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, Alvogen, Titan Pharms, Indivior Inc, Am Regent, Hikma, Hospira, Par Sterile Products, Actavis Elizabeth, Barr, Ethypharm, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, Aveva, 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 NDAs. There are twenty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride has ninety-one patent family members in twenty-eight countries.

There are sixteen drug master file entries for buprenorphine hydrochloride. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for buprenorphine hydrochloride

International Patents:	91
US Patents:	24
Tradenames:	10
Applicants:	27
NDAs:	40
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	481
Patent Applications:	1,367
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
Elina Brinck	Phase 1
Icahn School of Medicine at Mount Sinai	Phase 3
Royal Victoria Hospital, Canada	Phase 4

See all buprenorphine hydrochloride clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
See Plans and Pricing	See Plans and Pricing	EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET;SUBLINGUAL
See Plans and Pricing	See Plans and Pricing	EQ 2.9MG BASE;EQ 0.71MG 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 hydrochloride

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

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

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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
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	AB	RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Mylan Technologies	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	207607-002	Jun 14, 2018	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Indivior Inc	SUBUTEX	buprenorphine hydrochloride	TABLET;SUBLINGUAL	020732-003	Oct 8, 2002		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	207932-005	Oct 23, 2015	See Plans and Pricing	See Plans and Pricing
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015	See Plans and Pricing	See Plans and Pricing
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-007	Oct 23, 2015	See Plans and Pricing	See Plans and Pricing
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-006	Oct 23, 2015	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for buprenorphine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
China	104125828	Transmucosal drug delivery devices for use in chronic pain relief	See Plans and Pricing
Japan	5448814		See Plans and Pricing
Japan	5689144		See Plans and Pricing
Japan	2013151549	TRANSMUCOSAL DELIVERY DEVICE WITH ENHANCED UPTAKE	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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