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	9,687,454		Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	AB	RX	Yes	No	8,475,832		Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	AB	RX	Yes	No	9,687,454		Y
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012	AB	RX	Yes	Yes	11,135,216		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	022410-004	Aug 10, 2012	10,285,910
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012	9,931,305
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	8,017,150
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	8,603,514

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	2011093936	THIN FILM WITH NON-SELF-AGGREGATING UNIFORM HETEROGENEITY, METHOD FOR PRODUCING THE SAME, AND DRUG DELIVERY SYSTEM MADE THEREFROM
European Patent Office	1587504	Procédé pour l'obtention d'un film mince comprenant des actifs thermolabiles (Process for the manufacture of a thin film comprising heat sensitive actives)
European Patent Office	3326612	COMPOSITIONS PELLICULAIRES SUBLINGUALES ET BUCCALES (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS)
South Korea	20160029730	설하 및 구강 필름 조성물 (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS)

Market Dynamics and Financial Trajectory for SUBOXONE

Last updated: December 13, 2025

Executive Summary

SUBOXONE (buprenorphine/naloxone) remains a pivotal medication in opioid dependence treatment, with significant implications for pharmaceutical market dynamics. This analysis provides a comprehensive overview of recent trends, regulatory influences, revenue estimates, competitive landscape, and future projections. Amid ongoing opioid epidemic challenges, SUBOXONE's market trajectory is shaped by regulatory policies, patent statuses, generic entry, and evolving prescribing habits.

Introduction

SUBOXONE, approved by the FDA in 2002, combines buprenorphine, a partial opioid agonist, with naloxone, an antagonist designed to deter misuse. Positioned as a cornerstone in medication-assisted treatment (MAT), it commands a substantial share within the opioid addiction therapeutics market.

This report explores the market's current state, influencing factors, competitive environment, and forecasted growth patterns.

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What Are the Market Drivers for SUBOXONE?

Key Drivers	Details
Epidemiological Trends	Rising opioid addiction rates globally, especially in the U.S., propel demand for effective treatments. The CDC estimates over 100,000 drug overdose deaths in the U.S. in 2021, significantly driven by opioids [1].
Regulatory Endorsements	Increased support from health authorities, such as the DEA’s expansion of prescribing privileges under the Drug Addiction Treatment Act (DATA 2000), enhances access.
Expanded Prescriber Access	Policies allowing certified physicians to prescribe buprenorphine have widened treatment reach. As of 2022, over 230,000 clinicians are authorized to prescribe buprenorphine in the U.S. [2].
Shift Toward Medication-Assisted Treatment	The shift from abstinence-based approaches to MAT enhances SUBOXONE's utilization, driven by evidence of improved patient outcomes.
Insurance Coverage and Reimbursement	Favorable reimbursement policies boost accessibility, although price and formulary restrictions influence market penetration.

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What Are the Key Market Trends and Challenges?

Trend/Challenge	Impact & Details
Patent Expiry and Generic Entry	The original Suboxone product’s patent expiry spurred the emergence of generics, intensifying price competition and narrowing margins for brand-name manufacturers. The primary patent expired in 2023, with generics increasingly penetrating the market.
Increased Competition from Generics and Injectable Formulations	Companies like Teva, Natco Pharma, and Alvogen introduced generics; newer formulations, such as buprenorphine implants (e.g., Probuphine), are diversifying options.
Pricing Pressures	Price erosion due to generics reduces revenue per unit but potentially expands total market volume.
Policy and Regulatory Changes	The U.S. government has been promoting broader access; however, reimbursement rates, formulary restrictions, and prescribing limits impact sales. International policies vary, affecting global reach.
COVID-19 Pandemic Effects	Increased focus on telemedicine and take-home doses amplified access during the pandemic, though logistical challenges interrupted supply chains temporarily.

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How Do Patent and Regulatory Milestones Influence Market Trajectory?

Patent Timeline & Impact:

Year	Milestone	Market Implication
2002	FDA approval of SUBOXONE	Launch of brand product; dominant market position initially.
2016	Patent Litigation & Patent Expirations	Heightened competition; some patents upheld, others invalidated.
2023	Patent Expiry & Generic Approvals	Increased generic availability; downward pressure on prices.

Regulatory Influences:

• DEA Regulations: Expanded prescribing rights under the SUPPORT Act (2016) increased access, particularly for office-based treatment.
• State Policies: Varying state regulations influence prescribing patterns; some states restrict unqualified prescribers.
• International Authority Approvals: Approval processes differ globally, influencing market expansion.

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What Is the Financial Trajectory of SUBOXONE?

