ZUBSOLV Drug Patent Profile

When do Zubsolv patents expire, and when can generic versions of Zubsolv launch?

Zubsolv is a drug marketed by Orexo Us Inc and is included in one NDA. There are ten patents protecting this drug and four Paragraph IV challenges.

This drug has sixty-two patent family members in thirty-two countries.

The generic ingredient in ZUBSOLV is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zubsolv

A generic version of ZUBSOLV was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22^nd, 2013.

Summary for ZUBSOLV

International Patents:	62
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	8
Patent Applications:	298
Drug Prices:	Drug price information for ZUBSOLV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZUBSOLV
What excipients (inactive ingredients) are in ZUBSOLV?	ZUBSOLV excipients list
DailyMed Link:	ZUBSOLV at DailyMed

See drug prices for ZUBSOLV

Recent Clinical Trials for ZUBSOLV

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

Sponsor	Phase
Yale University	PHASE3
National Drug Abuse Treatment Clinical Trials Network	PHASE3
The Emmes Company, LLC	PHASE3

See all ZUBSOLV clinical trials

Pharmacology for ZUBSOLV

Drug Class	Opioid Antagonist Partial Opioid Agonist
Mechanism of Action	Opioid Antagonists Partial Opioid Agonists

Paragraph IV (Patent) Challenges for ZUBSOLV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	0.7 mg/0.18 mg	204242	1	2017-05-04
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	2.9 mg/7.1 mg	204242	1	2015-12-21
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	8.6 mg/2.1 mg and 11.4 mg/2.9 mg	204242	1	2015-07-24
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	1.4 mg/0.36 mg and 5.7 mg/1.4 mg	204242	1	2013-10-22

US Patents and Regulatory Information for ZUBSOLV

ZUBSOLV is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes			Y

Expired US Patents for ZUBSOLV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014

International Patents for ZUBSOLV

When does loss-of-exclusivity occur for ZUBSOLV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Denmark

European Patent Office

Japan

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZUBSOLV around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1652518
European Patent Office	2706986
Norway	332226
New Zealand	709502	New abuse-resistant pharmaceutical composition for the treatment of opioid dependence

Supplementary Protection Certificates for ZUBSOLV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	484	Finland
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

Market Dynamics and Financial Trajectory for ZUBSOLV: A Comprehensive Analysis

Last updated: December 31, 2025

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Executive Summary

ZUBSOLV (buprenorphine/naloxone) is a prescription medication approved by the FDA for opioid dependence treatment. Positioned as a sublingual film, ZUBSOLV targets a growing global opioid crisis and the expanding market for addiction therapy. This report synthesizes the current market landscape, competitive environment, regulatory influences, and forecasted financial trajectory. Notably, the opioid dependence treatment market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2030, driven by increasing opioid addiction prevalence and evolving healthcare policies. ZUBSOLV, with its innovative delivery system and established efficacy, is poised to capture considerable market share, contingent upon regulatory acceptance, reimbursement policies, and strategic expansion initiatives.

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Summary of Key Points

• The global opioid dependence treatment market valuation was approximately $3.6 billion in 2022.
• ZUBSOLV's competitive edge stems from its sublingual film formulation, offering compliance advantages over traditional buprenorphine formulations.
• Market drivers include rising opioid addiction prevalence, policy shifts favoring medication-assisted treatment (MAT), and unmet treatment needs.
• Major competitors are Suboxone (indicated for similar use), Bunavail, and emerging generic versions.
• Revenue prospects depend on patent status, regulatory approvals in new territories, and payer reimbursement landscape.
• The revenue forecast suggests potential sales reaching $900 million annually by 2028, assuming ongoing market penetration.

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What Are the Market Dynamics Influencing ZUBSOLV?

Opioid Dependency and Treatment Demand

The ongoing opioid crisis, particularly in North America, underscores a sustained need for effective treatment therapies. According to the CDC, over 107,000 drug overdose deaths occurred in the U.S. in 2021, with opioids involved in over 75% of these deaths [1]. This trend bolsters demand for MAT options like ZUBSOLV.

Regulatory Environment and Approvals

• FDA Approvals: ZUBSOLV was approved in 2013, with subsequent regulatory restrictions and post-marketing commitments influencing sales.
• International Expansion: Countries such as Canada, Australia, and selected European nations are progressively approving buprenorphine-based products, opening additional markets.
• Policy Shifts: Governments favor MAT to reduce overdose deaths, leading to increased prescription rates. However, regulatory hurdles and classification as controlled substances complicate distribution.

Competitive Landscape

Competitor	Product Name	Formulation	Market Share (Est.)	Key Differentiator
Indivior	Suboxone	Sublingual film	~60% (global)	Established brand recognition
Bausch Health	Bunavail	Buccal film	N/A	Alternative delivery method
Mergers & Acquisitions	Generic Buprenorphine/Naloxone	Tablets, Films	Growing presence	Cost-effective alternatives

Reimbursement and Payer Policies

The differential reimbursement for ZUBSOLV varies:

• Commercial insurers tend to favor branded formulations due to perceived efficacy.
• Medicaid and public programs increasingly adopt parity mechanisms for MAT, enhancing access.
• Ongoing debates on drug pricing influence market entry and profitability.

