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Last Updated: July 19, 2024

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 fourteen branded drugs marketed by Alvogen, Amneal, Aveva, Mylan Tech Viatris, Watson Labs Teva, Purdue Pharma Lp, Braeburn, Indivior, Bdsi, Reacx Pharms, Am Regent, Endo Operations, Hikma, Hospira, 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, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in forty-eight NDAs. There are thirty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has one hundred and seventy-four patent family members in thirty-five countries.

There are twenty-nine drug master file entries for buprenorphine. Nine suppliers are listed for this compound. There are two 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
Brigham and Women's HospitalPhase 1
Icahn School of Medicine at Mount SinaiPhase 4
Cure Addiction NowPhase 3

See all BUPRENORPHINE clinical trials

Generic filers with tentative approvals for BUPRENORPHINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 8MG BASE;EQ 2MG BASEFILM;BUCCAL, SUBLINGUAL
⤷  Sign Up⤷  Sign UpEQ 0.7MG BASE;EQ 0.18MG BASETABLET;SUBLINGUAL
⤷  Sign Up⤷  Sign UpEQ 2.9MG BASE;EQ 0.71MG 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
Drug ClassPartial Opioid Agonist
Mechanism of ActionPartial Opioid Agonists
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
Hikma BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride INJECTABLE;INJECTION 076931-001 Mar 2, 2005 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alvogen BUPRENORPHINE buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 207490-003 May 17, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Braeburn BRIXADI buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 210136-003 May 23, 2023 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Indivior SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  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 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 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-004 Jul 25, 2013 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ⤷  Sign Up ⤷  Sign Up
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 ⤷  Sign Up ⤷  Sign Up
>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
Canada 2801676 COMPOSITIONS (COMPOSITIONS) ⤷  Sign Up
Poland 2206495 ⤷  Sign Up
Peru 20150672 FORMULACIONES DE OPIOIDES ⤷  Sign Up
Slovenia 2579874 ⤷  Sign Up
Canada 3015557 REGIMES POSOLOGIQUES DE BUPRENORPHINE (BUPRENORPHINE DOSING REGIMENS) ⤷  Sign Up
United Kingdom 201413064 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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