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Last Updated: October 12, 2024

SUBOXONE Drug Patent Profile


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When do Suboxone patents expire, and when can generic versions of Suboxone launch?

Suboxone is a drug marketed by Indivior and is included in two NDAs. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and ninety-three patent family members in twenty-six countries.

The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

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Drug patent expirations by year for SUBOXONE
Drug Prices for SUBOXONE

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Drug Sales Revenue Trends for SUBOXONE

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Recent Clinical Trials for SUBOXONE

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

SponsorPhase
Bicycle HealthPhase 4
Royal Victoria Hospital, CanadaPhase 4
Indivior Inc.Phase 1

See all SUBOXONE clinical trials

Pharmacology for SUBOXONE
Paragraph IV (Patent) Challenges for SUBOXONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUBOXONE Sublingual Film buprenorphine hydrochloride; naloxone hydrochloride 12 mg/3 mg 022410 1 2013-05-14
SUBOXONE Sublingual Film buprenorphine hydrochloride; naloxone hydrochloride 2 mg/0.5 mg* and 8 mg/2 mg 022410 1 2012-10-15
SUBOXONE for Injection buprenorphine hydrochloride; naloxone hydrochloride 500 mg/vial 020733 2 2009-01-26

US Patents and Regulatory Information for SUBOXONE

SUBOXONE is protected by four US patents.

Patents protecting SUBOXONE

Sublingual and buccal film compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING OPIOID USE DISORDER

Sublingual and buccal film compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE

Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION

Sublingual and buccal film compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 020733-002 Oct 8, 2002 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 AB 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

Expired US Patents for SUBOXONE

International Patents for SUBOXONE

When does loss-of-exclusivity occur for SUBOXONE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8417
Patent: COMPOSICIONES DE PELICULA SUBLINGUAL Y BUCAL
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 10279440
Patent: Sublingual and buccal film compositions
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012002817
Patent: composições sublinguais e bucais em filme
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 70180
Patent: COMPOSITIONS PELLICULAIRES SUBLINGUALES ET BUCCALES (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 12000313
Patent: Composición de dosificación de película que comprende una matriz portadora, entre 2-16 mg de buprenorfina, entre 0,5-5 mg de naloxona y un tampón que proporciona un ph local entre 2-4; procedimiento de preparación; uso en el tratamiento de la dependencia de narcóticos en un usuario.
Estimated Expiration: ⤷  Sign Up

China

Patent: 2548535
Patent: Sublingual and buccal film compositions
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 11219
Patent: COMPOSICIONES DE PELÍCULA SUBLINGUALES Y BUCALES
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0160368
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 61795
Estimated Expiration: ⤷  Sign Up

Patent: 31445
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 61795
Patent: COMPOSITIONS PELLICULAIRES SUBLINGUALES ET BUCCALES (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 31445
Patent: COMPOSITIONS PELLICULAIRES SUBLINGUALES ET BUCCALES (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 71960
Patent: 舌下和口腔用薄膜組合物 (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 7964
Patent: תכשירים בצורה שטוחה המכילים בופרנורפין ונלוקסון, פורמולציות בתצורה שטוחה המכילות אותם, ושימושן בהכנת תרופות לטיפול בתלות בחומרים נרקוטיים (Film dosage compositions comprising buprenorphine and naloxone, film formulations comprising the same and use thereof for the preparation of medicaments for treating narcotic dependence)
Estimated Expiration: ⤷  Sign Up

Patent: 4974
Patent: תכשירים בצורה שטוחה המכילים בופרנורפין ונלוקסון, פורמולציות בתצורה שטוחה המכילות אותם, ושימושן בהכנת תרופות לטיפול בתלות בחומרים נרקוטיים (Film dosage compositions comprising buprenorphine and naloxone, film formulations comprising the same and use thereof for the preparation of medicaments for treating narcotic dependence)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 19827
Estimated Expiration: ⤷  Sign Up

Patent: 13501717
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 6006
Patent: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 12001573
Patent: COMPOSICIONES DE PELÍCULA SUBLINGUALES Y BUCALES. (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8537
Patent: Sublingual and buccal film compositions
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 121136
Patent: COMPOSICIONES DE PELICULA SUBLINGUALES Y BUCALES
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 12108632
Patent: СУБЛИНГВАЛЬНЫЕ И БУККАЛЬНЫЕ ПЛЕНОЧНЫЕ КОМПОЗИЦИИ
Estimated Expiration: ⤷  Sign Up

Patent: 18121855
Patent: СУБЛИНГВАЛЬНЫЕ И БУККАЛЬНЫЕ ПЛЕНОЧНЫЕ КОМПОЗИЦИИ
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 8265
Patent: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Patent: 201601214V
Patent: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1201647
Patent: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1699321
Estimated Expiration: ⤷  Sign Up

Patent: 120059538
Patent: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 62634
Estimated Expiration: ⤷  Sign Up

Patent: 57814
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 SUBOXONE around the world.

Country Patent Number Title Estimated Expiration
Australia 2010214780 Polyethylene oxide-based films and drug delivery systems made therefrom ⤷  Sign Up
China 102481250 Sublingual And Buccal Film Compositions ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2014144241 ⤷  Sign Up
Austria 536869 ⤷  Sign Up
Australia 2006322050 Topical film compositions for delivery of actives ⤷  Sign Up
World Intellectual Property Organization (WIPO) 02103441 ⤷  Sign Up
Australia 2010279441 Sublingual and buccal film compositions ⤷  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.