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Last Updated: July 23, 2021

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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 Amneal, Mylan Technologies, Watson Labs Teva, Purdue Pharma Lp, Indivior Inc, Bdsi, Titan Pharms, Am Regent, Hospira, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Ethypharm, Hikma, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Alvogen Pine Brook, Dr Reddys Labs Sa, Teva Pharms Usa, 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-two NDAs. There are thirty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has fifty-four patent family members in twenty-nine countries.

There are twenty-nine drug master file entries for buprenorphine. Three 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
Centre Hospitalier Universitaire de NÄ«mesPhase 3
University of California, DavisPhase 2
University of UtahPhase 2

See all buprenorphine clinical trials

Generic filers with tentative approvals for BUPRENORPHINE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it FreeEQ 8MG BASE;EQ 2MG BASEFILM;BUCCAL, SUBLINGUAL
⤷  Try it Free⤷  Try it Free8MGINJECTION, EXTENDED RELEASE;SUBCUTANEOUS

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 NDA Submissiondate
BUTRANS FILM, EXTENDED RELEASE;TRANSDERMAL buprenorphine 021306 2013-12-16
BUTRANS FILM, EXTENDED RELEASE;TRANSDERMAL buprenorphine 021306 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
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Mylan Technologies BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 211785-001 Apr 17, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Hikma BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 203326-001 Jun 27, 2014 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ⤷  Try it Free ⤷  Try it Free
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 ⤷  Try it Free ⤷  Try it Free
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-004 Jul 25, 2013 ⤷  Try it Free ⤷  Try it Free
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ⤷  Try it Free ⤷  Try it Free
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Harvard Business School
Baxter
McKesson
Boehringer Ingelheim

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.