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Last Updated: December 7, 2022

Buprenorphine hydrochloride - Generic Drug Details


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What are the generic drug sources for buprenorphine hydrochloride and what is the scope of freedom to operate?

Buprenorphine hydrochloride is the generic ingredient in ten branded drugs marketed by Bdsi, Alvogen, Titan Pharms, Indivior Inc, Am Regent, Hikma, Hospira, Par Sterile Products, Actavis Elizabeth, Barr, Ethypharm, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Aveva, 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 NDAs. There are twenty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride has ninety-one patent family members in twenty-eight countries.

There are sixteen drug master file entries for buprenorphine hydrochloride. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for buprenorphine hydrochloride

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

SponsorPhase
Elina BrinckPhase 1
Icahn School of Medicine at Mount SinaiPhase 3
Royal Victoria Hospital, CanadaPhase 4

See all buprenorphine hydrochloride clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE
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 PricingEQ 0.7MG BASE;EQ 0.18MG BASETABLET;SUBLINGUAL
See Plans and PricingSee Plans and PricingEQ 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 hydrochloride
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BELBUCA Buccal Film buprenorphine hydrochloride 75 mcg and 150 mcg 207932 1 2016-10-24
BELBUCA Buccal Film buprenorphine hydrochloride 300 mcg, 450 mcg, 600 mcg and 750 mcg 207932 1 2016-10-04
BELBUCA Buccal Film buprenorphine hydrochloride 900 mcg 207932 1 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
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-003 Aug 10, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mylan Technologies BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 207607-002 Jun 14, 2018 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 204242-006 Oct 4, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Indivior Inc SUBUTEX buprenorphine hydrochloride TABLET;SUBLINGUAL 020732-003 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 hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 See Plans and Pricing See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 See Plans and Pricing See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 See Plans and Pricing See Plans and Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.