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 thirteen 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:	13
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-five 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	10,592,168
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	12,622,904
Indivior	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 30, 2017		RX	Yes	Yes	10,558,394		Y
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	9,782,402		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
Australia	2011263478	Injectable flowable composition comprising buprenorphine
Brazil	112012031290	composição fluidificável injetável compreendendo buprenorfina
Canada	2801676	COMPOSITIONS (COMPOSITIONS)
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.
China	103079544	包含丁丙诺啡的可注射的可流动组合物 (Injectable flowable composition comprising buprenorphine)

Last updated: July 21, 2026

Sublocade (buprenorphine extended-release) market dynamics and financial trajectory: revenues, share shifts, and exclusivity/generic risk

Executive summary: Sublocade (buprenorphine extended-release injectable; Indivior) has sustained premium pricing and payer coverage over a multi-year period driven by opioid use disorder (OUD) maintenance demand, clinic-based administration, and a controlled-switch segment from sublingual buprenorphine. Near-term unit growth depends on access (prior authorization, step edits, and quantity controls), inventory discipline in the supply chain, and managed-care contracting. The long-run revenue ceiling is set by U.S. exclusivity and patent expiry risk around the proprietary product, including formulation and manufacturing process patents, plus any future generic/authorized generic entry pathway.

Because the prompt provides no geography, share baseline, or time window, this analysis is limited to structural market dynamics and the principal value drivers that govern financial trajectory for Sublocade. No market-size figures or revenue forecasts are included without cited, time-bounded financial data.

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How does Sublocade compete in opioid use disorder maintenance and what drives market share?

Featured snippet answer: Sublocade’s market share is driven by three forces: (1) payer coverage for monthly injectable buprenorphine, (2) patient and prescriber preference for adherence support versus daily sublingual therapy, and (3) distribution and clinic uptake in settings that can deliver supervised medication.

What are the key demand drivers for monthly injectable buprenorphine?

1. Adherence and retention mechanics

   • Monthly administration reduces missed-dose events relative to sublingual maintenance.
   • Retention is improved where patients face chaotic dosing or supervised clinic attendance.

2. Clinical conversion from sublingual buprenorphine

   • Sublocade converts a subset of patients stable on daily buprenorphine or those needing higher structure after adherence failure.
   • Conversion rate is constrained by induction stabilization, co-pay barriers, and local protocol adoption.

3. Managed-care utilization management

   • Utilization management commonly includes prior authorization and documented failure of sublingual therapy, or evidence of clinical instability/nonadherence.
   • Formularies increasingly steer “step-down” to lower-cost alternatives unless injectable access is secured.

What are the main competitive substitutes?

• Oral buprenorphine products (generic and branded), including sublingual films/tablets and combination products where relevant.
• Long-acting injectable alternatives (where present in the market and allowed on formularies), though Sublocade’s class position is typically strengthened by its established access footprint and payer contracts.

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What are the pricing and payer dynamics that determine Sublocade’s revenue trajectory?

Featured snippet answer: Sublocade’s financial trajectory tracks net price after rebates and coverage status more than list price. Contracting outcomes, rebate intensity, and patient co-pay support drive volatility quarter-to-quarter.

How do rebates, patient assistance, and net pricing interact

• Rebate structures tend to rise with formulary wins that broaden covered lives.
• Patient assistance can stabilize adherence by reducing patient out-of-pocket costs, supporting continuation therapy and reducing churn.
• Contracting leverage increases with volume commitments from pharmacy benefit managers or PBM-led formularies.

Where does access friction show up in P&L

• Prior authorization denials and delayed approvals can force therapy interruption, conversion delays, or switchbacks to sublingual products.
• Dispensing channel constraints (specialty pharmacy vs clinic administration workflows) can affect turnaround time and inventory positioning.
• Step edits and quantity controls reduce adoption velocity and cap near-term unit growth.

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When do Sublocade exclusivity and patent protections end, and how does that shape long-term revenue risk?

Featured snippet answer: The revenue risk profile for Sublocade is dominated by the date of U.S. patent expiry and any remaining exclusivity tied to the proprietary drug product. After those dates, generic and authorized generic entry becomes a function of Paragraph IV litigation outcomes and launch readiness.

How to think about “exclusivity versus patents” for an injectable

• Marketing exclusivity (e.g., regulatory exclusivity) can delay generic submission/approval timing.
• Patent estate can block commercial launch through:
  • Injunction risk during litigation
  • Settlement terms restricting launch dates
  • Narrow “carve-outs” allowing earlier entry of variants not covered

What patent categories matter most for Sublocade economics

• Product/formulation patents: cover composition and drug release characteristics.
• Manufacturing process patents: cover critical steps and scale-up controls for sterile injectable manufacture.
• Delivery system/device-related patents: cover injection components and handling method claims if present.
• Use patents (method-of-use): can limit generic labeling/indication if maintained.

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What is the generic and biosimilar risk for Sublocade, including Paragraph IV challenges?

Featured snippet answer: Sublocade is a small-molecule branded injectable with generic pathway risk in the U.S., and the dominant launch barrier is patent litigation and settlement scope. Biosimilar risk is not applicable in the standard sense because buprenorphine extended-release is not a biologic.

Paragraph IV exposure: what tends to move the stock-and-credit narrative

• A Paragraph IV filing typically signals a market-facing view that patents are either invalid, unenforceable, or not infringed.
• Automatic FDA stays and litigation/settlement timing decide whether launch happens at a date aligned to patent expiry or later.

What entry strategy is most common

• Generic injectable with a label that can be approved without requiring narrow patient-selection language.
• Authorized generic via brand-license partner, often with earlier availability but branded-level pricing pressure.

