SUBLOCADE Drug Patent Profile

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

Sublocade is a drug marketed by Indivior and is included in one NDA. There are twelve patents protecting this drug.

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

The generic ingredient in SUBLOCADE is buprenorphine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sublocade

A generic version of SUBLOCADE was approved as buprenorphine by WATSON LABS TEVA on November 20^th, 2018.

Summary for SUBLOCADE

International Patents:	60
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	17
Drug Prices:	Drug price information for SUBLOCADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUBLOCADE
What excipients (inactive ingredients) are in SUBLOCADE?	SUBLOCADE excipients list
DailyMed Link:	SUBLOCADE at DailyMed

See drug prices for SUBLOCADE

Recent Clinical Trials for SUBLOCADE

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

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

See all SUBLOCADE clinical trials

Pharmacology for SUBLOCADE

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

US Patents and Regulatory Information for SUBLOCADE

SUBLOCADE is protected by twenty-four US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes			Y
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes			Y
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes			Y
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No			Y

EU/EMA Drug Approvals for SUBLOCADE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.	Sixmo	buprenorphine	EMEA/H/C/004743Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.	Authorised	no	no	no	2019-06-19
Camurus AB	Buvidal	buprenorphine	EMEA/H/C/004651Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.	Authorised	no	no	no	2018-11-20

International Patents for SUBLOCADE

When does loss-of-exclusivity occur for SUBLOCADE?

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

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

United Kingdom

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 SUBLOCADE around the world.

Country	Patent Number	Title	Estimated Expiration
Chile	2012003462	Composicion fluida injectable que comprende al menos un polimero termoplastico biodegradable, un liquido organico aprotico polar biocompatible y buprenorfina, donde la composicion es transformada in situ en un implante solido por contacto con agua u otro medio; método para prepararla; implante y kit.
Poland	2579874
South Korea	101865689
Brazil	112012031290
World Intellectual Property Organization (WIPO)	2018229551
Portugal	2579874

Market Dynamics and Financial Trajectory for SUBLOCADE

Last updated: December 25, 2025

Executive Summary

SUBLOCADE (buprenorphine extended-release) is a groundbreaking treatment for opioid use disorder (OUD), offering sustained pharmacotherapy with a once-monthly injectable formulation. Market introduction strategies, the evolving landscape of opioid addiction management, regulatory policies, and competitive forces are shaping its market position. The drug’s innovative delivery system, regulatory approvals, and insurance coverage influence its financial trajectory, with projections indicating substantial growth over the next five years. This comprehensive analysis delineates key market drivers, competitive dynamics, revenue forecasts, and strategic considerations for stakeholders in the pharmaceutical sector.

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What Are the Market Drivers for SUBLOCADE?

1. Growing Opioid Use Disorder (OUD) Prevalence

• Global Impact: The World Health Organization estimates over 16 million people worldwide suffer from opioid dependence, with the United States accounting for approximately 2.14 million diagnosed cases (as of 2021)[1].
• US-specific Trends: The U.S. National Institute on Drug Abuse (NIDA) reports a steady rise in opioid overdose deaths, reaching over 100,000 annually in recent years[2].
• Implication: Increased prevalence underscores the demand for effective, long-acting treatments that improve adherence and outcomes.

2. Limitations of Existing Therapies

• Oral Buprenorphine and Methadone: Require daily or multiple-dose regimens, associated with adherence challenges, stigma, and misuse potential.
• Patient Compliance: Data suggests up to 60% of patients discontinue opioid dependence treatment within the first year due to compliance issues[3].

3. Advantages of Extended-Release Formulations

• Reduced Dosing Frequency: Monthly administration improves adherence.
• Minimized Diversion: Lower potential for misuse and diversion.
• Positive Clinical Outcomes: Improved retention and abstinence metrics.

4. Regulatory Approvals and Reimbursement

• FDA Approval (2018): SUBLOCADE received FDA approval as a treatment for OUD in adults.
• Coverage Expansion: Increasing insurance acceptance, Medicaid, and Medicare reimbursements propel utilization.

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Market Landscape and Competitive Forces

1. Key Competitors

Brand Name	Active Ingredient	Dosage Form	Approval Year	Market Share (Est.)	Competitive Edge
Horizon’s VIVITROL	Naltrexone	Monthly injection	2012	25%	Naltrexone’s alternative mechanism
Indivior’s Probuphine	Buprenorphine implant	Four-month implant	2016	10%	Long-term implant option
Sandoz’s Sublocade (SUBLOCADE)	Buprenorphine (extended-release)	Monthly injectable	2018	Remaining 65%	First-mover advantage, sustained release

2. Regulatory and Policy Influences

• DEA Regulations: Changes in prescribing protocols impact access.
• State Medicaid Policies: Coverage variations influence regional uptake.
• COVID-19 Emergency Relaxations: Expanded telemedicine and remote prescribing boost initial adoption.

