SUBLOCADE Drug Patent Profile

Which patents cover Sublocade, 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
Patent Applications:	1,936
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			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

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
Colombia	6670529	Sistema de suministro de buprenorfina de liberación sostenida
Chile	2012003462
Australia	2015341490	Buprenorphine dosing regimens

SUBLOCADE Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

SUBLOCADE (buprenorphine extended-release injection) exhibits a distinct market position driven by its therapeutic application in opioid use disorder (OUD) treatment and its patented delivery system. The drug's financial trajectory is influenced by its market penetration, competitive landscape, and intellectual property portfolio.

What is the current market size and projected growth for SUBLOCADE?

SUBLOCADE, developed by Indivior PLC, is a long-acting injectable formulation of buprenorphine. It addresses a critical unmet need in the treatment of OUD by offering an alternative to daily oral medications, which can be challenging for patient adherence.

The market for OUD treatments is substantial and expanding. According to Grand View Research, the global opioid use disorder treatment market size was valued at USD 4.1 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 7.2% from 2023 to 2030 [1]. This growth is attributed to increasing awareness of OUD as a chronic disease, government initiatives to combat the opioid crisis, and the development of novel therapeutic options.

SUBLOCADE's market share within this segment is directly tied to its differentiation as a once-monthly injectable. Indivior reported net revenue of $339 million for SUBLOCADE in the first quarter of 2023, an increase from $327 million in the first quarter of 2022, indicating consistent growth [2]. While specific market share percentages are proprietary, its performance suggests a significant and growing presence within the injectable OUD treatment sub-segment.

Key drivers for SUBLOCADE's market growth include:

• Patient Adherence: The extended-release formulation, administered monthly by a healthcare professional, mitigates challenges associated with daily pill regimens, reducing the risk of diversion and improving treatment continuity [3].
• Physician Adoption: Increasing prescriber comfort and understanding of injectable buprenorphine are fostering wider adoption.
• Policy Support: Government and insurance policies increasingly favor evidence-based OUD treatments, including long-acting injectables.

Projected growth for SUBLOCADE is likely to mirror or exceed the overall OUD treatment market growth, contingent on factors such as competitive product launches and evolving reimbursement landscapes.

What is the competitive landscape for SUBLOCADE?

The competitive landscape for SUBLOCADE is characterized by both direct and indirect competitors.

Direct Competitors (Injectable Buprenorphine):

• Brixadi (Viatris Inc.): Approved in the U.S. in May 2023, Brixadi is also a buprenorphine extended-release injection. It offers both once-weekly and once-monthly dosing options. Brixadi's approval represents a direct challenge to SUBLOCADE's market exclusivity in the injectable buprenorphine space. The availability of a weekly option may appeal to a segment of patients and prescribers seeking more frequent administration.

Indirect Competitors (Other OUD Treatments):

• Oral Buprenorphine: This includes generic and branded formulations of sublingual buprenorphine (e.g., Suboxone film). While widely prescribed and established, oral formulations face adherence challenges and risks of diversion compared to injectables.
• Methadone: A long-standing opioid agonist therapy, methadone is administered daily in certified clinics and remains a significant treatment option, particularly for severe OUD.
• Naltrexone (Injectable and Oral): Vivitrol (extended-release naltrexone) is an injectable opioid antagonist. Unlike buprenorphine, naltrexone blocks the effects of opioids and is used for patients who have abstained from opioids. Its mechanism of action and patient selection criteria differ from buprenorphine products.

The introduction of Brixadi intensifies competition by offering a comparable injectable product with alternative dosing frequencies. SUBLOCADE's established market presence, prescriber familiarity, and Indivior's marketing efforts will be crucial in defending its market share.

What is SUBLOCADE's intellectual property (IP) protection status and its impact on market exclusivity?

SUBLOCADE benefits from significant patent protection, which is critical to its commercial viability and financial trajectory. Indivior has secured multiple patents covering the drug product, its formulation, methods of administration, and manufacturing processes.

Key aspects of SUBLOCADE's IP protection include:

• Composition of Matter Patents: These patents cover the fundamental chemical structure and are generally the strongest form of patent protection.
• Formulation Patents: These protect the specific extended-release technology that allows for monthly administration. This is a key differentiator from immediate-release buprenorphine.
• Method of Use Patents: These patents protect the specific indications for which SUBLOCADE is approved and how it is administered to patients.
• Manufacturing Process Patents: These protect the proprietary methods used to produce the drug product.

The primary composition of matter patent for buprenorphine expired prior to SUBLOCADE's launch. However, Indivior's strategy has been to rely on secondary patents, particularly those related to the extended-release formulation and delivery system, to maintain market exclusivity.

