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Last Updated: February 28, 2024

SUBLOCADE Drug Patent Profile


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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 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

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

Buprenorphine dosing regimens
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID USE DISORDER


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID USE DISORDER

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY

Injectable flowable composition buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH

Injectable flowable composition buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION

Injectable flowable composition buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION

Injectable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE

Injectable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE

Injectable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE

Injectable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE

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

Injectable flowable composition comprising buprenorphine
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Indivior SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Indivior SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Indivior SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2012031290
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 01676
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 12003462
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3079544
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 70529
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0180118
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20761
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 79874
Estimated Expiration: ⤷  Try a Trial

Patent: 60538
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 79874
Estimated Expiration: ⤷  Try a Trial

Patent: 60538
Estimated Expiration: ⤷  Try a Trial

Patent: 18720
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 60538
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 38275
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3488
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 86072
Estimated Expiration: ⤷  Try a Trial

Patent: 51774
Estimated Expiration: ⤷  Try a Trial

Patent: 13533230
Estimated Expiration: ⤷  Try a Trial

Patent: 16155865
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 79874
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 1625
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 9209
Estimated Expiration: ⤷  Try a Trial

Patent: 12014335
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4026
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 79874
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 79874
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 79874
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 07498
Estimated Expiration: ⤷  Try a Trial

Patent: 12157244
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 820
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 6200
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 79874
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1209233
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1865689
Estimated Expiration: ⤷  Try a Trial

Patent: 130135026
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 56938
Estimated Expiration: ⤷  Try a Trial

Patent: 39612
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 81018
Estimated Expiration: ⤷  Try a Trial

Patent: 13267
Estimated Expiration: ⤷  Try a Trial

Patent: 1009549
Estimated Expiration: ⤷  Try a Trial

Patent: 1413064
Estimated Expiration: ⤷  Try a Trial

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
Singapore 186200 INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE ⤷  Try a Trial
European Patent Office 2579874 COMPOSITION FLUIDE INJECTABLE DE BUPRÉNORPHINE (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE) ⤷  Try a Trial
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. ⤷  Try a Trial
Canada 3015557 REGIMES POSOLOGIQUES DE BUPRENORPHINE (BUPRENORPHINE DOSING REGIMENS) ⤷  Try a Trial
>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.