Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 11, 2019

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 one supplier. 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. Eighteen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
Summary for 207932
Tradename:BELBUCA
Applicant:Bdsi
Ingredient:buprenorphine hydrochloride
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)
Paragraph IV (Patent) Challenges for 207932
Tradename Dosage Ingredient NDA Submissiondate
BELBUCA FILM;BUCCAL buprenorphine hydrochloride 207932 2016-10-24
BELBUCA FILM;BUCCAL buprenorphine hydrochloride 207932 2016-10-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCALStrengthEQ 0.075MG BASE
Approval Date:Oct 23, 2015TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jan 22, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
Patent:  Start TrialPatent Expiration:Jul 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
Patent:  Start TrialPatent Expiration:Jul 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Expired US Patents for NDA 207932

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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