SUBOXONE Drug Patent Profile

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

Suboxone is a drug marketed by Indivior and is included in two NDAs. There are three patents protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in SUBOXONE 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 Suboxone

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

Summary for SUBOXONE

International Patents:	32
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	100
Drug Prices:	Drug price information for SUBOXONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUBOXONE
What excipients (inactive ingredients) are in SUBOXONE?	SUBOXONE excipients list
DailyMed Link:	SUBOXONE at DailyMed

See drug prices for SUBOXONE

See drug sales revenues for SUBOXONE

Recent Clinical Trials for SUBOXONE

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

Sponsor	Phase
Indivior Inc.	PHASE2
Erin Winstanley	PHASE4
National Institute on Drug Abuse (NIDA)	PHASE4

See all SUBOXONE clinical trials

Pharmacology for SUBOXONE

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

Paragraph IV (Patent) Challenges for SUBOXONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUBOXONE	Sublingual Film	buprenorphine hydrochloride; naloxone hydrochloride	12 mg/3 mg	022410	1	2013-05-14
SUBOXONE	Sublingual Film	buprenorphine hydrochloride; naloxone hydrochloride	2 mg/0.5 mg* and 8 mg/2 mg	022410	1	2012-10-15
SUBOXONE	for Injection	buprenorphine hydrochloride; naloxone hydrochloride	500 mg/vial	020733	2	2009-01-26

US Patents and Regulatory Information for SUBOXONE

SUBOXONE is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	AB	RX	Yes	No			Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	AB	RX	Yes	No			Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	AB	RX	Yes	No			Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012	AB	RX	Yes	Yes			Y

Expired US Patents for SUBOXONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010

International Patents for SUBOXONE

When does loss-of-exclusivity occur for SUBOXONE?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Denmark

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Peru

Russian Federation

Singapore

South Africa

South Korea

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 SUBOXONE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2011050394	MULTI-LAYER FILM HAVING UNIFORM CONTENT
Canada	2771089	COMPOSITIONS PELLICULAIRES SUBLINGUALES ET BUCCALES (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS)
European Patent Office	1968558	FILMS AU PH RÉGULÉ DESTINÉS À ADMINISTRER DES AGENTS ACTIFS (PH MODULATED FILMS FOR DELIVERY OF ACTIVES)
Singapore	178265	SUBLINGUAL AND BUCCAL FILM COMPOSITIONS

Market Dynamics and Financial Trajectory for SUBOXONE

Last updated: November 20, 2025

Introduction

SUBOXONE (buprenorphine and naloxone) stands as a prominent pharmaceutical intervention in the treatment of opioid use disorder (OUD). Approved by the FDA in 2002, it has become integral to addiction management due to its efficacy in reducing opioid cravings and preventing relapse. As the opioid epidemic persists globally, understanding the market dynamics and financial trajectory of SUBOXONE is essential for stakeholders including pharmaceutical companies, healthcare providers, policymakers, and investors.

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Market Overview

The global opioid dependence treatment market, dominated by medications like SUBOXONE, was valued at approximately USD 4.97 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 6.2% through 2030 [1]. The primary drivers include burgeoning awareness of opioid addiction, expanding access to medication-assisted treatment (MAT), and regulatory shifts favoring outpatient management.

In the U.S., the market is particularly mature and competitive, comprising key players such as Indivior (manufacturer of SUBOXONE) and Teva Pharmaceuticals, alongside generics producers. The U.S. accounted for the majority share, driven by high opioid misuse prevalence and expansive insurance coverage. International markets, notably Europe and parts of Asia, are witnessing increasing adoption amidst rising mental health awareness efforts.

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Market Dynamics

1. Epidemic-Driven Demand

The escalating opioid crisis in North America has significantly amplified the demand for effective treatment regimens. According to the CDC, over 107,000 drug overdose deaths occurred in the U.S. in 2021, a substantial proportion linked to opioids [2]. This public health emergency has catalyzed government initiatives, including federal funding and policy reforms, enhancing access to medications like SUBOXONE.

2. Regulatory Environment

Regulatory policies substantially influence market dynamics. The Drug Enforcement Administration (DEA) classifies buprenorphine as a Schedule III controlled substance, permitting office-based prescribing under the Drug Addiction Treatment Act of 2000 (DATA 2000). Recent efforts to reduce prescribing barriers include the SUPPORT for Patients and Communities Act (2018), which eased restrictions on buprenorphine prescribing, thereby expanding access.

However, policy debates linger regarding prescription limits and misuse prevention—factors that can restrict market growth. In some jurisdictions, stringent regulations and stigma continue to impede widespread utilization.

3. Competitive Landscape and Generics

Initially protected by patents, SUBOXONE’s patent expiration in the U.S. in 2023 opened avenues for generic formulations, intensifying competition and driving down prices [3]. The entry of generics has led to increased affordability and wider adoption but also pressure on brand-name revenues.

Indivior, the original manufacturer, has responded by diversifying its portfolio to include extended-release formulations and digital therapeutics. Additionally, the market is seeing innovations like injectable buprenorphine (Sublocade), aimed at improving adherence.

