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Last Updated: March 19, 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 0.7MG BASE;EQ 0.18MG BASETABLET;SUBLINGUAL
⤷  Try a Trial⤷  Try a TrialEQ 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
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
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Indivior SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 201633-001 Aug 5, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 214930-001 Jun 15, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 207932-002 Oct 23, 2015 ⤷  Try a Trial ⤷  Try a Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 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
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015 ⤷  Try a Trial ⤷  Try a Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 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
Norway 344719 ⤷  Try a Trial
Singapore 11201403075X TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF ⤷  Try a Trial
Singapore 10202012743W TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF ⤷  Try a Trial
Israel 220722 שימוש בפנטניל להכנת תכשיר רוקחי להקלה מהירה לכאב מתפרץ והתקן מתכלה ביולוגית למתן דרך הרירית המתאים למתן ישיר דרך הרירית של פנטיל (Use of fentanyl in the preparation of a pharmaceutical composition for providing rapid onset of relief from breakthrough pain and a mucoadhesive bioerodable drug delivery device suitable for direct transmucosal administration of fentanyl) ⤷  Try a Trial
European Patent Office 1509182 DISPOSITIF POLYMERE IMPLANTABLE PERMETTANT LA LIBERATION PROLONGEE DE BUPRENORPHINE (IMPLANTABLE POLYMERIC DEVICE FOR SUSTAINED RELEASE OF BUPRENORPHINE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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