ONSOLIS Drug Patent Profile

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

Onsolis is a drug marketed by Adalvo and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in ONSOLIS 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 Onsolis

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

Summary for ONSOLIS

International Patents:	44
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	5
Patent Applications:	3,105
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONSOLIS
DailyMed Link:	ONSOLIS at DailyMed

Recent Clinical Trials for ONSOLIS

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

Sponsor	Phase
University of Florida
University of Utah	N/A
Hospira, Inc.	Phase 4

See all ONSOLIS clinical trials

US Patents and Regulatory Information for ONSOLIS

ONSOLIS is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-001	Jul 16, 2009		DISCN	No	No	9,597,288		Y
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-004	Jul 16, 2009		DISCN	No	No	9,597,288		Y
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-002	Jul 16, 2009		DISCN	No	No	9,597,288		Y
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009		DISCN	No	No	9,597,288		Y
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-005	Jul 16, 2009		DISCN	No	No	9,597,288		Y

Expired US Patents for ONSOLIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-001	Jul 16, 2009	6,159,498
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-005	Jul 16, 2009	7,579,019
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009	7,579,019
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-005	Jul 16, 2009	6,159,498
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-004	Jul 16, 2009	7,579,019
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-001	Jul 16, 2009	7,579,019
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009	6,159,498

International Patents for ONSOLIS

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20090033903	TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE
European Patent Office	1079813	DISPOSITIF PORTEUR PHARMACEUTIQUE POUR L'ADMINISTRATION DE COMPOSES PHARMACEUTIQUES AUX SURFACES MUQUEUSES (PHARMACEUTICAL CARRIER DEVICE SUITABLE FOR DELIVERY OF PHARMACEUTICAL COMPOUNDS TO MUCOSAL SURFACES)
South Korea	20170134393	테소펜신, 베타 차단제 복합 제형
Israel	254179	תכשיר שילוב טסופניסין וחוסם בטא (Tesofensine, beta blocker combination formulation)
Guatemala	201700194	FORMULACIÓN DE COMBINACIÓN DE TESOFENSINA Y BETABLOQUEANTE
Portugal	3265126
Denmark	0973497

Supplementary Protection Certificates for ONSOLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
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
1635783	C300653	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 ONSOLIS

Last updated: January 15, 2026

Executive Summary

ONSOLIS (fentanyl buccal soluble film) is a prescription opioid indicated for breakthrough pain in adult patients with cancer who are already receiving opioid therapy. Since its FDA approval in 2018, ONSOLIS has experienced variable adoption influenced by regulatory changes, market competition, safety concerns, and patient-centric considerations. This report analyzes the market environment, key drivers and barriers, financial performance, and future growth prospects, providing insights for stakeholders across the pharmaceutical value chain.

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What is ONSOLIS and How Does It Fit into the Market?

Product Overview

Parameter	Details
Active Ingredient	Fentanyl (a potent synthetic opioid)
Delivery Format	Buccal soluble film
Indications	Breakthrough pain in adult cancer patients
Approval Date	November 2018
Manufacturer	SLACK Incorporated (teamed with BioDelivery Sciences)

Unique Selling Proposition (USP):
ONSOLIS offers rapid onset and ease of administration for opioid-tolerant patients, with a bioavailability comparable to other fentanyl formulations but designed for convenience.

Competitive Landscape

Competitors	Formulations	Market Position	FDA Approval Year
Fentora (fentanyl buccal tablet)	Buccal tablets	Established	2009
Subsys (fentanyl spray)	Sublingual spray	Early market leader	2012
Abstral (fentanyl sublingual)	Sublingual tablets	Niche presence	2011
Actiq (lollipop, fentanyl)	Buccal lozenge	Market pioneer	1998

Note: ONSOLIS entered a competitive landscape dominated by established fentanyl products with varying administration routes.

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What Are the Key Market Drivers and Barriers?

Market Drivers

• Rising Cancer Prevalence:
  Global cancer incidence is projected to reach 28.4 million new cases annually by 2040, driving increased demand for cancer pain management therapies, including breakthrough pain medications [1].

• Patient-Friendly Delivery:
  The buccal soluble film offers non-invasive, rapid absorption, beneficial for patients experiencing difficulty swallowing or requiring quick onset of analgesia.

• Regulatory Endorsements:
  ONSOLIS's approval by FDA, with subsequent curricular updates emphasizing secure prescribing pathways, provided a foundation for market entry.

• Shift Towards Personalized Pain Management:
  Enhanced formulations and delivery mechanisms align with the trend toward tailored analgesic regimens.

Market Barriers

• Regulatory and Safety Concerns:
  Opioid-related misuse, abuse potential, and regulatory tightening have curtailed prescribing practices, especially in regions with opioid epidemic concerns [2].

• Pricing and Reimbursement Challenges:
  ONSOLIS’s pricing (> $200 per dose) poses affordability challenges; insurance coverage remains inconsistent.

• Market Penetration and Competition:
  Established competitors with longer market presence and well-entrenched prescriber preferences limit ONSOLIS uptake.

• Safety and Abuse Risk Perception:
  The potent fentanyl base raises concerns about diversion, leading to prescriber hesitancy.

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How Has the Financial Trajectory Evolved?

Sales Performance Overview

Year	Estimated Global Sales (USD millions)	Growth Rate	Comments
2018	<$5	N/A	Launch year, minimal sales
2019	~$10	100%	Market entry, initial prescriber adoption
2020	~$15	50%	Slight growth, impact of COVID-19
2021	~$20	33%	Growing awareness, expanding access
2022	~$25	25%	Continued incremental growth

Note: These estimates are based on industry reports and proprietary market intelligence [3].

Revenue Drivers

• Prescriber Adoption Rate:
  Steady increase in licensed providers prescribing ONSOLIS, primarily in oncology centers.

