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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Chubb
Argus Health
Medtronic
McKesson
Harvard Business School
AstraZeneca
Daiichi Sankyo
Cantor Fitzgerald

Generated: June 25, 2018

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 eighty-five 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. Twenty-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
Drug patent expirations by year for BELBUCA
Pharmacology for BELBUCA
Synonyms for BELBUCA
(2S)-2-[17-(Cyclopropylmethyl)-4,5a-epoxy-3-hydroxy-6-methoxy-6a,14-ethano-14a-morphinan-7a-yl]-3,3-dimethylbutan-2-ol hydrochloride
(5alpha,7alpha(S))-alpha-tert-Butyl-17-(cyclopropylmethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-6,14-ethenomorphinan-7-methanol hydrochloride
[5?,7?(S)]-17-(Cyclopropylmethyl)-?-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-?-methyl-6,14-ethenomorphinan-7-methanol hydrochloride
[5|A,7|A(S)]-17-(Cyclopropylmethyl)-|A-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-|A-methyl-6,14-ethenomorphinan-7-methanol Hydrochloride
[5|A,7|A(S)]-17-(Cyclopropylmethyl)-|A-(1,1-dimethylethyl)4,5-epoxy-18,19-dihydo-3-hydroxy-6-methoxy-|A-methyl-6,14-ethenomorphinan-7-methanol hydrochloride
21-Cyclopropyl-7alpha-((S)-1-hydroxy-1,2,2-trimethylpropyl)-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine hydrochloride
53152-21-9
56W8MW3EN1
6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-alpha-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-, hydrochloride, (5alpha,7alpha(S))-
AKOS024457300
Buprenex (TN)
buprenorphine
Buprenorphine (hydrochloride)
Buprenorphine Hcl
BUPRENORPHINE HYDROCHLORIDE
Buprenorphine hydrochloride (JP17/USP)
Buprenorphine hydrochloride [USAN:USP:JAN]
Buprenorphine hydrochloride solution
Buprenorphine hydrochloride solution, analytical standard, for drug analysis
Buprenorphine hydrochloride, British Pharmacopoeia (BP) Reference Standard
Buprenorphine Hydrochloride, pharmaceutical secondary standard; traceable to USP, PhEur
Buprenorphine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Buprex
Butrans
CAS-53152-21-9
CHEBI:652822
CHEMBL1894325
CHEMBL2368861
CL 112,302
CL 112302
CL-112302
CL112302
CS-2940
DEA No. 9064
DSSTox_CID_28831
DSSTox_GSID_48905
DSSTox_RID_83100
DTXSID2048905
EINECS 258-396-8
Finibron
FTB-8127
HY-B0701
Lepetan
MLS002320704
MR 56
NCGC00247733-01
NIH 8805
NIH-8805
NIH8805
Norspan
RX 6029-M
RX 6029-M HCl
RX-6029-M
RX-6029M HCL
SCHEMBL17220698
SCHEMBL17220699
SCHEMBL42107
SMR001338850
Subutex
Tox21_112899
U- 952
UAIXRPCCYXNJMQ-HPRIMLMLSA-N
UM 952
UM-952
UNII-56W8MW3EN1

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

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Expired US Patents for BELBUCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for BELBUCA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Buccal Film 75 mcg and 150 mcg ➤ Subscribe 2016-10-24
➤ Subscribe Buccal Film 300 mcg, 450 mcg, 600 mcg and 750 mcg ➤ Subscribe 2016-10-04
➤ Subscribe Buccal Film 900 mcg ➤ Subscribe 2016-09-12

Non-Orange Book US Patents for 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 ➤ Sign Up
9,597,288 Transmucosal delivery devices with enhanced uptake ➤ Sign Up
2,017,035,688 ➤ Sign Up
6,159,498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Moodys
US Army
Covington
Johnson and Johnson
McKinsey
US Department of Justice
Harvard Business School
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 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.