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Last Updated: March 4, 2021

DrugPatentWatch Database Preview

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, 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, Mylan Technologies, 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-one NDAs. There are twenty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has forty-four patent family members in twenty-eight countries.

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

Drug Prices for buprenorphine

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Recent Clinical Trials for buprenorphine

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SponsorPhase
Centre Hospitalier Universitaire de NīmesPhase 3
VA Connecticut Healthcare SystemEarly Phase 1
The Wistar InstitutePhase 2

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Generic filers with tentative approvals for BUPRENORPHINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 8MG BASE;EQ 2MG BASEFILM;BUCCAL, SUBLINGUAL
  Start Trial  Start Trial8MGINJECTION, 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 204242-003 Dec 11, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Ethypharm BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 090622-002 Sep 24, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
>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 021306-002 Jun 30, 2010   Start Trial   Start Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010   Start Trial   Start Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010   Start Trial   Start Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-005 Jun 30, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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