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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,147,866

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Which drugs does patent 8,147,866 protect, and when does it expire?


Patent 8,147,866 protects BELBUCA and BUNAVAIL and is included in two NDAs. There have been zero Paragraph IV challenges on Bunavail and Belbuca

This patent has thirty-six patent family members in twenty-four countries.

Summary for Patent: 8,147,866

Title:Transmucosal delivery devices with enhanced uptake
Abstract: The present invention provides methods for enhancing transmucosal uptake of a medicament, e.g., fentanyl or buprenorphine, to a subject and related devices. The method includes administering to a subject a transmucosal drug delivery device comprising the medicament. Also provided are devices suitable for transmucosal administration of a medicament to a subject and methods of their administration and use. The devices include a medicament disposed in a mucoadhesive polymeric diffusion environment and a barrier environment.
Inventor(s): Finn; Andrew (Raleigh, NC), Vasisht; Niraj (Cary, NC)
Assignee: BioDelivery Sciences International, Inc. (Raleigh, NC)
Application Number:13/184,306
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-001Oct 23, 2015RXYesNo► Subscribe► SubscribeYTREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-002Oct 23, 2015RXYesNo► Subscribe► SubscribeYTREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-003Oct 23, 2015RXYesNo► Subscribe► SubscribeYTREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-004Oct 23, 2015RXYesNo► Subscribe► SubscribeYTREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-005Oct 23, 2015RXYesNo► Subscribe► SubscribeYTREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-006Oct 23, 2015RXYesNo► Subscribe► SubscribeYTREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE► Subscribe
BdsiBELBUCAbuprenorphine hydrochlorideFILM;BUCCAL207932-007Oct 23, 2015RXYesYes► Subscribe► SubscribeYTREATEMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE► Subscribe
BdsiBUNAVAILbuprenorphine hydrochloride; naloxone hydrochlorideFILM;BUCCAL205637-001Jun 6, 2014RXYesNo► Subscribe► SubscribeYMAINTENANCE TREATMENT OF OPIOID DEPENDENCE► Subscribe
BdsiBUNAVAILbuprenorphine hydrochloride; naloxone hydrochlorideFILM;BUCCAL205637-002Jun 6, 2014RXYesNo► Subscribe► SubscribeYMAINTENANCE TREATMENT OF OPIOID DEPENDENCE► Subscribe
BdsiBUNAVAILbuprenorphine hydrochloride; naloxone hydrochlorideFILM;BUCCAL205637-003Jun 6, 2014RXYesYes► Subscribe► SubscribeYMAINTENANCE TREATMENT OF OPIOID DEPENDENCE► Subscribe
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Non-Orange Book Patents for Patent: 8,147,866

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
9,597,288Transmucosal delivery devices with enhanced uptake► Subscribe
9,655,843Transmucosal 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 Patent: 8,147,866

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2007275581► Subscribe
BrazilPI0714712► Subscribe
Canada2658585► Subscribe
China101511337► Subscribe
China103550136► Subscribe
Cyprus1117450► Subscribe
Denmark2054031► Subscribe
European Patent Office2054031► Subscribe
European Patent Office3067044► Subscribe
Spain2577390► 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:

Federal Trade Commission
Argus Health
Medtronic
Daiichi Sankyo
McKinsey
Baxter
Mallinckrodt
Covington
Chubb
UBS

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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