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Last Updated: December 6, 2019

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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. It is available from one supplier. There are five 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 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:5
Pharmacology for NDA: 205637
Suppliers and Packaging for NDA: 205637
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637 NDA BioDelivery Sciences International, Inc. 59385-012 59385-012-30 30 POUCH in 1 BOX (59385-012-30) > 1 FILM in 1 POUCH (59385-012-01)
BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637 NDA BioDelivery Sciences International, Inc. 59385-014 59385-014-30 30 POUCH in 1 BOX (59385-014-30) > 1 FILM in 1 POUCH (59385-014-01)
Paragraph IV (Patent) Challenges for 205637
Tradename Dosage Ingredient NDA Submissiondate
BUNAVAIL FILM;BUCCAL buprenorphine hydrochloride; naloxone hydrochloride 205637 2016-11-23
BUNAVAIL FILM;BUCCAL buprenorphine hydrochloride; naloxone hydrochloride 205637 2015-12-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCALStrengthEQ 2.1MG BASE;EQ 0.3MG BASE
Approval Date:Jun 6, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jan 22, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Patent:  Start TrialPatent Expiration:Jul 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Patent:  Start TrialPatent Expiration:Aug 20, 2032Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 205637

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

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