➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Johnson and Johnson
Mallinckrodt
Colorcon
Baxter

Last Updated: August 14, 2020

DrugPatentWatch Database Preview

BELBUCA Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

Which patents cover Belbuca, and when can generic versions of Belbuca launch?

Belbuca is a drug marketed by Bdsi and is included in one NDA. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has ninety-six patent family members in thirty countries.

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.

Drug patent expirations by year for BELBUCA
Drug Prices for BELBUCA

See drug prices for BELBUCA

Recent Clinical Trials for BELBUCA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Indivior Inc.Phase 4
PRA Health SciencesPhase 1
BioDelivery Sciences InternationalPhase 1

See all BELBUCA clinical trials

Pharmacology for BELBUCA
Paragraph IV (Patent) Challenges for BELBUCA
Tradename Dosage Ingredient NDA Submissiondate
BELBUCA FILM;BUCCAL buprenorphine hydrochloride 207932 2016-10-24
BELBUCA FILM;BUCCAL buprenorphine hydrochloride 207932 2016-10-04
BELBUCA FILM;BUCCAL buprenorphine hydrochloride 207932 2016-09-12

US Patents and Regulatory Information for BELBUCA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for BELBUCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 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

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

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Merck
Boehringer Ingelheim
Colorcon
Medtronic

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 verification 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.