Last Updated: September 28, 2026

SUBUTEX Drug Patent Profile

Name: SUBUTEX Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Subutex, and what generic alternatives are available?

Subutex is a drug marketed by Indivior and is included in one NDA.

The generic ingredient in SUBUTEX is buprenorphine hydrochloride. There is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Subutex

A generic version of SUBUTEX was approved as buprenorphine hydrochloride by HOSPIRA on June 3^rd, 1996.

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Summary for SUBUTEX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	40
Patent Applications:	21
DailyMed Link:	SUBUTEX at DailyMed

Drug patent expirations by year for SUBUTEX

Recent Clinical Trials for SUBUTEX

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Sponsor	Phase
Erin Winstanley	PHASE4
National Institute on Drug Abuse (NIDA)	PHASE4
Theresa Winhusen, PhD	Phase 3

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US Patents and Regulatory Information for SUBUTEX

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indivior	SUBUTEX	buprenorphine hydrochloride	TABLET;SUBLINGUAL	020732-002	Oct 8, 2002		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Indivior	SUBUTEX	buprenorphine hydrochloride	TABLET;SUBLINGUAL	020732-003	Oct 8, 2002		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.