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Last Updated: December 4, 2023

Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details

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

Buprenorphine hydrochloride; naloxone hydrochloride is the generic ingredient in five branded drugs marketed by Bdsi, Alvogen, Aveva, Dr Reddys Labs Sa, Mylan Technologies, Indivior, Teva Pharms Usa, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Wes Pharma Inc, and Orexo Us Inc, and is included in twenty-three NDAs. There are nineteen patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride; naloxone hydrochloride has three hundred and thirty-six patent family members in thirty-seven countries.

Twenty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for buprenorphine hydrochloride; naloxone hydrochloride

International Patents:	336
US Patents:	19
Tradenames:	5
Applicants:	18
NDAs:	23
Finished Product Suppliers / Packagers:	24
Clinical Trials:	130
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for buprenorphine hydrochloride; naloxone hydrochloride
DailyMed Link:	buprenorphine hydrochloride; naloxone hydrochloride at DailyMed

Recent Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride

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

Sponsor	Phase
Bicycle Health	Phase 4
Royal Victoria Hospital, Canada	Phase 4
Wake Forest University Health Sciences	Phase 2

See all buprenorphine hydrochloride; naloxone hydrochloride clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE; NALOXONE 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; naloxone hydrochloride

Drug Class	Opioid Antagonist Partial Opioid Agonist
Mechanism of Action	Opioid Antagonists Partial Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for buprenorphine hydrochloride; naloxone hydrochloride

Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	0.7 mg/0.18 mg	204242	1	2017-05-04
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	2.1 mg/0.3 mg and 4.2 mg/0.7 mg	205637	1	2016-11-23
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	2.9 mg/7.1 mg	204242	1	2015-12-21
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	6.3 mg/1 mg	205637	1	2015-12-21
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	8.6 mg/2.1 mg and 11.4 mg/2.9 mg	204242	1	2015-07-24
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	1.4 mg/0.36 mg and 5.7 mg/1.4 mg	204242	1	2013-10-22
SUBOXONE	Sublingual Film	buprenorphine hydrochloride; naloxone hydrochloride	12 mg/3 mg	022410	1	2013-05-14
SUBOXONE	Sublingual Film	buprenorphine hydrochloride; naloxone hydrochloride	2 mg/0.5 mg* and 8 mg/2 mg	022410	1	2012-10-15
SUBOXONE	for Injection	buprenorphine hydrochloride; naloxone hydrochloride	500 mg/vial	020733	2	2009-01-26

US Patents and Regulatory Information for buprenorphine hydrochloride; naloxone 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	204242-002	Jul 3, 2013		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Amneal Pharms	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	203136-002	Feb 22, 2013	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Technologies	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	207607-001	Jun 14, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	AB	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; naloxone hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	⤷ Try a Trial	⤷ Try a Trial
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	⤷ Try a Trial	⤷ Try a Trial
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013	⤷ Try a Trial	⤷ Try a Trial
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	⤷ Try a Trial	⤷ Try a Trial
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for buprenorphine hydrochloride; naloxone hydrochloride

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008100375		⤷ Try a Trial
Canada	2473970	COUCHES MINCES UNIFORMES SERVANT A DISSOUDRE RAPIDEMENT UNE FORME GALENIQUE INCORPORANT DES COMPOSITIONS DE MASQUAGE DE GOUT (UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING COMPOSITIONS)	⤷ Try a Trial
New Zealand	594545	TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE CONTAINING FENTANYL OR BUPRENORPHINE	⤷ Try a Trial
Slovenia	2915525		⤷ Try a Trial
Israel	217964	תכשירים בצורה שטוחה המכילים בופרנורפין ונלוקסון, פורמולציות בתצורה שטוחה המכילות אותם, ושימושן בהכנת תרופות לטיפול בתלות בחומרים נרקוטיים (Film dosage compositions comprising buprenorphine and naloxone, film formulations comprising the same and use thereof for the preparation of medicaments for treating narcotic dependence)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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