Revenue Estimates and Market Size

Parameter	2021 Estimate	2022 Trend	Projections (2023-2027)
Global Market Value	~$3.7 billion[3]	Slight decline in brand sales due to generics	Growing at CAGR of 6%, reaching ~$6.2 billion by 2027
U.S. Market Share	Approx. 70% of global revenue	Market share shifting towards generics	Expected to reduce for brand-name but increase in volume due to wider access
Average Price per Prescription	$200–$250 (brand), $80–$120 (generic)	Price erosion continues	Prices for generics expected to stabilize at lower levels
Number of Prescriptions (U.S.)	Over 8 million annually (2021)	Increasing with broader access	Forecasted CAGR of 4%, driven by expanding treatment initiatives

Profitability and Cost Factors

Factor	Impact
Manufacturing Costs	Lowered with generic competition; economies of scale.
Pricing Strategies	Brand firms adopting value-based pricing; generics driving down prices.
R&D and Marketing	Investment persists in developing formulations and expanding indications.
Reimbursement & Payer Policies	Critical in revenue realization; adherence to formulary inclusion enhances sales.

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How Do Market Segmentation and Geographic Trends Shape Outlook?

Region	Market Characteristics	Growth Potential
United States	Largest market; critical policy driver with extensive access	CAGR of 6% expected through 2027
Europe	Gradually adopting MAT strategies; regulatory hurdles	Moderate growth; focus on prescription access
Asia-Pacific	Emerging market with increasing opioid use; regulatory frameworks evolving	High growth potential owing to rising opioid misuse and treatment needs
Rest of World	Limited access; infrastructural challenges	Opportunities for expansion with policy development

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What Are the Competitive Dynamics and Future Outlooks?

Major Competitors	Market Share (~2022)	Key Differentiators	Strategic Moves
Indivior (Suboxone)	Estimated 60% before patent expiry	Established brand, comprehensive support programs	Diversifying into digital health tools, expanding formulations
Teva / Alvogen / Natco	Significant share in generics	Competitive pricing	Launching novel formulations, biosimilars
Other Emerging Brands	Incremental market share	Niche formulations, convenience	Focused marketing, international expansion

Future Market Drivers:

• Enhanced access through telemedicine
• Development of long-acting formulations (e.g., Buvidal, Probuphine)
• Integration of behavioral health and digital therapeutics
• Policy initiatives to further expand treatment access

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Comparing SUBOXONE to Alternative Therapies

Therapeutic Option	Type	Advantages	Limitations
Methadone	Full opioid agonist	Established efficacy, accessible via clinics	Strict regulation, daily visits
Naltrexone	Opioid antagonist	No abuse potential, suitable for motivated patients	Requires detoxification before initiation
LONG-ACTING Injectables	Buprenorphine implants/injectables	Reduces adherence issues	Higher upfront costs, limited availability

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Regulatory Policies Shaping Market Outcomes

Policy/Regulation	Impact	Key Dates/Details
DATA 2000 (2000)	Allowed office-based prescribing	Facilitated the rise of SUBOXONE
SUPPORT Act (2016)	Expanded prescribing authority	More clinicians authorized, increased access
FDA Approvals for Long-acting Formulations	Diversifies treatment options	Brixadi (2018), Probuphine (2016)
International Regulations	Varying degrees of access	European EMA approvals, etc.

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Key Takeaways

• The patent expiry of SUBOXONE has catalyzed a shift toward generic competition, reducing per-unit prices but expanding total market volume.
• Increased access and prescriptions are driven by supportive policies, expanded prescriber authorization, and the ongoing opioid crisis.
• The market is forecasted to grow at a CAGR of approximately 6% through 2027, reaching over $6 billion globally.
• Emerging formulations (long-acting injectables, implants) and digital health integrations are poised to reshape treatment paradigms.
• Pricing pressures from generics, reimbursement dynamics, and regulatory policies** will remain pivotal in shaping future revenue streams.

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FAQs

1. What are the implications of patent expiration on SUBOXONE's market?

Patent expiration in 2023 led to increased generic entry, significantly reducing drug prices while expanding access. Although this eroded profit margins for brand-name products, the overall market volume increased, presenting opportunities for competitors and new formulations.

2. How does regulatory policy influence the treatment landscape for SUBOXONE?

Regulations like the DEA’s expanded prescriber privileges and federal policies supporting MAT have broadened access. Conversely, restrictive prescribing limits or reimbursement barriers can constrain market growth.

3. What are the prospects for long-acting formulations of buprenorphine?

Long-acting injectables and implants (e.g., Sublocade, Probuphine) are expected to grow, addressing adherence issues and providing alternative treatment options. These formulations can command higher pricing, benefiting manufacturers.

4. How does the international market differ from the U.S. in terms of SUBOXONE?

Global adoption varies; European countries have more restrictive regulations, but growing acceptance. Emerging markets, especially in Asia-Pacific, show substantial growth potential driven by rising opioid misuse and evolving health policies.

5. What factors threaten the future market expansion of SUBOXONE?

Potential threats include policy reversals restricting prescribing, regulatory hurdles for new formulations, and pricing pressures from generics. Additionally, emergent non-opioid therapies and societal shifts in addiction treatment could impact demand.

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References

[1] Centers for Disease Control and Prevention (CDC). (2022). 2021 OVERDOSE death data.
[2] Substance Abuse and Mental Health Services Administration (SAMHSA). (2022). Buprenorphine Data.
[3] Grand View Research. (2022). Opioid Addiction Treatment Market Size, Share & Trends analysis report.