BUPRENORPHINE HYDROCHLORIDE Drug Patent Profile

When do Buprenorphine Hydrochloride patents expire, and what generic alternatives are available?

Buprenorphine Hydrochloride is a drug marketed by Alvogen, Am Regent, Endo Operations, Hikma, Hospira, Actavis Elizabeth, Barr, Ethypharm, Norvium Bioscience, Rhodes Pharms, Rubicon, Sun Pharm, Aveva, Dr Reddys Labs Sa, Mylan Technologies, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Teva Pharms Usa, and Wes Pharma Inc. and is included in thirty-one NDAs.

The generic ingredient in BUPRENORPHINE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four 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

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

Summary for BUPRENORPHINE HYDROCHLORIDE

US Patents:	0
Applicants:	22
NDAs:	31
Finished Product Suppliers / Packagers:	20
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
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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Technologies	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	207607-002	Jun 14, 2018	AB	RX	No	No
Aveva	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	212756-001	Jun 2, 2022	AB	RX	No	No
Dr Reddys Labs Sa	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	206953-002	Jul 17, 2020		DISCN	No	No
Sun Pharm	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	201633-001	Aug 5, 2016	AB	RX	No	No
Alkem Labs Ltd	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	214930-002	Jun 15, 2021	AB	RX	No	No
Ethypharm Usa Corp	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204431-001	Oct 16, 2015	AB	RX	No	No