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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Deloitte
Covington
Cipla
McKesson
Julphar
AstraZeneca
Argus Health
Baxter
Novartis

Generated: December 14, 2017

DrugPatentWatch Database Preview

BELBUCA Drug Profile

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When do Belbuca patents expire, 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-nine patent family members in twenty-seven countries.

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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-007Oct 23, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-006Oct 23, 2015RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-007Oct 23, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-006Oct 23, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-001Oct 23, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-004Oct 23, 2015RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-005Oct 23, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-002Oct 23, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-001Oct 23, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-003Oct 23, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: BELBUCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-005Oct 23, 2015► Subscribe► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-001Oct 23, 2015► Subscribe► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-002Oct 23, 2015► Subscribe► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-006Oct 23, 2015► Subscribe► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-003Oct 23, 2015► Subscribe► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-004Oct 23, 2015► Subscribe► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-007Oct 23, 2015► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
European Patent Office2054031► Subscribe
Denmark0973497► Subscribe
Denmark1079813► Subscribe
European Patent Office3067044► Subscribe
World Intellectual Property Organization (WIPO)9817251► Subscribe
Germany69717862► Subscribe
Portugal973497► Subscribe
World Intellectual Property Organization (WIPO)9955312► Subscribe
Australia3892401► Subscribe
Australia3967899► 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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Serving leading biopharmaceutical companies globally:

Dow
Julphar
Fuji
Cerilliant
Citi
Farmers Insurance
McKinsey
Harvard Business School
Johnson and Johnson
Merck

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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