Details for New Drug Application (NDA): 205637

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NDA 205637 describes BUNAVAIL, which is a drug marketed by Bdsi and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BUNAVAIL profile page.

The generic ingredient in BUNAVAIL 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.

Summary for 205637

Tradename:	BUNAVAIL
Applicant:	Bdsi
Ingredient:	buprenorphine hydrochloride; naloxone hydrochloride
Patents:	4

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM;BUCCAL			Strength	EQ 2.1MG BASE;EQ 0.3MG BASE
Approval Date:	Jun 6, 2014	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 23, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Patent:	⤷ Sign Up	Patent Expiration:	Aug 20, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Apr 24, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 205637

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014	⤷ Sign Up	⤷ Sign Up
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014	⤷ Sign Up	⤷ Sign Up
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014	⤷ Sign Up	⤷ Sign Up
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014	⤷ Sign Up	⤷ Sign Up
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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