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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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: | 3,976 |
| 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 |
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
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Patented Use: TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
Buprenorphine dosing regimens
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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
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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
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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 | |||
| >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
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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
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1865689
Estimated Expiration: ⤷ Sign Up
Patent: 130135026
Patent: INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 56938
Estimated Expiration: ⤷ Sign Up
Patent: 39612
Estimated Expiration: ⤷ Sign Up
United Kingdom
Patent: 81018
Patent: Buprenorphine sustained release system
Estimated Expiration: ⤷ Sign Up
Patent: 13267
Patent: Injectable flowable composition comprising buprenorphine
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Spain | 2656938 | ⤷ Sign Up | |
| United Kingdom | 201413064 | ⤷ Sign Up | |
| European Patent Office | 4218720 | COMPOSITION FLUIDE INJECTABLE DE BUPRÉNORPHINE (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE) | ⤷ Sign Up |
| New Zealand | 604026 | Injectable flowable composition comprising buprenorphine | ⤷ Sign Up |
| European Patent Office | 3638240 | PROCÉDÉS DE TRAITEMENT D'UN TROUBLE LIÉ À L'USAGE D'OPIOÏDES (METHODS TO TREAT OPIOID USE DISORDER) | ⤷ Sign Up |
| United Kingdom | 2513267 | Injectable flowable composition comprising buprenorphine | ⤷ 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.
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