Get our Free Patent Expiration, Litigation, and Drug Price Updates

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
QuintilesIMS
Queensland Health
Baxter
Moodys

Generated: June 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207932

« Back to Dashboard

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. Twenty-two 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCALStrengthEQ 0.075MG BASE
Approval Date:Oct 23, 2015TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 22, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
Patent:➤ Try a Free TrialPatent Expiration:Jul 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
Patent:➤ Try a Free 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 207932-004 Oct 23, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Boehringer Ingelheim
McKinsey
Chubb
Chinese Patent Office

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.