SUBLOCADE Drug Patent Profile

Which patents cover Sublocade, and what generic alternatives are available?

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
Lifespan	PHASE4
National Institute on Drug Abuse (NIDA)	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	8,921,387		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	10,646,484
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	9,782,402		Y
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	9,498,432		Y
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No	9,827,241		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
Japan	2013533230
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.
European Patent Office	3638240	PROCÉDÉS DE TRAITEMENT D'UN TROUBLE LIÉ À L'USAGE D'OPIOÏDES (METHODS TO TREAT OPIOID USE DISORDER)
United Kingdom	2481018	Buprenorphine sustained release system
Australia	2011263478	Injectable flowable composition comprising buprenorphine
Russian Federation	2607498	ЖИДКОТЕКУЧИЕ КОМПОЗИЦИИ ДЛЯ ИНЪЕКЦИЙ, ВКЛЮЧАЮЩИЕ БУПРЕНОРФИН (THIN-FLUID COMPOSITION FOR INJECTIONS CONTAINING BUPRENORPHINE)

Market Dynamics and Financial Trajectory for SUBLOCADE (Buprenorphine Extended-Release)

Last updated: July 27, 2025

Introduction

SUBLOCADE, a landmark development in the treatment of opioid use disorder (OUD), is an extended-release buprenorphine injection produced by Indivior. Approved by the FDA in 2018, it addresses critical barriers in OUD management by enabling monthly dosing, thereby improving adherence and reducing treatment stigma. Analyzing its market dynamics and financial trajectory provides insights into its growth potential amidst evolving healthcare and regulatory landscapes.

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Market Overview

The global opioid addiction therapy market is projected to reach USD 8.2 billion by 2027, growing at a CAGR of approximately 6.5% (Source: Fortune Business Insights). The rise in opioid misuse and overdose deaths, especially in North America, accelerates demand for effective treatments such as SUBLOCADE.

Target Patient Population

OUD affects over 10 million individuals worldwide, with a significant burden in the United States where over 2 million people suffer from opioid dependency (Source: CDC). PATIENTS prefer long-acting formulations like SUBLOCADE, which offer convenience over daily medication regimens, potentially reducing treatment discontinuation.

Competitive Landscape

While methadone and oral buprenorphine are dominant, their adherence issues drive demand for long-acting injectables. Alternatives to SUBLOCADE include:

• Sublocade (also by Indivior), a comparable buprenorphine monthly injection.
• Probuphine (implant), providing six months of therapy.
• Emerging competitors integrating novel delivery systems.

Substitutes and competitors shape the market, but SUBLOCADE's unique positioning is reinforced by regulatory approvals and clinical efficacy data.

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Market Dynamics

Regulatory Environment

Regulatory agencies like the FDA and EMA facilitate access through approvals and guidance on abuse-deterrent formulations. The specialized prescribing framework for buprenorphine limits large-scale distribution but also encourages targeted marketing strategies. The recent expansion of prescribing rights under the Comprehensive Addiction and Recovery Act (CARA) in the U.S. enhances market access.

Pricing and Reimbursement

Pricing strategies for SUBLOCADE typically range between USD 1,000 and USD 1,500 per injection (retail). Reimbursement coverage varies across payers, with Medicaid and private insurers increasingly including SUBLOCADE as a covered benefit due to its potential to reduce overall healthcare costs by decreasing misuse and hospitalization.

Prescriber Adoption and Patient Acceptance

Physician familiarity and comfort with long-acting formulations are improving, driven by positive clinical trial outcomes demonstrating reduced relapse rates. Patient preference for less frequent dosing bolsters demand. Barriers remain, including clinician training gaps and stigma, which impede rapid expansion.

Manufacturing and Supply Chain

Indivior's global manufacturing capacity and strategic supply chain partnerships support scalability. COVID-19 pandemic disruptions challenged manufacturing logistics but also underscored the importance of reliable delivery mechanisms for injectable treatments.

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Financial Trajectory

Revenue Generation

Since its launch, SUBLOCADE has demonstrated consistent revenue growth, driven primarily by increased prescribing in the U.S. and expanding markets globally. In FY2022, Indivior reported SUBLOCADE revenues of approximately USD 400 million, representing over 30% of the company's total sales—highlighting its strategic importance.

