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, Reacx Pharms, Indivior, Am Regent, Endo Operations, Hikma, Hospira, Actavis Elizabeth, Barr, Ethypharm, Norvium Bioscience, Rhodes Pharms, Rubicon, Sun Pharm, Difgen Pharms, 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-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for buprenorphine hydrochloride

International Patents:	92
US Patents:	20
Tradenames:	10
Applicants:	26
NDAs:	40
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	497
Patent Applications:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for buprenorphine hydrochloride
What excipients (inactive ingredients) are in buprenorphine hydrochloride?	buprenorphine hydrochloride excipients list
DailyMed Link:	buprenorphine hydrochloride at DailyMed

Recent Clinical Trials for buprenorphine hydrochloride

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 1
Icahn School of Medicine at Mount Sinai	Phase 4
Cure Addiction Now	Phase 3

See all buprenorphine hydrochloride clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
⤷ Sign Up	⤷ Sign Up	EQ 11.4MG BASE;EQ 2.9MG BASE	TABLET;SUBLINGUAL
⤷ Sign Up	⤷ Sign Up	EQ 8.6MG BASE;EQ 2.1MG BASE	TABLET;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 Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for buprenorphine hydrochloride

N02AE	Oripavine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

N07BC	Drugs used in opioid dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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

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Glossary

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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	204242-006	Oct 4, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Mylan Technologies	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	211785-002	Apr 17, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015	⤷ Sign Up	⤷ Sign Up
Reacx Pharms	PROBUPHINE	buprenorphine hydrochloride	IMPLANT;IMPLANTATION	204442-001	May 26, 2016	⤷ Sign Up	⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015	⤷ Sign Up	⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-005	Oct 23, 2015	⤷ Sign Up	⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for buprenorphine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
South Korea	20220047889	만성 통증 완화에 이용되는 점막 관통 약물 전달 장치 (TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF)	⤷ Sign Up
South Korea	20190110628	만성 통증 완화에 이용되는 점막 관통 약물 전달 장치 (TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF)	⤷ Sign Up
Hong Kong	1131344	TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE	⤷ Sign Up
Spain	2577390		⤷ Sign Up
South Korea	101329496		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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