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Last Updated: August 11, 2022

Buprenorphine - Generic Drug Details


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What are the generic sources for buprenorphine and what is the scope of freedom to operate?

Buprenorphine is the generic ingredient in thirteen branded drugs marketed by Alvogen, Amneal, Aveva, Mylan Tech Viatris, Watson Labs Teva, Purdue Pharma Lp, Indivior Inc, Bdsi, Titan Pharms, Am Regent, Hikma, Hospira, Par Sterile Products, Actavis Elizabeth, Barr, Ethypharm, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Mayne Pharma Inc, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in forty-seven NDAs. There are thirty-four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has fifty-six patent family members in thirty countries.

There are twenty-nine drug master file entries for buprenorphine. Six suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for buprenorphine

See drug prices for buprenorphine

Recent Clinical Trials for buprenorphine

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

SponsorPhase
Carolinas Pain InstitutePhase 4
BioDelivery Sciences InternationalPhase 4
University of Texas Southwestern Medical CenterPhase 2

See all buprenorphine clinical trials

Generic filers with tentative approvals for BUPRENORPHINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 8MG BASE;EQ 2MG BASEFILM;BUCCAL, SUBLINGUAL
See Plans and PricingSee Plans and Pricing8MGINJECTION, EXTENDED RELEASE;SUBCUTANEOUS
See Plans and PricingSee Plans and PricingEQ 0.7MG BASE;EQ 0.18MG BASETABLET;SUBLINGUAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for buprenorphine
Medical Subject Heading (MeSH) Categories for buprenorphine
Paragraph IV (Patent) Challenges for BUPRENORPHINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BUTRANS Transdermal System buprenorphine 15 mcg/hr 021306 1 2013-12-16
BUTRANS Transdermal System buprenorphine 5 mcg/hr 10 mcg/hr 20 mcg/hr 021306 1 2013-06-06

US Patents and Regulatory Information for buprenorphine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal BUPRENORPHINE buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 211586-001 Apr 14, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 203136-002 Feb 22, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Indivior Inc SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y 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 buprenorphine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-005 Jun 30, 2014 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-005 Jun 30, 2014 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for buprenorphine

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 buprenorphine

Country Patent Number Title Estimated Expiration
Japan 5986072 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2016071767 See Plans and Pricing
China 103079544 Injectable flowable composition comprising buprenorphine See Plans and Pricing
Canada 3015557 REGIMES POSOLOGIQUES DE BUPRENORPHINE (BUPRENORPHINE DOSING REGIMENS) See Plans and Pricing
European Patent Office 3638240 PROCÉDÉS DE TRAITEMENT D'UN TROUBLE LIÉ À L'USAGE D'OPIOÏDES (METHODS TO TREAT OPIOID USE DISORDER) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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