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Last Updated: March 28, 2024

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, Alvogen, Titan Pharms, Indivior, 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, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in forty NDAs. There are twenty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are sixteen drug master file entries for buprenorphine hydrochloride. Twenty 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
Gangnam Severance HospitalN/A
Washington University School of MedicinePhase 3
Loyola UniversityPhase 4

See all BUPRENORPHINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 8MG BASE;EQ 2MG BASEFILM;BUCCAL, SUBLINGUAL
⤷  Try a Trial⤷  Try a TrialEQ 11.4MG BASE;EQ 2.9MG BASETABLET;SUBLINGUAL
⤷  Try a Trial⤷  Try a TrialEQ 8.6MG BASE;EQ 2.1MG 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
Drug ClassPartial Opioid Agonist
Mechanism of ActionPartial Opioid Agonists
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
Teva Pharms Usa CASSIPA buprenorphine hydrochloride; naloxone hydrochloride FILM;SUBLINGUAL 208042-001 Sep 7, 2018 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Indivior BUPRENEX buprenorphine hydrochloride INJECTABLE;INJECTION 018401-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Alvogen BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride FILM;BUCCAL 211594-005 Aug 3, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 207932-001 Oct 23, 2015 ⤷  Try a Trial ⤷  Try a Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 ⤷  Try a Trial ⤷  Try a Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 ⤷  Try a Trial ⤷  Try a Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BUPRENORPHINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Brazil PI0714712 dispositivos de distribuiÇço transmucosal com absorÇço intensificada ⤷  Try a Trial
Japan 5689144 ⤷  Try a Trial
Slovenia 2561860 ⤷  Try a Trial
Russian Federation 2504377 СПОСОБ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА, СРЕДСТВО ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ БОЛИ (METHOD FOR TRANSMUCOSAL DRUG DELIVERY, AGENT FOR TRANSMUCOSAL DRUG DELIVERY (VERSIONS) AND METHOD FOR PAIN MANAGEMENT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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