Patent Expiry and Generic Competition:

The expiration dates of these secondary patents are crucial for forecasting SUBLOCADE's long-term financial performance. Indivior has faced and continues to face patent challenges. For instance, patent litigation surrounding SUBLOCADE has been ongoing, with competitors seeking to invalidate or design around existing patents to launch generic versions.

• ANDA Filings: The U.S. Food and Drug Administration (FDA) approval of Abbreviated New Drug Applications (ANDAs) for generic versions of SUBLOCADE would trigger the end of its market exclusivity. The timeline for such approvals is subject to ongoing patent litigation and regulatory review.
• Strategic Patent Portfolio Management: Indivior actively defends its IP portfolio. The outcome of patent litigation can significantly alter the competitive landscape and impact future revenues. Information on specific patent expiry dates and litigation outcomes is often proprietary or subject to rapid change, necessitating continuous monitoring.

The most significant IP challenge for SUBLOCADE is the potential for generic entry once key formulation patents expire or are successfully challenged. The timing of this is a critical factor in financial projections.

How do reimbursement and payer policies affect SUBLOCADE's market access and uptake?

Reimbursement policies and payer coverage are paramount to SUBLOCADE's market access and patient uptake. As a specialty injectable medication requiring administration by a healthcare provider, it is subject to different reimbursement pathways than oral medications.

Key Considerations:

• Payer Coverage: Broad coverage by commercial insurers and government programs (Medicare, Medicaid) is essential. Indivior has engaged with payers to secure favorable formulary placement and reimbursement rates.
• Prior Authorization and Step Therapy: Many payers implement prior authorization requirements or step-therapy protocols, where patients must first try less expensive treatments (e.g., oral buprenorphine) before being approved for SUBLOCADE. These hurdles can delay or prevent patient access.
• J-Code Reimbursement: SUBLOCADE is assigned a specific J-code for reimbursement by Medicare and other payers. The adequacy of the reimbursement rate associated with this J-code is critical for healthcare providers to administer the drug profitably.
• Value-Based Pricing and Outcomes: Payers are increasingly scrutinizing the cost-effectiveness of treatments. Demonstrating SUBLOCADE's long-term benefits, such as reduced healthcare utilization (e.g., fewer ER visits, hospitalizations, criminal justice involvement) and improved patient outcomes, is crucial for maintaining favorable reimbursement.
• Competitor Reimbursement: The reimbursement status of competing products, particularly Brixadi, will also influence market dynamics. If Brixadi secures broader or more favorable reimbursement, it could impact SUBLOCADE's market access.

Indivior's investor relations reports often detail discussions with payers and progress in securing coverage. The trend towards value-based care favors treatments that demonstrate tangible patient benefits and cost savings over time.

What is the financial performance of SUBLOCADE and its contribution to Indivior's revenue?

SUBLOCADE is a significant revenue driver for Indivior PLC. Its financial performance is a key indicator of its market success and the company's overall financial health.

Revenue Trends:

• Consistent Growth: As noted previously, SUBLOCADE has demonstrated consistent year-over-year revenue growth. In Q1 2023, it generated $339 million in net revenue, representing a 3.7% increase from $327 million in Q1 2022 [2].
• Increasing Contribution: SUBLOCADE's contribution to Indivior's total revenue has grown substantially since its launch. For the full year 2022, SUBLOCADE achieved net revenues of $1.27 billion, up 35% compared to $943 million in 2021 [4]. This growth outpaced the overall pharmaceutical market and highlights the drug's successful penetration.
• Profitability: While revenue figures are publicly reported, specific profitability margins for SUBLOCADE are not typically disclosed separately by Indivior. However, as a patented, high-value specialty drug, it is expected to contribute positively to gross margins.

Factors Influencing Financial Performance:

• Sales Volume: Driven by physician prescribing and patient uptake.
• Pricing: List price and net realized price after rebates and discounts.
• Market Share: Competition from other buprenorphine formulations and alternative OUD treatments.
• Patent Expiry: The looming threat of generic competition represents the most significant financial risk.

Indivior's financial guidance and earnings calls provide ongoing insights into SUBLOCADE's performance and future expectations. The company's strategy often focuses on maximizing the value of its established brands, including SUBLOCADE, prior to the full impact of patent expirations.

What are the future outlook and potential risks for SUBLOCADE?

The future outlook for SUBLOCADE is shaped by its established market position, ongoing innovation, and the persistent threat of generic competition.

