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Last Updated: November 29, 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-five 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. Seven 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
Elina BrinckPhase 1
Carolinas Pain InstitutePhase 4
BioDelivery Sciences InternationalPhase 4

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
Rhodes Pharms BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 207276-001 Mar 27, 2017 AB RX No No See Plans and Pricing See Plans and Pricing 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
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Par Sterile Products BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride INJECTABLE;INJECTION 206586-001 Jul 28, 2015 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alvogen BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 205954-001 Jan 24, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 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 buprenorphine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021306-003 Jun 30, 2010 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 021306-001 Jun 30, 2010 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-004 Jul 25, 2013 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 021306-004 Jul 25, 2013 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
United Kingdom 201009549 See Plans and Pricing
Serbia 56820 INJEKTABILNA TEČNA KOMPOZICIJA KOJA SADRŽI BUPRENORFIN (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE) See Plans and Pricing
Israel 251870 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2018229551 See Plans and Pricing
Australia 2011263478 Injectable flowable composition comprising buprenorphine See Plans and Pricing
Japan 6251774 See Plans and Pricing
Japan 2013533230 See Plans and Pricing
>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.