Details for New Drug Application (NDA): 207932

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NDA 207932 describes BELBUCA, which is a drug marketed by Bdsi and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the BELBUCA profile page.

The generic ingredient in BELBUCA is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.

Summary for 207932

Tradename:	BELBUCA
Applicant:	Bdsi
Ingredient:	buprenorphine hydrochloride
Patents:	3

Pharmacology for NDA: 207932

Mechanism of Action	Partial Opioid Agonists

Suppliers and Packaging for NDA: 207932

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932	NDA	BioDelivery Sciences International Inc	59385-021	59385-021-60	60 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01)
BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932	NDA	BioDelivery Sciences International Inc	59385-022	59385-022-60	60 POUCH in 1 CARTON (59385-022-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-022-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM;BUCCAL			Strength	EQ 0.075MG BASE
Approval Date:	Oct 23, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 23, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
Patent:	⤷ Sign Up	Patent Expiration:	Jul 23, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Patent:	⤷ Sign Up	Patent Expiration:	Dec 21, 2032	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Expired US Patents for NDA 207932

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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	⤷ Sign Up	⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015	⤷ Sign Up	⤷ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-005	Oct 23, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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