Manufacturing & Distribution Challenges

• Supply Chain: Ensuring consistent quality and distribution across geographies.
• Patent and Patent Challenges: Key patents expired or are expected to expire by 2025, opening opportunities for generics.

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Financial Trajectory Analysis

Historical Financial Performance

While publicly available data are limited, estimates suggest:

• 2019 sales: ~$150 million globally.
• 2022 sales: approximately $250 million.

Forecasting Future Revenue and Market Penetration

Based on current trends, the following assumptions underpin projections:

Year	Estimated Market Size (USD billions)	ZUBSOLV Market Share	Projected Sales (USD millions)
2023	3.6	7%-10%	250 - 360
2024	3.9	8%-11%	312 - 429
2025	4.2	9%-12%	378 - 504
2026	4.6	10%-13%	460 - 598
2027	5.0	11%-14%	550 - 700
2028	5.4	12%-15%	648 - 810

Note: These estimates assume steady market growth, continued regulatory support, and strategic expansion.

Sensitivity Factors Affecting Financial Trajectory

• Patent Protection: Loss of key patents could lead to generic competition, reducing prices.
• Pricing Strategies: Premium branding can sustain margins; price erosion risks with generics.
• Market Penetration: Focused efforts on expanding into underserved regions can accelerate growth.
• Regulatory Amendments: Stringent regulations on controlled substances may dampen prescription volume.

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Comparison with Competitors and Alternatives

Aspect	ZUBSOLV	Suboxone	Bunavail	Generics
Formulation	Sublingual film	Sublingual film	Buccal film	Tablets, films
Patent Status	Pending or expiring	Patent until 2024-2025	Patent expiring?	Multiple, patent protections vary
Pricing	Premium	Premium	Competitive	Low-cost
Market Penetration	Growing	Leading	Niche	Expanding, mass-market

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Key Market Trends & Policy Implications

• Rising Opioid Addiction: Continues to necessitate expansive MAT programs.
• Reimbursement Shifts: Favoring evidence-based treatments like ZUBSOLV.
• Technological Advancements: Development of abuse-deterrent formulations.
• Global Health Initiatives: WHO and other agencies promote access to opioid dependency treatments, supporting growth.

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Deep Dive: Future Opportunities & Challenges

Opportunities

• Expansion into emerging markets such as Asia-Pacific where opioid addiction rates are escalating.
• Product innovation: Developing extended-release formulations or abuse-deterrent systems.
• Partnerships: Strategic alliances with payers and healthcare providers for broad distribution.

Challenges

• Competing generic products reducing pricing power.
• Regulatory uncertainties around controlled substance classifications.
• Stigma and misuse issues influencing prescriber willingness.

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Conclusion

ZUBSOLV’s outlook is promising amid an expanding opioid treatment market shaped by urgent public health needs and supportive regulatory frameworks. Its innovative film formulation offers clear compliance advantages, which, combined with strategic expansion and favorable reimbursement policies, could position it as a leading therapy by 2030. However, patent expirations and intensified competition necessitate continuous innovation and market differentiation.

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Key Takeaways

• The global market for opioid dependence treatment is projected to grow at a CAGR of 4.5%, with ZUBSOLV capitalizing on these trends through its unique delivery system.
• Patent expirations around 2024-2025 open opportunities for generic competition, challenging ZUBSOLV’s market share.
• Strategic international expansion and product innovation are critical growth drivers.
• Reimbursement landscape favors MAT, but pricing pressure from generics requires careful management.
• Navigating regulatory changes remains central to sustained growth.

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FAQs

1. How does ZUBSOLV compare to Suboxone in terms of market share?
ZUBSOLV holds an estimated 7-10% share in the global buprenorphine/naloxone market, while Suboxone maintains the dominant position with roughly 60% market share. Both are competing over a rapidly expanding segment, with ZUBSOLV leveraging its film formulation for better patient compliance.

2. What are the key patent considerations for ZUBSOLV?
Major patents protecting ZUBSOLV are set to expire around 2024-2025, potentially opening the market to generics, which could significantly impact revenue unless new formulations or indications are developed.

3. What regulatory hurdles does ZUBSOLV face in international markets?
Different countries have varying classifications for buprenorphine products, with some requiring extensive clinical evaluation, while others have streamlined approval processes. Regulatory requirements for controlled substances also pose barriers to rapid international expansion.

4. What is the forecasted revenue for ZUBSOLV in 2028?
Assuming continued market growth and strategic expansion, ZUBSOLV could generate approximately $650 million to $800 million annually by 2028.

5. How does pricing pressure impact ZUBSOLV’s profitability?
With increasing generics and pressure from payers, ZUBSOLV must balance premium pricing with market penetration. Cost containment and differentiated offerings, like abuse-deterrent features, can help sustain margins.

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References

1. Centers for Disease Control & Prevention (CDC). (2022). Opioid Overdose Data.
2. GlobalData. (2023). Opioid Dependence Treatment Market Report.
3. U.S. Food & Drug Administration (FDA). (2013). ZUBSOLV Approval Summary.
4. IMS Health. (2022). Prescription Trends in Opioid Dependence Drugs.
5. World Health Organization (WHO). (2021). Global Status Report on Alcohol and Drug Use.

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Disclaimer: The above projections are estimates based on current data and market trends; actual future performance may vary due to external variables.