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.
Summary for SUBLOCADE
International Patents: | 59 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 22 |
Clinical Trials: | 15 |
Patent Applications: | 4,004 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for SUBLOCADE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Royal Victoria Hospital, Canada | Phase 4 |
National Institute on Drug Abuse (NIDA) | Phase 4 |
Wake Forest University Health Sciences | Phase 2 |
Pharmacology for SUBLOCADE
Drug Class | Partial Opioid Agonist |
Mechanism of Action | Partial Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for SUBLOCADE
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
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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
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Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING OPIOID USE DISORDER
Injectable flowable composition comprising buprenorphine
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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
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Patent Expiration: ⤷ Try a Trial
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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Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
Injectable composition comprising buprenorphine
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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 |
---|---|---|---|
Serbia | 56820 | INJEKTABILNA TEČNA KOMPOZICIJA KOJA SADRŽI BUPRENORFIN (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE) | ⤷ Try a Trial |
Denmark | 3360538 | ⤷ Try a Trial | |
United Kingdom | 201413064 | ⤷ Try a Trial | |
United Kingdom | 2481018 | Buprenorphine sustained release system | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |