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Last Updated: April 28, 2024

BUPRENORPHINE Drug Patent Profile

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Which patents cover Buprenorphine, and what generic alternatives are available?

Buprenorphine is a drug marketed by Alvogen, Amneal, Aveva, Mylan Tech Viatris, Watson Labs Teva, Am Regent, Hikma, Hospira, Par Sterile Products, Actavis Elizabeth, Barr, Ethypharm, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, 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-six NDAs.

The generic ingredient in BUPRENORPHINE 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

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

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Summary for BUPRENORPHINE

US Patents:	0
Applicants:	25
NDAs:	36
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	490
Patent Applications:	4,004
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BUPRENORPHINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUPRENORPHINE
What excipients (inactive ingredients) are in BUPRENORPHINE?	BUPRENORPHINE excipients list
DailyMed Link:	BUPRENORPHINE at DailyMed

Drug patent expirations by year for BUPRENORPHINE

Drug Prices for BUPRENORPHINE

Recent Clinical Trials for BUPRENORPHINE

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Sponsor	Phase
Gangnam Severance Hospital	N/A
Washington University School of Medicine	Phase 3
Loyola University	Phase 4

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Pharmacology for BUPRENORPHINE

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for BUPRENORPHINE

Analgesics, Opioid
Narcotic Antagonists
Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for BUPRENORPHINE

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BUTRANS	Transdermal System	buprenorphine	15 mcg/hr	021306	1	2013-12-16
BUTRANS	Transdermal System	buprenorphine	5 mcg/hr 10 mcg/hr 20 mcg/hr	021306	1	2013-06-06

US Patents and Regulatory Information for BUPRENORPHINE

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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
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
Ethypharm	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	TABLET;SUBLINGUAL	090622-001	Sep 24, 2010	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alvogen	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	FILM;BUCCAL	211594-007	Aug 3, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	201633-002	Aug 5, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rubicon	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	TABLET;SUBLINGUAL	090279-001	Jun 10, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

EU/EMA Drug Approvals for BUPRENORPHINE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.	Sixmo	buprenorphine	EMEA/H/C/004743 Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.	Authorised	no	no	no	2019-06-19
Camurus AB	Buvidal	buprenorphine	EMEA/H/C/004651 Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.	Authorised	no	no	no	2018-11-20
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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