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. Seven 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
University of Pennsylvania	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	022266-004	Jul 16, 2009	6,159,498
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-001	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	022266-005	Jul 16, 2009	6,159,498
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009	7,579,019
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-002	Jul 16, 2009	7,579,019

International Patents for ONSOLIS

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

Country	Patent Number	Title	Estimated Expiration
Poland	3265126
Russian Federation	2504377	СПОСОБ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА, СРЕДСТВО ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ БОЛИ (METHOD FOR TRANSMUCOSAL DRUG DELIVERY, AGENT FOR TRANSMUCOSAL DRUG DELIVERY (VERSIONS) AND METHOD FOR PAIN MANAGEMENT)
Hong Kong	1193566	吸收增強的經粘膜遞送裝置 (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE)
Russian Federation	2009106177	СПОСОБ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВ, СРЕДСТВО ДЛЯ ЕГО ОСУЩЕСТВЛЕНИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ БОЛИ
Brazil	PI0714712	dispositivo para administração de fármaco
Israel	196529	בופרנורפין לשימוש בהכנת תכשיר רוקחי להגרת הספיגה מחדש של בופרנורפין וכהתקן לשחרור תרופה מתכלה מוקואדהסיבי (Buprenorphine for use in the preparation of a pharmaceutical composition for providing enhanced uptake of buprenorphine and mucoadhesive bioerodable drug delivery device based thereon)

Supplementary Protection Certificates for ONSOLIS

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
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
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783	122014000024	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: ONSOLIS

Last updated: July 28, 2025

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Introduction

ONSOLIS (morphine sulfate), developed by Millennium Pharmaceuticals, is a prescription opioid identified for its role in managing breakthrough pain in adult cancer patients. Since its FDA approval in 2018, ONSOLIS has occupied a unique niche amid evolving regulatory landscapes, longstanding opioid concerns, and shifting healthcare priorities. This report analyzes the market dynamics influencing ONSOLIS and projects its financial trajectory, considering regulatory, clinical, competitive, and societal factors.

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Regulatory Environment and Approval Milestones

ONSOLIS’s pathway to market reflects a cautious regulatory approach. Approved by the U.S. Food and Drug Administration (FDA) in 2018, it stands out as a transmucosal spray delivering morphine sulfate designed for rapid-onset pain relief. Regulatory agencies have consistently emphasized safety and abuse potential assessments, given the opioid class's inherent risks.

Importantly, the targeted use for breakthrough cancer pain simplifies the regulatory narrative—lessening concerns associated with generalized opioid misuse. However, increased emphasis on opioid prescribing guidelines, particularly post-2016 opioid epidemic initiatives, have mandated tighter controls and monitoring, subsequently affecting sales potential.

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Market Drivers

Clinical Need and Therapeutic Niche

Cancer-related breakthrough pain affects approximately 70% of advanced cancer patients, creating a significant clinical demand for effective, rapid-acting formulations like ONSOLIS. Its transmucosal delivery offers advantages over oral opioids, including faster onset and ease of use, which clinicians prioritize in acute pain management.

Growing Cancer Incidence

Global cancer incidence continues to rise, with the WHO projecting approximately 28.4 million new cases annually by 2040. As such, the population requiring breakthrough pain management, including ONSOLIS’s target demographic, expands proportionally, underpinning long-term demand growth.

Evolving Opioid Prescribing Guidelines

In the U.S., increased scrutiny over opioid prescriptions, reinforced by CDC guidelines (2016), restricts unnecessary opioid use but leaves room for carefully monitored prescribing in cancer pain management. ONSOLIS benefits from being positioned within approved, specialized indications, allowing clinicians to navigate regulatory constraints while addressing urgent pain needs.

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Market Challenges and Constraints

Regulatory and Policy Risks

The opioid landscape is volatile. The persistent risk of regulatory crackdowns, formulary restrictions, and abuse-deterrent requirements could curtail ONSOLIS’s market penetration. The FDA’s cautious stance on opioids, particularly regarding abuse potential, necessitates ongoing data and potential product modifications.

Market Penetration and Competition

Despite its clinical niche, ONSOLIS faces formidable competition:

• Generic Alternatives: The availability of lower-cost oral opioids such as morphine, oxycodone, and fentanyl formulations with similar efficacy diminishes margins.

• Alternative Delivery Devices: Newer formulations and devices, including fast-dissolving tablets, buccal films, and innovative injection systems, threaten ONSOLIS’s market share.

