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Last Updated: June 28, 2022

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 Inc and is included in one NDA. There are eleven patents protecting this drug.

This drug has fifty-six patent family members in thirty countries.

The generic ingredient in SUBLOCADE is buprenorphine. There are twenty-nine drug master file entries for this compound. Six 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

See drug prices for SUBLOCADE

Recent Clinical Trials for SUBLOCADE

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

SponsorPhase
Wake Forest University Health SciencesPhase 2
Johns Hopkins UniversityPhase 2
M. Eugenia SociasPhase 4

See all SUBLOCADE clinical trials

Pharmacology for SUBLOCADE

US Patents and Regulatory Information for SUBLOCADE

SUBLOCADE is protected by twenty-three US patents.

Patents protecting SUBLOCADE

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Methods to treat opioid use disorder
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Buprenorphine dosing regimens
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID USE DISORDER

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY

Injectable flowable composition buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH

Injectable flowable composition buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION

Injectable flowable composition buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION

Injectable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE

Injectable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE

Injectable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE

Injectable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE

Injectable flowable composition comprising buprenorphine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 Inc SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Indivior Inc SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Indivior Inc SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Indivior Inc SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Indivior Inc SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-001 Nov 30, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Indivior Inc SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-001 Nov 30, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2012031290
Estimated Expiration: See Plans and Pricing

Canada

Patent: 01676
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12003462
Estimated Expiration: See Plans and Pricing

China

Patent: 3079544
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 70529
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0180118
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20761
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 79874
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 79874
Estimated Expiration: See Plans and Pricing

Patent: 60538
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 38275
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3488
Estimated Expiration: See Plans and Pricing

Patent: 4417
Estimated Expiration: See Plans and Pricing

Japan

Patent: 86072
Estimated Expiration: See Plans and Pricing

Patent: 51774
Estimated Expiration: See Plans and Pricing

Patent: 13533230
Estimated Expiration: See Plans and Pricing

Patent: 16155865
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 79874
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 1625
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9209
Estimated Expiration: See Plans and Pricing

Patent: 12014335
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4026
Estimated Expiration: See Plans and Pricing

Norway

Patent: 79874
Estimated Expiration: See Plans and Pricing

Poland

Patent: 79874
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 79874
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 07498
Estimated Expiration: See Plans and Pricing

Patent: 12157244
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 820
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 6200
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 79874
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1209233
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1865689
Estimated Expiration: See Plans and Pricing

Patent: 130135026
Estimated Expiration: See Plans and Pricing

Spain

Patent: 56938
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 81018
Estimated Expiration: See Plans and Pricing

Patent: 13267
Estimated Expiration: See Plans and Pricing

Patent: 1009549
Estimated Expiration: See Plans and Pricing

Patent: 1413064
Estimated Expiration: See Plans and Pricing

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
Malaysia 171625 INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE See Plans and Pricing
Hungary E038275 See Plans and Pricing
Slovenia 2579874 See Plans and Pricing
Israel 254417 See Plans and Pricing
Portugal 2579874 See Plans and Pricing
Canada 2965895 REGIMES POSOLOGIQUES DE BUPRENORPHINE (BUPRENORPHINE DOSING REGIMENS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Dow
Mallinckrodt
Moodys
McKinsey

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.