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Serving leading biopharmaceutical companies globally:

Colorcon
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Dow
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Generated: December 17, 2017

DrugPatentWatch Database Preview

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 six 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-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for 205637

Tradename:1
Applicant:1
Ingredient:1
Patents:6
Formulation / Manufacturing:see details

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)

Summary 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
Regulatory Exclusivity Expiration:Jun 6, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent Expiration:Oct 18, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jan 22, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF OPIOID DEPENDENCE

Expired Orange Book Patents for NDA: 205637

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
BdsiBUNAVAILbuprenorphine hydrochloride; naloxone hydrochlorideFILM;BUCCAL205637-003Jun 6, 2014► Subscribe► Subscribe
BdsiBUNAVAILbuprenorphine hydrochloride; naloxone hydrochlorideFILM;BUCCAL205637-001Jun 6, 2014► Subscribe► Subscribe
BdsiBUNAVAILbuprenorphine hydrochloride; naloxone hydrochlorideFILM;BUCCAL205637-002Jun 6, 2014► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Deloitte
Harvard Business School
Argus Health
Mallinckrodt
Cipla
Dow
Teva
Express Scripts
McKinsey
Baxter

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