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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Merck
Fish and Richardson
Argus Health
Cantor Fitzgerald
Express Scripts
Colorcon
QuintilesIMS
Cipla
US Department of Justice

Generated: August 23, 2017

DrugPatentWatch Database Preview

BELBUCA Drug Profile

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What is the patent landscape for 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 sixty-three patent family members in twenty-seven countries.

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 Tradename: BELBUCA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list16
Clinical Trials: see list5
Patent Applications: see list702
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BELBUCA at DailyMed

Pharmacology for Tradename: 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;BUCCAL207932-007Oct 23, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-006Oct 23, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-007Oct 23, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-006Oct 23, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-001Oct 23, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: BELBUCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-006Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-003Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-007Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-001Oct 23, 2015► Subscribe► Subscribe
Bdsi
BELBUCA
buprenorphine hydrochloride
FILM;BUCCAL207932-004Oct 23, 2015► Subscribe► Subscribe
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Paragraph IV activity for: BELBUCA

Drugname Dosage Strength RLD Submissiondate
buprenorphine hydrochlorideBuccal Film75 mcg and 150 mcgBelbuca10/24/2016
buprenorphine hydrochlorideBuccal Film300 mcg, 450 mcg, 600 mcg and 750 mcgBelbuca10/4/2016
buprenorphine hydrochlorideBuccal Film900 mcgBelbuca9/12/2016

Non-Orange Book Patents for Tradename: BELBUCA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,800,832 Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces► Subscribe
9,597,288Transmucosal delivery devices with enhanced uptake► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: BELBUCA

Country Document Number Estimated Expiration
New Zealand574361► Subscribe
Japan4619894► Subscribe
Denmark2054031► Subscribe
Poland2054031► Subscribe
Hong Kong1193566► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
AstraZeneca
Dow
McKesson
Federal Trade Commission
Johnson and Johnson
Chubb
US Department of Justice
Citi
QuintilesIMS

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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