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Last Updated: December 5, 2020

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BUPRENORPHINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for buprenorphine hydrochloride and what is the scope of patent protection?

Buprenorphine hydrochloride is the generic ingredient in ten branded drugs marketed by Bdsi, Titan Pharms, Indivior Inc, 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 thirty-seven NDAs. There are nineteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride has one hundred and fourteen patent family members in thirty countries.

There are twenty-nine drug master file entries for buprenorphine hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for BUPRENORPHINE HYDROCHLORIDE

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

SponsorPhase
Centre Hospitalier Universitaire de NīmesPhase 3
VA Connecticut Healthcare SystemEarly Phase 1
National Institute of Drug AbusePhase 2

See all BUPRENORPHINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 8MG BASE;EQ 2MG BASEFILM;BUCCAL, 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 HYDROCHLORIDE
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
BELBUCA FILM;BUCCAL buprenorphine hydrochloride 207932 2016-10-24
BELBUCA FILM;BUCCAL buprenorphine hydrochloride 207932 2016-10-04
BELBUCA FILM;BUCCAL buprenorphine hydrochloride 207932 2016-09-12

US Patents and Regulatory Information for BUPRENORPHINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 RX Yes 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
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
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-002 Aug 30, 2010 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-001 Jul 3, 2013 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 HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Express Scripts

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