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Last Updated: March 19, 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-five suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

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

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

Sublingual and buccal film compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 020733-002 Oct 8, 2002 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

Expired US Patents for SUBOXONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 ⤷  Try a Trial ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 ⤷  Try a Trial ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 ⤷  Try a Trial ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 ⤷  Try a Trial ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 10279440
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2012002817
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 70180
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 12000313
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2548535
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 11219
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0160368
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 61795
Estimated Expiration: ⤷  Try a Trial

Patent: 31445
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 61795
Estimated Expiration: ⤷  Try a Trial

Patent: 31445
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 71960
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 7964
Estimated Expiration: ⤷  Try a Trial

Patent: 4974
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 19827
Estimated Expiration: ⤷  Try a Trial

Patent: 13501717
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 6006
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 12001573
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8537
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 121136
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 12108632
Estimated Expiration: ⤷  Try a Trial

Patent: 18121855
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 8265
Estimated Expiration: ⤷  Try a Trial

Patent: 201601214V
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1201647
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1699321
Estimated Expiration: ⤷  Try a Trial

Patent: 120059538
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 62634
Estimated Expiration: ⤷  Try a Trial

Patent: 57814
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 SUBOXONE around the world.

Country Patent Number Title Estimated Expiration
China 102481250 Sublingual And Buccal Film Compositions ⤷  Try a Trial
Chile 2012000313 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. ⤷  Try a Trial
European Patent Office 1971312 COMPOSITIONS DE FILMS TOPIQUES POUR LA LIBERATION D ACTIFS (TOPICAL FILM COMPOSITIONS FOR DELIVERY OF ACTIVES) ⤷  Try a Trial
Spain 2562634 ⤷  Try a Trial
Canada 2514897 FILM MINCE A HETEROGENEITE UNIFORME NON AUTO-AGGLOMERANTE ETSYSTEMES D'ADMINISTRATION DE MEDICAMENTS A BASE DUDIT FILM (THIN FILM WITH NON-SELF-AGGREGATING UNIFORM HETEROGENEITY AND DRUG DELIVERY SYSTEMS MADE THEREFROM) ⤷  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.