Buprenorphine hydrochloride - Generic Drug Details

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

Buprenorphine hydrochloride is the generic ingredient in ten branded drugs marketed by Bdsi, Titan Pharms, Indivior Inc, Am Regent, Hospira, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Ethypharm, Hikma, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Mayne Pharma Inc, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in thirty-seven NDAs. There are nineteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride has one hundred and fifteen patent family members in thirty countries.

There are twenty-nine drug master file entries for buprenorphine hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for buprenorphine hydrochloride

International Patents:	115
US Patents:	19
Tradenames:	10
Applicants:	26
NDAs:	37
Drug Master File Entries:	29
Suppliers / Packagers:	18
Bulk Api Vendors:	20
Clinical Trials:	434
Patent Applications:	2
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for buprenorphine hydrochloride
What excipients (inactive ingredients) are in buprenorphine hydrochloride?	buprenorphine hydrochloride excipients list
DailyMed Link:	buprenorphine hydrochloride at DailyMed

Recent Clinical Trials for buprenorphine hydrochloride

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

Sponsor	Phase
Centre Hospitalier Universitaire de Nīmes	Phase 3
University of Utah	Phase 2
University of California, Davis	Phase 2

See all buprenorphine hydrochloride clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, 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

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
BELBUCA	FILM;BUCCAL	buprenorphine hydrochloride	207932	2016-10-24
BELBUCA	FILM;BUCCAL	buprenorphine hydrochloride	207932	2016-10-04
BELBUCA	FILM;BUCCAL	buprenorphine hydrochloride	207932	2016-09-12

US Patents and Regulatory Information for buprenorphine 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
Teva Pharms Usa	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	091149-001	Sep 8, 2014		DISCN	No	No	Start Trial	Start Trial				Start Trial
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	AB	RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Specgx Llc	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	207000-002	Dec 13, 2017	AB	RX	No	No	Start Trial	Start Trial				Start 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015	Start Trial	Start Trial
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015	Start Trial	Start Trial
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-007	Oct 23, 2015	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for buprenorphine hydrochloride

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Country	Patent Number	Estimated Expiration
Spain	2577390	Start Trial
New Zealand	594545	Start Trial
Cyprus	1117450	Start Trial
>Country	>Patent Number	>Estimated Expiration

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