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Last Updated: October 31, 2024

SUBLOCADE Drug Patent Profile


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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 fifty-nine patent family members in thirty-one countries.

The generic ingredient in SUBLOCADE is buprenorphine. There are twenty-nine drug master file entries for this compound. Nine 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 20th, 2018.

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Drug patent expirations by year for SUBLOCADE
Drug Prices for SUBLOCADE

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Recent Clinical Trials for SUBLOCADE

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

SponsorPhase
Royal Victoria Hospital, CanadaPhase 4
National Institute on Drug Abuse (NIDA)Phase 4
Wake Forest University Health SciencesPhase 2

See all SUBLOCADE clinical trials

Pharmacology for SUBLOCADE
Drug ClassPartial Opioid Agonist
Mechanism of ActionPartial Opioid Agonists

US Patents and Regulatory Information for SUBLOCADE

SUBLOCADE is protected by twenty-four US patents.

Patents protecting SUBLOCADE

Injectable flowable composition comprising buprenorphine
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Patented Use: TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Injectable flowable composition comprising buprenorphine
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Injectable flowable composition comprising buprenorphine
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Patented Use: TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Methods to treat opioid use disorder
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Buprenorphine dosing regimens
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING OPIOID USE DISORDER


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Patented Use: TREATING OPIOID USE DISORDER

Injectable flowable composition comprising buprenorphine
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Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH

Injectable flowable composition comprising buprenorphine
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Patented Use: TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
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Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
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Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY

Injectable flowable composition buprenorphine
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Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition buprenorphine
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Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH

Injectable flowable composition buprenorphine
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Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION

Injectable flowable composition buprenorphine
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Patented Use: TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
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Patented Use: IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION

Injectable composition comprising buprenorphine
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Patented Use: TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE

Injectable composition comprising buprenorphine
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Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE

Injectable composition comprising buprenorphine
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Patented Use: TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE

Injectable composition comprising buprenorphine
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Patented Use: TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
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Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
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Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH

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

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/004743
Sixmo 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/004651
Treatment 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 11263478
Patent: Injectable flowable composition comprising buprenorphine
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012031290
Patent: composição fluidificável injetável compreendendo buprenorfina
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 01676
Patent: COMPOSITIONS (COMPOSITIONS)
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Chile

Patent: 12003462
Patent: 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.
Estimated Expiration: ⤷  Sign Up

China

Patent: 3079544
Patent: Injectable flowable composition comprising buprenorphine
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 70529
Patent: Sistema de suministro de buprenorfina de liberación sostenida
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0180118
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 20761
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 79874
Estimated Expiration: ⤷  Sign Up

Patent: 60538
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 79874
Patent: COMPOSITION FLUIDE INJECTABLE DE BUPRÉNORPHINE (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE)
Estimated Expiration: ⤷  Sign Up

Patent: 60538
Patent: COMPOSITION FLUIDE INJECTABLE DE BUPRÉNORPHINE (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE)
Estimated Expiration: ⤷  Sign Up

Patent: 18720
Patent: COMPOSITION FLUIDE INJECTABLE DE BUPRÉNORPHINE (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE)
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 60538
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 38275
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3488
Patent: תכשיר בר זרימה הניתן להזרקה המכיל בופרנורפיין (Injectable flowable composition comprising buprenorphine)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 86072
Estimated Expiration: ⤷  Sign Up

Patent: 51774
Estimated Expiration: ⤷  Sign Up

Patent: 13533230
Estimated Expiration: ⤷  Sign Up

Patent: 16155865
Patent: 組成物 (COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 79874
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 1625
Patent: INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 9209
Patent: COMPOSICIONES. (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE.)
Estimated Expiration: ⤷  Sign Up

Patent: 12014335
Patent: COMPOSICIONES. (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4026
Patent: Injectable flowable composition comprising buprenorphine
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Norway

Patent: 79874
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 79874
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 79874
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 07498
Patent: ЖИДКОТЕКУЧИЕ КОМПОЗИЦИИ ДЛЯ ИНЪЕКЦИЙ, ВКЛЮЧАЮЩИЕ БУПРЕНОРФИН (THIN-FLUID COMPOSITION FOR INJECTIONS CONTAINING BUPRENORPHINE)
Estimated Expiration: ⤷  Sign Up

Patent: 12157244
Patent: ЖИДКОТЕКУЧИЕ КОМПОЗИЦИИ ДЛЯ ИНЪЕКЦИЙ, ВКЛЮЧАЮЩИЕ БУПРЕНОРФИН
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Serbia

Patent: 820
Patent: INJEKTABILNA TEČNA KOMPOZICIJA KOJA SADRŽI BUPRENORFIN (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 6200
Patent: INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 79874
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1209233
Patent: INJECTABLE FLOWABLE COMPOSITION CIMPRISING BUPRENORPHINE
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South Korea

Patent: 1865689
Estimated Expiration: ⤷  Sign Up

Patent: 130135026
Patent: INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE
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Spain

Patent: 56938
Estimated Expiration: ⤷  Sign Up

Patent: 39612
Estimated Expiration: ⤷  Sign Up

United Kingdom

Patent: 81018
Patent: Buprenorphine sustained release system
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Patent: 13267
Patent: Injectable flowable composition comprising buprenorphine
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Patent: 1009549
Estimated Expiration: ⤷  Sign Up

Patent: 1413064
Estimated Expiration: ⤷  Sign Up

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
Denmark 2579874 ⤷  Sign Up
Canada 3015557 REGIMES POSOLOGIQUES DE BUPRENORPHINE (BUPRENORPHINE DOSING REGIMENS) ⤷  Sign Up
Singapore 11201703632W BUPRENORPHINE DOSING REGIMENS ⤷  Sign Up
Spain 2656938 ⤷  Sign Up
Poland 2579874 ⤷  Sign Up
European Patent Office 3215223 BUPRENORPHINE RÉGIME DOSAGE (BUPRENORPHINE DOSING REGIMENS) ⤷  Sign Up
Denmark 3360538 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.