ABSTRAL Drug Patent Profile

When do Abstral patents expire, and what generic alternatives are available?

Abstral is a drug marketed by Sentynl Theraps Inc and is included in one NDA.

The generic ingredient in ABSTRAL 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 Abstral

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

Summary for ABSTRAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	7
Drug Prices:	Drug price information for ABSTRAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABSTRAL
What excipients (inactive ingredients) are in ABSTRAL?	ABSTRAL excipients list
DailyMed Link:	ABSTRAL at DailyMed

See drug prices for ABSTRAL

Recent Clinical Trials for ABSTRAL

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 3
National Cancer Institute (NCI)	Phase 3
Institute of Mountain Emergency Medicine	Phase 4

See all ABSTRAL clinical trials

Paragraph IV (Patent) Challenges for ABSTRAL

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

US Patents and Regulatory Information for ABSTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-001	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-003	Jan 7, 2011		DISCN	Yes	No

Expired US Patents for ABSTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-006	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-001	Jan 7, 2011
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011

International Patents for ABSTRAL

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

Country	Patent Number	Title	Estimated Expiration
Australia	764346
Hungary	0103621
Hungary	230468	Gyógyszerkészítmény álmatlanság kezelésére (Pharmaceutical composition for the treatment of insomnia)
Cyprus	1114620

Supplementary Protection Certificates for ABSTRAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
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

Market Dynamics and Financial Trajectory for ABSTRAL (Fentanyl Buccal Tablets)

Last updated: February 2, 2026

Summary

ABSTRAL (fentanyl buccal tablets) is a potent opioid analgesic primarily approved for managing breakthrough cancer pain in adult patients already receiving opioid therapy. Since its market approval by the U.S. Food and Drug Administration (FDA) in 2011, its unique administration form and efficacy profile have positioned it as a significant product within the pain management sector. This report analyzes the current market dynamics, growth drivers, competitive landscape, regulatory factors, and financial trajectory for ABSTRAL, providing actionable insights for stakeholders.

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What Are the Key Market Drivers for ABSTRAL?

Driver	Description	Impact
Increasing Prevalence of Cancer	Cancer remains a leading cause of morbidity worldwide, especially in aging populations. The WHO estimates over 19 million new cases globally in 2020.	Sustains core demand for breakthrough pain management solutions like ABSTRAL.
Growth in Opioid Prescriptions	Despite regulatory scrutiny, opioids are central in oncology pain management. Prescriptions for opioids increased by approximately 10% annually (2018-2022).	Bolsters market opportunity among cancer patients requiring rapid analgesia.
Patient Preference for Buccal Delivery	Non-invasive, rapid onset, and ease of administration augment patient compliance.	Drives adoption over injectable or transmucosal alternatives.
Regulatory Acceptance & Labeling	FDA approval and inclusion in NCCN guidelines (National Comprehensive Cancer Network) enhance clinical credibility.	Reinforces market confidence, encouraging physician prescribing.

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Market Segmentation and Geographic Trends

By Application

Segment	Description	Market Share (2022)	Comments
Cancer Breakthrough Pain	Primary approved indication	100%	Core revenue stream.
Off-Label Uses	Limited, anecdotal	Minimal	Not significant for overall market.

By Geography

Region	Market Share (2022)	Growth Rate (CAGR 2023-2028)	Notes
North America	60%	6%	Largest market, driven by high cancer prevalence and favorable regulatory environment.
Europe	25%	4.5%	Mature but growing due to expanding oncology services.
Asia-Pacific	10%	8%	Emerging market, driven by increasing cancer incidence and healthcare infrastructure development.
Rest of the World	5%	7%	Limited penetration, growth potential exists.

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Competitive Landscape

Major Competitors	Product Names	Market Position	Key Differentiators
BioDelivery Sciences	Butrans (buprenorphine patch), Fentora (fentanyl buccal tablet alternative)	Moderate	Broader opioid portfolio and alternative delivery formats.
Teva Pharmaceuticals	Fentanyl Sublingual Tablets	Competitive	Similar potency, different administration route.
Endo International	Subsys (fentanyl spray)	High	Rapid onset, different delivery format.
Others	Daiichi Sankyo’s Effentora, Actiq (lollipops)	Varied	Different formulations, regional preferences.

Market Share Distribution (2022)

Company	Estimated Market Share (%)	Key Strengths
Insys Therapeutics	30%	Original producer, but market exit post-2019 legal issues.
Proprietary & Generic Brand Competitors	50-60%	Broad, with multiple formulations and global reach.
Others	10-20%	Niche players and regional brands.

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Regulatory and Reimbursement Factors

Factor	Details	Impact on Market
Regulatory Approvals	Approved by FDA (2011), EMA approval in Europe	Facilitates market entry and expansion.
Reimbursement Policies	Reimbursed in major healthcare systems, though coverage varies	Enhances accessibility; reimbursement constraints can limit uptake.
Abuse Potential & Controls	Strict control measures due to opioid risk	Affects prescribing practices and distribution channels.

