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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
QuintilesIMS
Novartis
Merck
Mallinckrodt
US Department of Justice
Dow
Medtronic
Baxter

Generated: October 24, 2017

DrugPatentWatch Database Preview

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 two suppliers. There are four 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-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.

Summary for NDA: 207932

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 207932

Mechanism of ActionPartial 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 BOX (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 BOX (59385-022-60) > 1 FILM, SOLUBLE in 1 POUCH (59385-022-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCALStrengthEQ 0.075MG BASE
Approval Date:Oct 23, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 23, 2018
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:TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE

Expired Orange Book Patents for NDA: 207932

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-006Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-001Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-007Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-004Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-003Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-005Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-002Oct 23, 2015► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Moodys
Dow
Daiichi Sankyo
Fish and Richardson
Accenture
Express Scripts
AstraZeneca
Teva
QuintilesIMS
Baxter

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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