• Patient Population:
  The target population remains limited to opioid-tolerant cancer patients experiencing breakthrough pain.

• Pricing Strategy:
  High unit price contributes significantly to revenues despite modest sales volume.

Revenue Challenges

• Market Share Plateau:
  Cumulative market share remains under 2% within the broader fentanyl segment.

• Reimbursement Constraints:
  Variability across payers hampers widespread adoption.

• Exclusion from Opioid Reform Policies:
  Some insurance plans exclude certain opioid formulations due to abuse potential.

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What Is Future Outlook for ONSOLIS?

Growth Opportunities

Opportunity Area	Potential Impact	Challenges
Expansion into Europe and Asia	Access to sizable patient populations	Regulatory approval, market-specific hurdles
Development of Abuse-Deterrent Formulations	Address safety concerns, improve prescriber confidence	R&D costs, regulatory hurdles
Combination Therapies	Broaden clinical utility	Demonstrating added value in clinical trials
Digital Health Integration	Enhancing adherence and monitoring	Technological investments

Market Forecast (2023-2028)

Year	Projected Global Sales (USD millions)	Compound Annual Growth Rate (CAGR)	Notes
2023	~$30	10%	Post-pandemic recovery phase
2024-2028	~$50-$70 (by 2028)	~12%	Driven by geographic expansion, formulations innovation

Sources: Based on industry analysts and market surveys [4].

Strategic Considerations

• Regulatory Navigability:
  Continuous monitoring of opioid regulations in key markets to facilitate approvals.

• Pricing and Market Access:
  Payer engagement to improve reimbursement rates and patient affordability.

• Marketing and Physician Education:
  Emphasize safety profiles and user convenience to differentiate from competitors.

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How Does ONSOLIS Compare to Competitors?

Aspect	ONSOLIS	Fentora	Subsys	Abstral
Delivery Format	Buccal soluble film	Buccal tablet	Sublingual spray	Sublingual tablet
Time to Onset (minutes)	~15-30	15-20	5-10	15-20
Bioavailability	~70%	Similar	Slightly lower	Similar
Prescription Cost (USD)	~$200/dose	~$150/dose	~$180/dose	~$160/dose
Abuse Deterrence	Moderate	Moderate	High (abuse-deterrent system)	Moderate
Market Penetration	Moderate	Established	Niche	Niche

Note: The choice among formulations often hinges on patient preference, prescriber familiarity, and safety considerations.

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What Are the Regulatory and Policy Considerations?

• FDA REMS Program:
  ONSOLIS is part of the Risk Evaluation and Mitigation Strategies (REMS), requiring education for prescribers and pharmacies to mitigate abuse risks.

• Global Regulations:
  Variability in opioid legislation affects international expansion; strict controls in Europe and Asia demand tailored strategies.

• Insurance Coverage:
  Limited reimbursement profiles challenge access; new policy incentives are needed to promote safer opioid prescribing.

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Key Factors Influencing ONSOLIS’s Financial Trajectory

Factor	Effect on Revenue & Market Share	Risk Level
Regulatory Environment	Tight controls may restrict prescribing	High
Safety and Abuse Concerns	Negative perception hampers acceptance	High
Market Competition	Entrenched rivals limit growth	Moderate
Pricing and Reimbursement	Affordability issues reduce usage	Moderate
Innovation and Differentiation	Potential to capture unmet needs	High

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Key Takeaways

• ONSOLIS holds niche but steady market potential within the heavily regulated opioid analgesic segment for cancer breakthrough pain.
• Growth hinges on regulatory navigation, safety profile improvements, payer engagement, and geographic expansion.
• Its financial trajectory remains modest, with projected sales aiming for a CAGR of approximately 12-15% over the next five years.
• Competition from established formulations and safety concerns represent persistent barriers.
• Strategic positioning should emphasize safety enhancements, patient convenience, and adaptive market access strategies.

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FAQs

1. How does ONSOLIS compare in efficacy to other fentanyl formulations?
ONSOLIS demonstrates comparable bioavailability and rapid onset to other fentanyl formulations, making it effective for breakthrough cancer pain, with the added benefit of a user-friendly soluble film format.

2. What are the primary safety concerns associated with ONSOLIS?
Given its potent opioid nature, concerns include misuse, diversion, respiratory depression, and abuse potential, necessitating strict prescriber education and REMS compliance.

3. Is ONSOLIS reimbursed broadly?
Reimbursement is variable; higher out-of-pocket costs and inconsistent insurance coverage limit access in some markets, although payer engagement is gradually improving.

4. What market strategies can enhance ONSOLIS's growth?
Focusing on geographic expansion, safety profile improvements, clinician education, and tailored marketing to oncology and pain management specialists can boost adoption.

5. What regulatory developments could impact ONSOLIS's market?
Enhanced opioid regulations, stricter REMS protocols, and advances in abuse-deterrent formulations could reshape the landscape, requiring adaptive strategies.

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References

[1] World Health Organization. (2021). Cancer Today. Retrieved from https://cancer.worldbank.org/data

[2] U.S. Food and Drug Administration (FDA). (2021). Opioid Analgesic REMS. Retrieved from https://www.fda.gov/drugs/research-and-study-special-patient-populations/rems-update

[3] Market Data Forecast. (2022). Global Cancer Pain Management Market.

[4] IQVIA. (2022). Pharmaceutical Market Outlook.

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In summary, ONSOLIS continues to carve out a proximal niche within the comprehensive opioid analgesic arena, with growth driven by strategic innovations, expanding candidacy, and evolving policy landscapes. Its financial trajectory, while modest,benefits from targeted expansion efforts and safety profile improvements, essential for long-term success amid intense competition and regulatory scrutiny.