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Last Updated: April 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.

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:	20
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	490
Patent Applications:	2
Formulation / Manufacturing:	see details
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
Gangnam Severance Hospital	N/A
Washington University School of Medicine	Phase 3
Loyola University	Phase 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 Trial	EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
⤷ Try a Trial	⤷ Try a Trial	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET;SUBLINGUAL
⤷ Try a Trial	⤷ Try a Trial	EQ 2.9MG BASE;EQ 0.71MG 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
Teva Pharms Usa	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	091149-002	Sep 8, 2014		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Lannett Co Inc	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	205022-001	Sep 19, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015	⤷ Try a Trial	⤷ Try a Trial
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-007	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	207932-005	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
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-005	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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2561860	Dispositif polymère implantable pour libération prolongée de buprénorphine (Implantable polymeric device for sustained release of buprenorphine)	⤷ Try a Trial
Australia	2019202602	Transmucosal drug delivery devices for use in chronic pain relief	⤷ Try a Trial
Norway	20090278		⤷ Try a Trial
China	104125828	Transmucosal drug delivery devices for use in chronic pain relief	⤷ Try a Trial
South Korea	20140106720	TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF	⤷ Try a Trial
South Africa	201804381	TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF	⤷ Try a Trial
Japan	2015500886	慢性疼痛軽減に用いるための経粘膜薬物送達デバイス	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated 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.