Buprenorphine - Generic Drug Details

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

Buprenorphine is the generic ingredient in thirteen branded drugs marketed by Alvogen, Amneal, Aveva, Mylan Tech Viatris, Watson Labs Teva, Purdue Pharma Lp, Indivior Inc, Bdsi, Titan Pharms, Am Regent, Hikma, Hospira, Par Sterile Products, Actavis Elizabeth, Barr, Ethypharm, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Mayne Pharma Inc, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in forty-seven NDAs. There are thirty-five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has fifty-six patent family members in thirty countries.

There are twenty-nine drug master file entries for buprenorphine. Seven suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for buprenorphine

International Patents:	56
US Patents:	35
Tradenames:	13
Applicants:	31
NDAs:	47
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	478
Patent Applications:	4,995
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends 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

See drug prices for buprenorphine

Recent Clinical Trials for buprenorphine

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

Sponsor	Phase
Elina Brinck	Phase 1
Carolinas Pain Institute	Phase 4
BioDelivery Sciences International	Phase 4

See all buprenorphine clinical trials

Generic filers with tentative approvals for BUPRENORPHINE

Applicant	Application No.	Strength	Dosage Form
		EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
		8MG	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS
		EQ 0.7MG BASE;EQ 0.18MG 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

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for buprenorphine

Analgesics, Opioid

Narcotic Antagonists

Narcotics

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rhodes Pharms	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	TABLET;SUBLINGUAL	207276-001	Mar 27, 2017	AB	RX	No	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016		RX	Yes	No			Y
Par Sterile Products	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	INJECTABLE;INJECTION	206586-001	Jul 28, 2015	AP	RX	No	No
Alvogen	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	205954-001	Jan 24, 2019	AB	RX	No	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes			Y
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	020733-001	Oct 8, 2002		DISCN	Yes	No

Expired US Patents for buprenorphine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-004	Jul 25, 2013
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-004	Jul 25, 2013

EU/EMA Drug Approvals for buprenorphine

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

International Patents for buprenorphine

Country	Patent Number	Title	Estimated Expiration
United Kingdom	201009549
Serbia	56820	INJEKTABILNA TEČNA KOMPOZICIJA KOJA SADRŽI BUPRENORFIN (INJECTABLE FLOWABLE COMPOSITION COMPRISING BUPRENORPHINE)
Israel	251870
World Intellectual Property Organization (WIPO)	2018229551
Australia	2011263478	Injectable flowable composition comprising buprenorphine
Japan	6251774
Japan	2013533230