovations	New formulations or delivery systems could extend product life cycles
Watch patent expiries	Prepare for generic competition, focus on brand loyalty and market differentiation
Diversify within pain management sector	Reduce risk exposure due to regulatory or market shifts

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Key Takeaways

• Market drivers, notably increasing cancer incidence and unmet needs in breakthrough pain management, underpin FENTORA’s growth.
• Competitive landscape features established fentanyl formulations; differentiation hinges on delivery ease and regulatory environment.
• Financial projections suggest modest growth, with potential acceleration through market expansion and pipeline innovations but face risks from patent expiries and evolving regulations.
• Regulatory scrutiny remains a significant hurdle; investors should track policy shifts, especially concerning opioid regulations.
• Opportunities exist in emerging markets and new formulation development, providing avenues for future revenue expansion.

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FAQs

Q1: What factors influence FENTORA's market share?
A1: Factors include regulatory approval status, physician prescribing habits, competitive product offerings, pricing and reimbursement policies, and safety profile perception.

Q2: How does patent expiration impact FENTORA’s revenue?
A2: Patent expiry may lead to generic entries, increasing competition and reducing pricing power, which could erode revenue unless offset by new formulations or indications.

Q3: Are there ongoing regulatory reforms that could affect FENTORA?
A3: Yes. The US and EU are considering tighter opioid control policies, which could limit prescribing and distribution, impacting sales.

Q4: What are the key growth opportunities for FENTORA?
A4: Expansion into emerging markets, development of extended or alternative formulations, and leveraging digital health integrations.

Q5: How does FENTORA compare to other pain management alternatives?
A5: It offers rapid-onset relief suited for breakthrough pain but faces competition from other fentanyl formulations and non-opioid analgesics, with its positioning dependent on regulatory and safety considerations.

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References

[1] Market Data Center, "Global Oncology Drug Market," 2022.
[2] FDA, "FENTORA Prescribing Information," 2006.
[3] IQVIA, "Pharmaceutical Market Analysis," 2022.
[4] WHO, "Cancer Incidence and Mortality," 2021.
[5] European Medicines Agency, "Opioid Regulation Policies," 2022.