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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE Drug Profile

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When do Buprenorphine Hydrochloride And Naloxone Hydrochloride patents expire, and when can generic versions of Buprenorphine Hydrochloride And Naloxone Hydrochloride launch?

Buprenorphine Hydrochloride And Naloxone Hydrochloride is a drug marketed by Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Mayne Pharma Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Teva Pharms Usa, and Wes Pharma Inc. and is included in sixteen NDAs.

The generic ingredient in BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Buprenorphine Hydrochloride And Naloxone Hydrochloride

A generic version of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22^nd, 2013.

Summary for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

US Patents:	0
Applicants:	14
NDAs:	16
Suppliers / Packagers:	19
Bulk Api Vendors:	1
Clinical Trials:	112
Formulation / Manufacturing:	see details
DailyMed Link:	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

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

Sponsor	Phase
The Wistar Institute	Phase 2
IMEA Paris	Phase 2
National Institute of Drug Abuse	Phase 2

See all BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE clinical trials

Pharmacology for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

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

US Patents and Regulatory Information for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE 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	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	091149-002	Sep 8, 2014		DISCN	No	No
Specgx Llc	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	207000-002	Dec 13, 2017	AB	RX	No	No
Wes Pharma Inc	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	209069-001	Jul 17, 2020	AB	RX	No	No
Sun Pharm	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	201633-001	Aug 5, 2016	AB	RX	No	No
Alvogen Pine Brook	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	205954-001	Jan 24, 2019	AB	RX	No	No
Ethypharm Usa Corp	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204431-002	Oct 16, 2015	AB	RX	No	No
Mayne Pharma Inc	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	206953-002	Jul 17, 2020	AB	RX	No	No