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
M.D. Anderson Cancer Center	Phase 3
National Cancer Institute (NCI)	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	7,862,833		Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		DISCN	Yes	No	7,862,833		Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	Yes	No	7,862,833		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	021947-002	Sep 25, 2006	8,765,100
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006	8,728,441
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006	8,765,100

International Patents for FENTORA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1082106
Taiwan	200611697	Generally linear effervescent oral fentanyl dosage form and methods of administering
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)

Supplementary Protection Certificates for FENTORA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
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

Market Dynamics and Financial Trajectory for FENTORA

Last updated: July 28, 2025

Introduction

FENTORA, a sublingual form of fentanyl, is a potent opioid analgesic indicated primarily for breakthrough cancer pain management in opioid-tolerant patients. Since its approval by the U.S. Food and Drug Administration (FDA) in 2012, FENTORA has positioned itself within the complex landscape of opioid analgesics amidst evolving regulatory standards, market competition, and rising global cancer incidences. Understanding the drug’s market dynamics and financial trajectory is vital for stakeholders evaluating investment, development, or market entry strategies in the niche of strong opioid therapeutics.

Market Overview and Demand Drivers

The global opioid analgesics market is driven by the rising prevalence of chronic pain conditions, especially cancer-related pain. According to the World Health Organization (WHO), approximately 10 million people worldwide develop cancer annually, with a significant subset experiencing breakthrough pain requiring potent opioids like FENTORA.[1] The increasing adoption of novel formulations that improve bioavailability and patient compliance further fuels demand.

Cancer Incidence and Pain Management Needs

Cancer prevalence is a primary driver. Countries with aging populations, such as the U.S., Japan, and European nations, witness higher cancer and associated pain management needs. The U.S., for example, reports over 1.9 million new cancer diagnoses annually, with pain control a critical component of palliative care.[2] As treatment paradigms emphasize quality of life, the utilization of fast-acting opioids like FENTORA is ascending.

Opioid Prescription Trends

The heightened focus on pain management—including advances in outpatient and home-based care—propels demand for user-friendly, rapid-onset opioids. FENTORA’s sublingual route provides quick absorption, appealing to clinicians managing breakthrough pain episodes. However, prescription patterns are tightly intertwined with regulatory policies and clinician prescribing behaviors, influencing market dynamics.

Regulatory and Legal Landscape

FENTORA's trajectory is significantly influenced by the regulatory environment. Strict opioid regulations, particularly in the U.S., where the CDC issued guidelines to curb misuse, have tempered growth prospects temporarily.[3] Nevertheless, ongoing refinements in prescribing practices and abuse-deterrent formulations aim to balance effective pain control with abuse prevention.

Furthermore, international regulatory variations influence market access. While North America and Europe remain primary markets, emerging economies are gradually adopting opioid-based pain therapies, subject to policy reforms and healthcare infrastructure development.

Competitive Landscape

FENTORA faces competition from multiple opioid formulations, including transmucosal, transdermal, injectable, and oral products. Key competitors include:

• DURAGESIC (fentanyl transdermal patch): Offers long-acting pain relief, though less suitable for breakthrough pain.
• Abstral (fentanyl sublingual tablets): Provides rapid relief but in a different formulation.
• Actiq (fentanyl lozenges): Offers similar rapid absorption with different administration modalities.

Innovations such as abuse-deterrent formulations and novel delivery systems threaten to reshape market positioning. Additionally, the rising use of non-opioid analgesics for certain pain indications could impact future demand.

Financial Trajectory and Revenue Trends

Since its inception, FENTORA’s revenue performance has fluctuated, marked by initial growth and subsequent stabilization:

• Initial Launch Phase (2012-2015): The drug captured significant market share driven by unmet needs in breakthrough pain. Peak sales occurred in this period, supported by clinical adoption and payer reimbursement.

• Market Saturation & Regulatory Impact (2016-2018): Growth plateaued amid intensified scrutiny on opioid prescribing and the advent of alternative therapies. Revenue declines or stagnation ensued in several mature markets like the U.S. and Europe.