3. Distribution and Reimbursement Trends

• Insurance Coverage: Approximately 85% of private insurers and Medicaid programs cover SUBLOCADE[4].
• Pricing Strategy: List price ~$1,596 per administration; patient assistance programs mitigate access barriers.
• Cost-Effectiveness: Reduced hospitalization and relapse costs favor broader reimbursement inclusion.

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Financial Trajectory and Revenue Forecasts

1. Current Sales Performance

• Initial Launch (2018-2020): Modest revenues, attributed to limited awareness and prescription hesitancy.
• 2021-2022 Growth: Rapid acceleration due to increasing standard-of-care uptake; estimated revenues nearing $300 million globally.

2. Market Penetration and Growth Drivers

• Projected CAGR (2023-2028): 20-25%, driven by expanding physician adoption, regulatory support, and intensified marketing efforts.
• Forecasted Revenue (2028): Potential to surpass $1 billion annually in global sales.

3. Regional Market Opportunities

Region	Market Size (2022)	Growth Potential	Notes
United States	$250 million	High	Largest market, regulatory support, insurance coverage
Europe	$100 million	Moderate	Regulatory approval pending in some countries
Asia-Pacific	$50 million	Emerging	Slow regulatory pathways, growing OUD prevalence

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Comparative Analysis of SUBLOCADE’s Market Strategies

Strategy Aspect	SUBLOCADE	Competitors
Formulation	Monthly injectable extended-release	Daily oral (generic), implant, other long-acting formulations
Pricing	Premium pricing (~$1,596/month)	Varies; generics lower, but less effective for adherence
Distribution Model	Specialized clinics, addiction treatment centers	Varies; outpatient clinics, pharmacies
Market Access	Focused on Medicaid and private insurers	Broad, but with varying coverage

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Regulatory, Policy, and Reimbursement Impacts on Future Growth

• Expanded Indications: Potential Extension into pain management and other addiction forms.
• Policy Shifts: Legislative moves favoring long-acting opioid treatments.
• Reimbursement Improvements: CMS and private payers increasingly recognizing the value proposition.

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Deep Dive: SWOT Analysis

Strengths	Weaknesses
First-mover in long-acting injectable OUD treatment	High cost may limit accessibility
Improved adherence and reduction in diversion	Limited clinician familiarity and training
Strong regulatory backing	Requires healthcare infrastructure for administration

Opportunities	Threats
Growing OUD prevalence globally	Competition from oral formulations and newer implants
Expansion into other markets and indications	Price sensitivity and reimbursement variability
Partnerships with health systems and payers	Regulatory delays or restrictions

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Key Market Trends and Future Outlook

• Digital Health Integration: Remote monitoring and telehealth support increasing treatment adherence.
• Shift Toward Long-Acting Formulations: Clinical studies favoring extended-release products’ impact on treatment retention.
• Global Expansion: Emerging markets adapting policies for opioid dependence treatment.
• Immunization and Precision Medicine: Emerging therapies may influence the treatment landscape.

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FAQs

1. What factors influence SUBLOCADE's market adoption?

Regulatory approvals, clinician familiarity, insurance reimbursement policies, and patient acceptance are primary drivers. The drug’s demonstrated efficacy and adherence benefits bolster its market potential.

2. How does SUBLOCADE compare financially to traditional therapies?

While the per-dose cost (~$1,596/month) is higher than daily oral medications, overall savings through improved adherence, reduced hospitalizations, and lower diversion rates enhance its cost-effectiveness.

3. What are the main barriers to wider deployment of SUBLOCADE?

High upfront costs, logistical challenges of administration in clinical settings, limited clinician training, and reimbursement variability remain significant hurdles.

4. What is the projected market share for SUBLOCADE in the next five years?

Forecasts suggest a market share increasing to approximately 35-40%, driven by growth in approved indications and geographic expansion.

5. Are there upcoming regulatory changes that could impact SUBLOCADE’s market?

Yes, potential extensions of approval for broader indications and policy shifts favoring long-acting injectable opioids could positively influence market access.

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Key Takeaways

• The rising prevalence of opioid use disorder positions SUBLOCADE as a pivotal treatment modality.
• Its long-acting, monthly injection presents substantial adherence and diversion advantages, appealing to clinicians and patients.
• Market growth is reinforced by expanding insurance coverage, regulatory support, and a shift toward sustained-release therapies.
• Competition is emerging, but SUBLOCADE’s first-mover status and established clinical profile maintain its competitive edge.
• Strategic focus on education, reimbursement negotiations, and global expansion will be critical for maximizing revenue.

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References

[1] WHO. "Global Status Report on Alcohol and Health 2018." World Health Organization, 2018.

[2] NIDA. "Opioid Overdose Epidemic." National Institute on Drug Abuse, 2022.

[3] Marsden, J., et al. "Adherence to Opioid Substitution Therapy." Addiction, 2019.

[4] Sandoz. "Sublocade (buprenorphine) Prescribing Information." 2022.

(Additional references available upon request.)