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Details for New Drug Application (NDA): 207932

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NDA 207932 describes BELBUCA, which is a drug marketed by Endo Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BELBUCA profile page.

The generic ingredient in BELBUCA is buprenorphine 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 profile page.

Summary for NDA: 207932

Tradename:
BELBUCA
Applicant:
Endo Pharms Inc
Ingredient:
buprenorphine hydrochloride
Patents:3
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 Endo Pharmaceuticals 63481-161 63481-161-60 60 POUCH in 1 CARTON (63481-161-60) > 1 FILM in 1 POUCH
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL 207932 NDA Endo Pharmaceuticals 63481-207 63481-207-60 60 POUCH in 1 CARTON (63481-207-60) > 1 FILM in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCALStrengthEQ 0.075MG BASE
Approval Date:Oct 23, 2015TE:RLD:No
Patent:6,159,498Patent Expiration:Oct 18, 2016Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Oct 23, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:7,579,019Patent 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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms Inc
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-004Oct 23, 20156,159,498► subscribe
Endo Pharms Inc
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-001Oct 23, 20156,159,498► subscribe
Endo Pharms Inc
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-003Oct 23, 20156,159,498► subscribe
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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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