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Last Updated: January 24, 2020

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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 ninety-four 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. Sixteen 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

Recent Litigation for BELBUCA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Aquestive Therapeutics, Inc. v. BioDelivery Sciences International, Inc.2019-11-11
BIODELIVERY SCIENCES INTERNATIONAL, INC. v. CHEMO RESEARCH, S.L.2019-03-15
BioDelivery Sciences International, Inc. v. Chemo Research, S.L.2019-03-01

See all BELBUCA litigation

PTAB Litigation
PetitionerDate
MONOSOL RX, LLC2014-01-22

See all BELBUCA litigation

Pharmacology for BELBUCA
Synonyms for BELBUCA
(-)-buprenorphine hydrochloride
(5alpha,6beta,14beta,18R)-17-(cyclopropylmethyl)-18-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-6-methoxy-18,19-dihydro-4,5-epoxy-6,14-ethenomorphinan-3-ol hydrochloride
(5alpha,6beta,14beta,18R)-17-(cyclopropylmethyl)-3-hydroxy-18-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-6-methoxy-18,19-dihydro-4,5-epoxy-6,14-ethenomorphinan-17-ium chloride
(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|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
17-cyclopropylmethyl-4,5alpha-epoxy-7alpha-((S)-1-hydroxy-1,2,2-trimethylpropyl)-6-methoxy-6,14-endo-ethanomorphinan-3-ol hydrochloride
2-(N-cyclopropylmethyl-4,5alpha-epoxy-3-hydroxy-6-methoxy-6,14-endo-ethanomorphinan-6alpha-yl)-3,3-dimethyl-2-butanol hydrochloride
21-Cyclopropyl-7alpha-((S)-1-hydroxy-1,2,2-trimethylpropyl)-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine hydrochloride
21-cyclopropyl-7alpha-[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine hydrochloride
52485-79-7
52485-79-7 (Parent)
53152-21-9
53187-13-6
55327-62-3
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))-
64425-21-4
AC1MHV55
BCP16140
BEMA LA
BEMA long acting analgesic
BEMA-buprenorphine
Buprenex (TN)
buprenorphine
Buprenorphine (hydrochloride)
Buprenorphine Depot
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; Certified Reference Material
Buprenorphine hydrochloride, United States Pharmacopeia (USP) Reference Standard
buprenorphine hydrochlorie
Buprex
Butrans
CHEBI:652822
CHEMBL1200401
CL 112,302
CL 112302
CL-112302
CL112302
CS-2940
D00836
DEA No. 9064
DTXSID2048905
EINECS 258-396-8
ETI-311
Finibron
FTB-8127
HY-B0701
IX-1003
IX-1004
IX-1005
MR 56
NIH 8805
NIH-8805
NIH8805
Norspan
RX 6029-M
RX 6029-M HCl
RX-6029-M
SCHEMBL17220698
Subutex
Temgesic
Transtec
TSN-09
UM 952
UM-952
UNII-56W8MW3EN1
V-1003
V-1004
V-1005
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

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   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 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 207932-006 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 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 207932-005 Oct 23, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Johnson and Johnson
Medtronic
Moodys
Baxter

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