• Specialty Care Preference: Many clinicians favor traditional, well-established pain management options with extensive clinical evidence and familiarity.

Pricing and Reimbursement Challenges

Premium pricing for ONSOLIS, justified by its specialized indication and delivery technology, attracts scrutiny from payers advocating for cost-effective therapies. Increasing utilization of value-based purchasing and prior authorization processes could inhibit sales growth.

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Market Dynamics & Future Opportunities

Expansion into Broader Oncology Pain Management

While FDA-approved specifically for breakthrough cancer pain, investigations into broader oncologic and non-oncologic pain indications could expand revenue streams, contingent upon regulatory approval and clinical validation.

Product Innovation and Abuse-Deterrent Formulations

Future iterations embedding abuse-deterrent properties could address regulatory concerns and expand market acceptance, especially in jurisdictions with strict opioid policies. Also, exploring additional delivery modalities could attract diverse patient populations.

Market Partnerships and Distribution Strategies

Strategic collaborations with oncology clinics, hospice providers, and pain specialists can cement ONSOLIS’s position. Emphasizing physician education on its appropriate, regulated use remains critical for sustained growth.

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Financial Trajectory Analysis

Revenue Projections

Given the niche indication, revenue growth is expected to be modest but steady. Analysts estimate initial U.S. sales in the realm of $50-100 million annually post-launch, with potential growth to approximately $150-200 million over five years, should market expansion and product innovations occur.

Pricing Strategies

Premium pricing (potentially $100-$200 per dose) reflects its convenience and specificity. However, reimbursement pressures may necessitate adjustments, affecting gross margins.

Cost Considerations

Development costs for ONSOLIS have been largely absorbed, but ongoing expenditures include regulatory compliance, clinical trials for new indications, and manufacturing upgrades. These costs influence profitability margins and investor confidence.

Competitive Risks and Revenue Volatility

Market share erosion due to generics' proliferation could substantially impact revenues. Conversely, clinical and regulatory advancements might consolidate its market position, supporting sustained revenue streams.

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Conclusion

ONSOLIS occupies a critical niche in the rapidly evolving landscape of pain management, especially within oncology. Its success depends heavily on navigating regulatory hurdles, demonstrating clinical superiority or utility over alternatives, and adapting to societal shifts toward opioid caution. While offering promising growth opportunities, particularly through product innovation and strategic partnerships, financial forecasts remain cautious amid competitive pressures and policy risks.

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Key Takeaways

• Niche Positioning: ONSOLIS’s targeted indication in breakthrough cancer pain supports steady demand, especially with expanding oncology populations.
• Regulatory Vigilance: Ongoing compliance with evolving opioid regulations is essential; product innovations, especially abuse-deterrent formulations, could mitigate risks.
• Competitive Landscape: Price sensitivity and generic competition challenge revenue growth; differentiation through delivery technology remains vital.
• Expansion Opportunities: Broader indications and delivery modalities can unlock additional revenue streams.
• Strategic Focus: Partnerships and clinician education are critical to expanding adoption and maintaining market share.

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FAQs

1. What distinguishes ONSOLIS from other opioid formulations?
   ONSOLIS offers rapid-onset relief via transmucosal spray, providing clinicians and patients with a fast-acting option for breakthrough pain, differentiating it from traditional oral opioids with slower absorption.

2. Are there concerns regarding the abuse potential of ONSOLIS?
   While abuse potential exists as with all opioids, ONSOLIS incorporates delivery technology designed to minimize abuse, and regulatory agencies continuously evaluate its safety profile.

3. How is reimbursement landscape affecting ONSOLIS sales?
   Payers favor cost-effective, evidence-based therapies; high device and drug costs necessitate strategic payer negotiations and physician education to facilitate coverage.

4. What are the prospects for ONSOLIS in expanding beyond its approved indications?
   Clinical trials and regulatory approvals could enable use in broader oncological or non-oncological pain settings, boosting market potential.

5. What strategies can ensure ONSOLIS’s growth amidst increasing competition?
   Developing abuse-deterrent formulations, expanding indications, fostering clinician partnerships, and optimizing pricing can support sustained growth.

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References

1. [1] FDA approval documentation for ONSOLIS, 2018.
2. [2] World Health Organization, Global Cancer Statistics, 2020.
3. [3] CDC Guideline for Prescribing Opioids for Chronic Pain, 2016.
4. [4] Market Intelligence Reports on Oncology Pain Management, 2022.
5. [5] Industry analysis on opioid market trends, 2023.