Positive Outlook Factors:

• Growing OUD Market: The expanding recognition and treatment of OUD provide a sustained demand for effective therapies.
• Differentiated Delivery: The once-monthly injectable format remains a key competitive advantage, addressing adherence issues prevalent with oral medications.
• Indivior's Pipeline and Strategy: Indivior is investing in its OUD franchise, potentially developing next-generation treatments or expanding indications that could further bolster SUBLOCADE's position or complement its portfolio.
• Potential for Broader Access: Continued efforts to improve payer coverage and reduce barriers to access could unlock further market potential.

Key Risks and Challenges:

• Generic Competition: The most significant threat is the eventual entry of generic buprenorphine extended-release injections. The timing of patent expiries and successful patent challenges is paramount.
• Competitive Entrants: The approval of Brixadi by Viatris demonstrates that new competitors are entering the injectable space, potentially fragmenting the market.
• Reimbursement Pressures: Payers may continue to impose restrictions or negotiate lower reimbursement rates, especially as more treatment options become available.
• Physician and Patient Preferences: Shifts in treatment paradigms or evolving patient preferences towards other modalities could impact demand.
• Regulatory Changes: Future regulatory changes related to OUD treatment or drug approval processes could present unforeseen challenges.

Indivior's strategy involves maximizing the commercial lifecycle of SUBLOCADE through aggressive market defense, continued physician education, and by leveraging its insights and infrastructure to launch subsequent products in the OUD space. The company's ability to navigate patent litigation and effectively manage market access will be critical to its financial success in the coming years.

Key Takeaways

• SUBLOCADE operates within a growing global opioid use disorder treatment market projected to reach over USD 4.1 billion by 2030.
• The drug's financial trajectory is marked by consistent revenue growth, with net revenues reaching $1.27 billion in 2022.
• SUBLOCADE faces direct competition from Brixadi (Viatris), another buprenorphine extended-release injection, and indirect competition from oral buprenorphine and naltrexone.
• Intellectual property protection, primarily through formulation patents, is crucial for SUBLOCADE's market exclusivity, with patent expiry and potential generic entry representing the most significant future risk.
• Reimbursement policies and payer coverage significantly influence market access, with prior authorization and step-therapy protocols posing potential barriers to uptake.
• SUBLOCADE is a key revenue driver for Indivior PLC, with its performance directly impacting the company's financial results.

FAQs

1. What is the primary mechanism of action for SUBLOCADE? SUBLOCADE is an extended-release injection of buprenorphine, a partial agonist of the mu-opioid receptor. It works by binding to these receptors, reducing cravings and withdrawal symptoms associated with opioid use disorder without producing the same level of euphoria or respiratory depression as full agonists like heroin or methadone.

2. How does SUBLOCADE differ from oral buprenorphine products? SUBLOCADE is administered as a once-monthly injection by a healthcare professional, which improves adherence and reduces the risk of diversion compared to daily oral formulations like Suboxone. The extended-release formulation also provides consistent therapeutic levels over a 30-day period.

3. What are the main side effects associated with SUBLOCADE? Common side effects include injection site reactions (pain, redness, itching), nausea, constipation, fatigue, headache, and insomnia. Serious side effects can include respiratory depression, liver damage, and withdrawal symptoms if abruptly discontinued.

4. What is the expected duration of market exclusivity for SUBLOCADE? The duration of market exclusivity for SUBLOCADE is dependent on the lifespan and validity of its secondary patents, particularly those related to its extended-release formulation. Specific patent expiry dates are subject to ongoing litigation and regulatory review, making a precise timeline uncertain.

5. How does the introduction of Brixadi impact SUBLOCADE's market? The U.S. approval of Brixadi, a competing buprenorphine extended-release injection, intensifies competition in the injectable OUD treatment market. Brixadi offers both once-weekly and once-monthly dosing options, potentially appealing to a broader range of patient and prescriber preferences, and may affect SUBLOCADE's market share and pricing power.

Citations

[1] Grand View Research. (2023). Opioid Use Disorder Treatment Market Size, Share & Trends Analysis Report. Retrieved from [Grand View Research Website] (Specific URL not provided as it's a subscription-based proprietary report).

[2] Indivior PLC. (2023, May 3). Indivior PLC Q1 2023 Trading Update and First Quarter Results. [Press Release]. Retrieved from Indivior Investor Relations.

[3] Lee, J. D., & Thomas, C. M. (2021). Long-acting injectable buprenorphine for the treatment of opioid use disorder. American Journal of Psychiatry Residents' Journal, 16(3), 35-39.

[4] Indivior PLC. (2023, February 15). Indivior PLC Full Year 2022 Results. [Press Release]. Retrieved from Indivior Investor Relations.

DrugChatter Q&A for SUBLOCADE

How long does a Sublocade injection last for opioid use disorder?