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Last Updated: October 15, 2019

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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 eighty-nine 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. Nineteen 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

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Recent Clinical Trials for BELBUCA

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SponsorPhase
Indivior Inc.Phase 4
PRA Health SciencesPhase 1
BioDelivery Sciences InternationalPhase 1

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Recent Litigation for BELBUCA

Identify potential future generic entrants

District Court Litigation
Case NameDate
BIODELIVERY SCIENCES INTERNATIONAL, INC. v. CHEMO RESEARCH, S.L.2019-03-15
BioDelivery Sciences International, Inc. v. Chemo Research, S.L.2019-03-01
BioDelivery Sciences International, Inc. v. Alvogen Pb Research & Development LLC2018-09-07

See all BELBUCA litigation

PTAB Litigation
PetitionerDate
MONOSOL RX, LLC2014-01-22

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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

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   See Pricing   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 RX Yes No   See Pricing   See Pricing Y   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 RX Yes No   See Pricing   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 RX Yes No   See Pricing   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 RX Yes No   See Pricing   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 RX Yes No   See Pricing   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 RX Yes No   See Pricing   See Pricing Y   See Pricing
>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 207932-002 Oct 23, 2015   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-004 Oct 23, 2015   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 Oct 23, 2015   See Pricing   See Pricing
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for BELBUCA
Drugname Dosage Strength RLD Date
➤ Subscribe Buccal Film 75 mcg and 150 mcg ➤ Subscribe   See Pricing
➤ Subscribe Buccal Film 300 mcg, 450 mcg, 600 mcg and 750 mcg ➤ Subscribe   See Pricing
➤ Subscribe Buccal Film 900 mcg ➤ Subscribe   See Pricing

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Colorcon
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McKesson
Express Scripts
Merck

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