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How does Sublocade’s injection administration model affect distribution and gross margin?

Featured snippet answer: The clinic-orchestrated administration model concentrates logistical costs and shifts some friction away from traditional retail channels, but it also increases dependence on specialty distribution, inventory planning, and prescriber workflows.

Channel economics that matter

• Specialty distribution costs and ordering cadence
• Cold-chain or handling requirements (if applicable to the specific product handling protocols)
• Waste and reimbursement mechanics in clinical settings
• Contract pharmacy vs direct clinic purchasing differences

Inventory and supply chain

• Long-acting products have batch-level constraints.
• Revenue recognition and shipment timing can show volatility if there are:
  • Manufacturing downtime
  • Lot release delays
  • Allocation controls due to upstream capacity bottlenecks

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What litigation and settlement events historically shape buprenorphine product launch timing?

Featured snippet answer: Launch timing typically hinges less on FDA review cycle length and more on litigation and settlement scope that can delay generic competition well beyond the filing date.

What to monitor in future filings

• Court dockets and claim construction decisions affecting infringement scope
• Settlement “carve-out” terms, including:
  • Launch date
  • Label limitations
  • Shared supply or co-promotion agreements

How to interpret “design-around” activity

• Generic sponsors may attempt to alter formulation or manufacturing parameters.
• For long-acting injectables, minor changes can still trigger infringement if claims cover ranges or structural elements.

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What is the FDA regulatory status of Sublocade and how does it interact with competition?

Featured snippet answer: Sublocade’s FDA pathway governs when generic applicants can submit and when approvals can take effect, but patent and exclusivity remain the gating factors for U.S. launch.

Key regulatory considerations for long-acting injectables

• Manufacturing controls and sterility assurance are central to approval and post-approval inspections.
• Bioavailability and release profile expectations in controlled-release products can be a barrier to regulatory approval design around.

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How does Sublocade’s commercial performance compare with oral buprenorphine and other OUD maintenance options?

Featured snippet answer: Sublocade typically competes on adherence and retention economics rather than initial cost per day, with payer net-cost negotiations deciding whether injectable therapy displaces oral use.

Typical pattern in OUD maintenance switching

• Injectable uptake rises where:
  • Access programs reduce PA friction
  • Clinics implement standardized protocols
  • Patients face repeated adherence failure
• Oral products retain share where:
  • PBMs prefer lower acquisition cost
  • Co-pay exposure is manageable
  • Clinic administration capacity is limited

What determines the “share ceiling”

• Coverage breadth across geographies
• Patient churn and conversion persistence
• Contracting intensity and rebate pressure as more lives are enrolled

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What formulations and manufacturing patents protect Sublocade and raise generic/IP barriers?

Featured snippet answer: For extended-release injectables, the highest barrier usually comes from manufacturing process and drug-release related formulation claims tied to how the depot forms and releases buprenorphine over time.

Patent estate composition: the categories that matter for design-around

• Depot formation/process claims: cover mixing, dispersion, and solid formation steps.
• Sterile fill/finish parameters: cover filtration, filling, and handling.
• Release-rate related claims: cover target release kinetics, particle attributes, or component ratios.
• Stability and shelf-life claims: can complicate substitution if not cross-labeled.

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What geographic and payer sub-segment dynamics affect Sublocade revenues?

Featured snippet answer: Sublocade revenue outcomes are more sensitive to U.S. payer network contracting differences by region and specialty tier placement than to small changes in overall OUD prevalence.

Key sub-segments

• Medicaid vs commercial
  • Medicaid access varies by state PA rules and managed-care structure.
• Large PBM formularies
  • Broad formulary inclusion accelerates unit adoption but can drive higher rebate intensity.
• Integrated delivery networks
  • Systems with strong addiction medicine programs can standardize injectable therapy protocols.

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How strong is the patent estate for Sublocade and what does that imply for investment and licensing?

Featured snippet answer: The strength of Sublocade’s estate is measured by claim coverage breadth across formulation and manufacturing steps and by whether remaining enforceable claims survive typical generic litigation claim construction.

Investment-relevant indicators

• Number of independently enforceable patents in force covering:
  • Composition/formulation
  • Manufacturing steps
  • Critical release/depot formation characteristics
• Litigation posture and outcomes in comparable long-acting injectable cases
• Whether any patents are “thin” due to narrow claim scope (less likely to block entry)

Licensing implications

• If process patents are broad, licensing to future entrants may be the dominant path rather than full generic entry.
• If only narrow formulation claims remain, design-around becomes more plausible.

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Key Takeaways

• Sublocade’s financial trajectory is driven by net pricing after rebates, payer access, and conversion/retention from oral buprenorphine to monthly injectable dosing.
• Competition pressure primarily comes from oral buprenorphine alternatives and, over time, from generic or authorized generic long-acting buprenorphine once patent and exclusivity barriers fall.
• The dominant long-run revenue risk is U.S. patent expiry and any Paragraph IV litigation or settlement that determines launch timing.
• Supply chain execution and allocation discipline can create quarterly shipment volatility for long-acting depots.

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FAQs

1. How do prior authorizations typically affect Sublocade patient initiation and continuation?
2. What net-to-gross levers (rebates, patient assistance, contracting tiers) most influence Sublocade profitability?
3. Do manufacturing process patents for long-acting injectables create higher generic barriers than formulation-only patents?
4. What settlement terms are most likely to delay generic launch of an extended-release injectable?
5. How does changing formulary placement (preferred vs non-preferred) typically impact monthly injectable buprenorphine volumes?

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References (APA)

1. FDA. Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
3. U.S. Patent and Trademark Office. Patent Public Search. https://ppubs.uspto.gov/

DrugChatter Q&A for SUBLOCADE

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