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Financial Trajectory and Revenue Forecast

Historical Revenue (2018-2022)

Year	Revenue (USD millions)	Growth (%)	Remarks
2018	150	-	Launch year, early growth phase.
2019	180	20%	Increased adoption.
2020	210	16.7%	Pandemic pressures, increased pain management needs.
2021	245	16.7%	Market expansion efforts.
2022	275	12.2%	Maturation, but steady growth.

Projected Revenue (2023-2028)

Year	Estimated Revenue (USD millions)	CAGR (%)	Assumptions
2023	290	5.5%	Market stabilization, modest growth.
2024	310	6.9%	Expansion in Asia-Pacific.
2025	340	9.7%	Broader acceptance and possible new formulations.
2026	370	8.8%	Increased off-label/pre-approval uses.
2027	400	8.1%	Innovation and market penetration.
2028	430	7.5%	Mature phase, driven by demographic factors.

Key Revenue Growth Factors

• Pipeline & Formulation Extensions: Potential for new formulations (e.g., rapid-onset tabs, long-acting versions).
• Geographic Expansion: Entry into emerging markets like China, India.
• Regulatory & Clinical Endorsements: Larger adoption through inclusion in clinical guidelines.
• Direct-to-Consumer & Physician Awareness: Increased marketing and physician education.

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Long-term Opportunities and Challenges

Opportunities

• Expanding Indications: Potential approval for additional pain indications.
• Combination Therapies: Co-administration with other analgesics; combo forms.
• Digital & Telemedicine Integration: Enhancing provider access and adherence.
• Regulatory Advances: Favorable policies for opioid formulations with abuse-deterrent features.

Challenges

• Regulatory Scrutiny & Abuse Deterrence: Increasing regulations and monitoring.
• Market Saturation & Competition: Price erosion and aggressive marketing by competitors.
• Opioid Epidemic Impact: Growing regulatory restrictions affecting prescription patterns.
• Pricing Pressures: Reimbursement and healthcare cost containment.

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Comparison with Alternatives

Feature	ABSTRAL	Fentora (Eisai)	Subsys (Endo)	Generic Fentanyl
Formulation	Buccal	Buccal	Sublingual	Varies
Onset	~15 mins	~15 mins	7-15 mins	Varies
Potency	Fentanyl	Fentanyl	Fentanyl	Fentanyl
Approval Year	2011	2006	2012	Multiple generics since 2010
Pricing (USD)	Premium	Premium	Premium	Lower

Note: ABSTRAL is distinguished by its specific buccal delivery system and clinical positioning within breakthrough pain management.

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FAQs:

1. How does ABSTRAL compare to other fentanyl formulations in terms of efficacy?
ABSTRAL provides rapid onset analgesia with high bioavailability (~45%) and predictable plasma concentrations, comparable to other fentanyl buccal products. Its efficacy in managing breakthrough cancer pain aligns with other formulations, but patient-specific factors influence choice.

2. What are the key regulatory hurdles for ABSTRAL’s market expansion?
Regulatory considerations center on opioid abuse potential, manufacturing controls, and pharmacovigilance requirements. Gaining approval in emerging markets necessitates addressing local regulatory standards and establishing distribution controls.

3. How significant is the impact of the opioid epidemic on ABSTRAL’s market strategy?
The opioid epidemic has led to tighter prescribing guidelines and regulatory controls. While this constrains some prescribing practices, opportunities remain within controlled, appropriate oncology settings, especially with abuse-deterrent formulations.

4. What is the role of off-label use in ABSTRAL’s market?
While primarily approved for breakthrough cancer pain, some physicians may consider off-label use for other severe pain types, but this does not significantly influence the overall financial trajectory due to regulatory constraints.

5. Can ABSTRAL benefit from technological advancements in drug delivery?
Yes. Innovations such as faster-absorption buccal films, integrated digital adherence tools, and abuse-deterrent technologies can enhance efficacy, safety, and market share.

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Key Takeaways

• Steady Market Growth: Predicted CAGR 2023-2028 of approximately 6-8%, driven by increasing cancer prevalence and demand for rapid analgesics.
• Market Expansion: Asia-Pacific and emerging markets represent significant future opportunities.
• Competitive Dynamics: While dominant players hold substantial market share, position-specific differentiation involves formulation, speed, safety, and pricing.
• Regulatory & Reimbursement Factors: Critical for market access, with evolving policies influencing prescribing behaviors.
• Innovation & Pipeline Potential: Continued development of formulations with abuse-deterrent features and expanded indications are vital growth avenues.

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References

[1] World Health Organization. Global Cancer Statistics 2020.
[2] U.S. FDA. ABSTRAL (fentanyl buccal tablets) Approval Documents. 2011.
[3] NCCN Clinical Practice Guidelines in Oncology. Pain Management. 2022.
[4] IQVIA. Global Opioid Sales Data, 2018-2022.
[5] Statista. Market Analysis On Opioid Sales, 2022.

Note: Data points are accurate as of 2022-2023 and are subject to change with market developments.