Market Penetration and Growth Drivers

• Increased adoption among prescribers: Initiatives include training programs, patient awareness campaigns, and collaborations with addiction centers.
• Expanding indications: Current labels specifically target OUD; future expansion to other indications such as chronic pain could elevate revenues.
• Geographical Expansion: Emerging markets, including Europe, Latin America, and Asia, present significant growth opportunities due to rising addiction trends and unmet needs.

Pricing Trends and Profitability

While premium-priced, SUBLOCADE benefits from relatively high gross margins (estimated >80%), given manufacturing efficiencies and premium pricing. Reimbursement negotiations influence net realized prices, with payers increasingly recognizing its cost-effectiveness.

Investment in R&D and Pipeline

Indivior continues investing in pipeline products—both specialized formulations and combination therapies—to sustain future growth. R&D expenditures are focused on reducing treatment frequency further and improving delivery mechanisms.

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Challenges and Risks

• Regulatory Hurdles: Changing regulations or restrictions on buprenorphine prescribing could affect sales.
• Market Competition: Entry of generic formulations or alternative long-acting injectables may compress margins.
• Reimbursement and Pricing Pressure: Payers seeking cost-containment may negotiate better rates or favor competing therapies.

Opportunities for Growth

• Global Rollout: Increasing adoption in underserved regions with rising OUD prevalence.
• Therapeutic Advances: New formulations with extended duration (e.g., 6 months or more) can redefine market penetration.
• Holistic Treatment Integration: Combining SUBLOCADE with psychosocial interventions could improve treatment outcomes and bolster demand.

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Conclusion

SUBLOCADE’s market dynamics are shaped by the growing global burden of opioid dependence, evolving regulatory frameworks, and competitive innovations in addiction therapy. Its financial trajectory remains favorable, underpinned by increasing prescriptions driven by clinical advantages and supportive reimbursement policies. However, sustained growth depends on strategic market expansion, competitive positioning, and navigating regulatory and pricing challenges.

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Key Takeaways

• Robust Growth Potential: The rising prevalence of OUD globally and increasing acceptance of long-acting injectable therapies position SUBLOCADE as a key growth driver for Indivior.
• Market Expansion Opportunities: Geographical diversification and potential label extensions can unlock significant revenue streams.
• Competitive Landscape: Maintaining a competitive edge necessitates continuous R&D investment and strategic partnerships.
• Pricing and Reimbursement: Negotiating favorable reimbursement policies remains critical amid price-sensitive markets.
• Innovation and Pipeline Development: Future formulations and indications will determine long-term market relevance.

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FAQs

1. What differentiates SUBLOCADE from other buprenorphine therapies?
   SUBLOCADE offers a monthly injectable formulation that simplifies adherence, reduces diversion risk, and improves treatment retention compared to daily oral or implant options.

2. How does regulatory approval impact SUBLOCADE’s market growth?
   Regulatory endorsements facilitate wider prescribing, insurance coverage, and international expansion, directly influencing revenue and market share.

3. What are the main challenges facing SUBLOCADE’s expansion?
   Barriers include clinician familiarity, stigma around opioid treatments, reimbursement negotiations, and potential competition from generic formulations or other long-acting therapies.

4. Can SUBLOCADE be used for indications beyond opioid use disorder?
   Currently approved specifically for OUD, future research could explore its application in chronic pain management or other related areas.

5. How does the pricing of SUBLOCADE affect its market penetration?
   While premium-priced, its cost-effectiveness in reducing healthcare utilization supports favorable reimbursement, although price sensitivity remains a factor in some markets.

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Sources

1. Fortune Business Insights. (2022). Opioid addiction treatment market size, share, growth.
2. Centers for Disease Control and Prevention (CDC). (2022). Opioid overdose data.
3. Indivior Annual Report (2022). Financials and corporate strategy overview.
4. FDA. (2018). Approval documentation for SUBLOCADE.
5. Global Market Insights. (2022). Addiction therapeutics market trends.