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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
US Department of Justice
Citi
Farmers Insurance
Healthtrust
Cipla
McKesson
Mallinckrodt
Baxter

Generated: August 18, 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-eight 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 NDA: 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
Patent:► SubscribePatent Expiration:Oct 18, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Aug 20, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Apr 24, 2035Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 205637

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-003Jun 6, 2014► Subscribe► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 2014► Subscribe► Subscribe
Bdsi
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-002Jun 6, 2014► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Julphar
Medtronic
Fuji
US Army
Argus Health
UBS
Johnson and Johnson
Covington
Fish and Richardson
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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