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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 Bdsi and is included in one NDA. It is available from one supplier. There are three 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-eight 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

buprenorphine hydrochloride
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
buprenorphine hydrochloride
FILM;BUCCAL 207932 NDA Endo Pharmaceuticals, Inc. 63481-161 63481-161-60 60 POUCH in 1 CARTON (63481-161-60) > 1 FILM in 1 POUCH
buprenorphine hydrochloride
FILM;BUCCAL 207932 NDA Endo Pharmaceuticals, Inc. 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:Yes
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?

Expired Orange Book Patents for NDA: 207932

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
buprenorphine hydrochloride
FILM;BUCCAL207932-007Oct 23, 20156,159,498► subscribe
buprenorphine hydrochloride
FILM;BUCCAL207932-005Oct 23, 20156,159,498► subscribe
buprenorphine hydrochloride
FILM;BUCCAL207932-004Oct 23, 20156,159,498► subscribe
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