Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Baxter
Merck
McKesson
Moodys

Last Updated: May 20, 2022

SUBOXONE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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

Suboxone is a drug marketed by Indivior Inc and is included in two NDAs. There are eight 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-two 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 eight US patents.

Patents protecting SUBOXONE

Sublingual and buccal film compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sublingual and buccal film compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING OPIOID USE DISORDER

Polyethylene oxide-based films and drug delivery systems made therefrom
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sublingual and buccal film compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION

Sublingual and buccal film compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION

Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Patent Number: See Plans and Pricing
Patent Expiration: 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
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 020733-001 Oct 8, 2002 DISCN Yes No See Plans and Pricing See Plans and Pricing 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

Expired US Patents for SUBOXONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 See Plans and Pricing See Plans and Pricing
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 See Plans and Pricing See Plans and Pricing
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 10279440
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012002817
Estimated Expiration: See Plans and Pricing

Canada

Patent: 70180
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12000313
Estimated Expiration: See Plans and Pricing

China

Patent: 2548535
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 11219
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160368
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 61795
Estimated Expiration: See Plans and Pricing

Patent: 31445
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 61795
Estimated Expiration: See Plans and Pricing

Patent: 31445
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 71960
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7964
Estimated Expiration: See Plans and Pricing

Patent: 4974
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19827
Estimated Expiration: See Plans and Pricing

Patent: 13501717
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 6006
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12001573
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8537
Estimated Expiration: See Plans and Pricing

Peru

Patent: 121136
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 12108632
Estimated Expiration: See Plans and Pricing

Patent: 18121855
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 8265
Estimated Expiration: See Plans and Pricing

Patent: 201601214V
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1201647
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1699321
Estimated Expiration: See Plans and Pricing

Patent: 120059538
Estimated Expiration: See Plans and Pricing

Spain

Patent: 62634
Estimated Expiration: See Plans and Pricing

Patent: 57814
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 SUBOXONE around the world.

Country Patent Number Title Estimated Expiration
Australia 2002362772 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008100375 See Plans and Pricing
Canada 2468557 EMBALLAGE DESTINE DES COMPOSANTS ELECTRO-OPTIQUES (PACKAGE FOR ELECTRO-OPTICAL COMPONENTS) 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:

Moodys
Medtronic
Colorcon
Harvard Business School
AstraZeneca
Dow

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.