4. Manufacturing and Supply Chain Factors

Manufacturing capacities, raw material availability, and supply chain stability significantly impact market supply and pricing. The COVID-19 pandemic exposed vulnerabilities, prompting companies to reassess risk mitigation strategies to ensure consistent drug supply.

5. Reimbursement and Insurance Coverage

Insurance coverage, Medicaid expansion, and public health programs are pivotal in maintaining affordability and accessibility. The favorable reimbursement landscape in the U.S. supports sustained demand, though disparities still exist, particularly among underserved populations.

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Financial Trajectory

1. Revenue Trends

Indivior’s revenue from SUBOXONE peaked pre-patent expiry on its brand-name product, with annual sales reaching approximately USD 1.2 billion in 2020. Post-patent loss, revenue trajectory has faced downward pressure due to generic competition, with sales declining by an estimated 15–20% annually since 2021 [4].

The global market’s growth prospects are substantially influenced by regulatory approval of new formulations and geographic expansion. Additionally, increased funding for opioid treatment programs can bolster revenue streams.

2. Profitability and Cost Dynamics

The shift towards generics has sharply reduced per-unit prices, squeezing profit margins for original manufacturers. Meanwhile, costs associated with compliance, manufacturing, and marketing remain high. Companies investing in research & development for formulations like long-acting injectables (e.g., Sublocade) aim to buffer declining revenues by capturing premium pricing segments.

3. Investment & Valuation Perspectives

Investors are viewing SUBOXONE’s market from both a declining brand perspective and an innovation pipeline approach. The valuation of Indivior, for example, hinges on its pipeline of extended-release formulations and digital therapeutic integrations, which promise higher margins and increased market share.

4. Future Revenue Projections

Based on current trends, global revenues for SUBOXONE and related formulations are expected to stabilize in the short term but grow moderately in emerging markets where opioid dependency treatment infrastructure improves. The anticipated CAGR for post-patent formulations is estimated at approximately 4-5% through 2030, driven chiefly by innovation and expanded access [1].

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Market Challenges and Opportunities

Challenges

• Regulatory and Policy Uncertainties: Potential restrictions on prescribing or pricing controls could impede growth.
• Stigma: Persistent social stigma around addiction hampers access to treatment.
• Patent Expiry and Generic Competition: Reduced pricing power threatens margins.
• Misuse and Diversion Risks: Increasing concerns around diversion can lead to tighter controls and reduced prescribing.

Opportunities

• Innovative Delivery Systems: Long-acting injectable formulations and implantable devices improve adherence and reduce diversion.
• Expanding Global Access: Emerging markets present substantial growth potential, as opioid misuse and treatment awareness grow.
• Digital Therapeutics and Monitoring: Integration of digital health tools can enhance treatment outcomes, fostering premium pricing.

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Strategic Outlook

The long-term financial trajectory of SUBOXONE is characterized by a transition from high-margin proprietary sales to a broader, more competitive landscape dominated by generics. Companies that invest in formulation innovations and digital health integration are better positioned to sustain profitability. Policymaker support for expanding access and reducing stigma will further influence market expansion.

The increasing adoption of extended-release formulations and increasing global awareness hold promise for revenue growth, despite the challenges posed by patent cliffs and regulatory hurdles. Strategic diversification into related treatment modalities and partnerships will be essential for stakeholders seeking to capitalize on the evolving market.

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Key Takeaways

• The opioid crisis continues to drive demand for medications like SUBOXONE, but regulatory and social challenges affect market growth.
• Patent expirations have intensified competition; generics are significantly reducing costs and market prices.
• Innovation in delivery formats—specifically long-acting injectables—and digital therapeutics are critical to sustaining profitability.
• Emerging markets offer promising growth prospects due to increasing opioid misuse and expanding healthcare infrastructure.
• Strategic investments in R&D, regulatory navigation, and access expansion are vital for long-term financial success.

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FAQs

1. How has patent expiry impacted SUBOXONE’s market share?
Patent expiry in 2023 led to increased generic competition, significantly reducing brand-name sales and forcing original manufacturers to innovate or diversify their product offerings.

2. What are the main types of formulations available for SUBOXONE?
Originally available as sublingual films, SUBOXONE’s formulation landscape now includes generic sublingual tablets, extended-release injectable formulations (e.g., Sublocade), and potential implantable devices in development.

3. How do regulatory policies influence SUBOXONE’s market dynamics?
Policies such as prescribing restrictions, scheduling classifications, and funding initiatives directly affect access and utilization. Eased regulations expand market potential, while strict controls can slow growth.

4. What investment strategies are suitable for stakeholders in the SUBOXONE market?
Investors should focus on companies innovating in long-acting formulations and digital therapeutics, monitor regulatory developments, and assess exposure to emerging markets with rising opioid treatment needs.

5. What are the key opportunities for growth in the global market?
Expanding access in Asia, Latin America, and Africa; innovating with digital health tools; and developing improved delivery methods present significant avenues for growth.

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References

[1] MarketsandMarkets. (2022). Opioid Dependence Treatment Market.
[2] CDC. (2022). Drug Overdose Deaths.
[3] U.S. Patent and Trademark Office. (2023). Patent Expiry and Generic Entry.
[4] Indivior FY2021 Earnings Report.