• Recent Trends (2019-2023): The adoption of digital health tools, targeted marketing, and expansion into emerging regions contributed to modest revenue upticks. However, legal challenges and increased oversight threaten sustained growth.

Regional Revenue Insights

• United States: Dominates revenue streams due to high cancer prevalence and established prescribing protocols. However, growth is constrained by regulatory hurdles and reimbursement policies.

• Europe: Shows moderate growth with varied regulatory acceptance across member states.

• Emerging Markets: Presents organic growth potential, albeit limited by healthcare infrastructure and regulatory barriers.

Future Outlook

The near-term financial trajectory for FENTORA remains cautiously optimistic. Market analysts project a compounded annual growth rate (CAGR) of approximately 3-5% over the next five years, reflective of incremental regional expansions and ongoing prescription of breakthrough pain medications.[4]

However, the potential for market contraction exists due to:

• Intensified regulation aimed at curtailing opioid misuse.
• The emergence of abuse-deterrent formulations.
• Shifts toward non-opioid pain management strategies.

Strategic Considerations for Stakeholders

• Regulatory Engagement: Proactive adherence and advocacy to ensure equitable access amidst tightening regulations.
• Diversification: Development of alternative formulations or combination therapies that address abuse potential.
• Market Penetration: Focused efforts in underserved regions with rising cancer burdens.
• Patient-Centric Approaches: Leveraging technology for improved administration, adherence, and monitoring.

Key Takeaways

• Growing Need: The increasing global cancer burden sustains demand for rapid-onset opioids like FENTORA, especially in developed nations with established palliative care protocols.
• Regulatory Challenges: Strict opioid policies pose hurdles, necessitating adaptive strategies to maintain market share.
• Competitive Dynamics: FENTORA operates within a competitive landscape of similar formulations, with innovation and abuse-deterrent features becoming essential differentiators.
• Financial Trajectory: Revenue growth is moderate, influenced by regional variances and external policy forces; proactive market engagement is critical.
• Future Outlook: While incremental growth is anticipated, the long-term financial trajectory depends on regulatory evolution, alternative therapy developments, and expansion into emerging markets.

Conclusion

FENTORA’s market and financial trajectory exemplify the intricate balance between unmet clinical needs and regulatory complexities. Stakeholders must navigate this landscape with strategic agility, emphasizing innovation, compliance, and regional expansion to sustain growth in this volatile yet essential segment of opioid analgesics.

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FAQs

1. How does FENTORA compare to other fentanyl formulations in efficacy?
FENTORA provides rapid sublingual absorption, making it effective for breakthrough pain. Its onset is quicker than transdermal patches like DURAGESIC, making it preferable for episodic pain. However, the choice depends on patient-specific factors and clinician judgment.

2. What are the main regulatory concerns surrounding FENTORA?
Regulatory agencies focus on risks of misuse, abuse, and accidental exposure. The formulation's potent nature mandates stringent prescribing protocols, and abuse-deterrent features are increasingly emphasized.

3. Can FENTORA see increased adoption in emerging markets?
Yes, as healthcare infrastructure improves and cancer prevalence rises, markets such as Asia and South America present growth opportunities. However, regulatory acceptance and healthcare system adaptations are prerequisites.

4. What role does innovation play in FENTORA’s future success?
Developing abuse-deterrent formulations and alternative delivery systems will be key to maintaining competitiveness, especially amid heightened scrutiny of opioids.

5. How do changes in cancer treatment influence FENTORA’s market?
Advancements leading to improved pain management or alternative therapies could reduce dependence on opioids like FENTORA for breakthrough pain, impacting long-term demand.

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References
[1] WHO. Cancer Key Facts. 2022.
[2] American Cancer Society. Cancer Facts & Figures. 2023.
[3] CDC. Opioid Prescribing Guidelines. 2016.
[4] MarketResearch.com. Global Pain Management Market Forecast. 2022.