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Generated: December 10, 2018

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BELBUCA Drug Profile

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Which patents cover Belbuca, 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
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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 207932-005 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 207932-002 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-006 Oct 23, 2015 ➤ Sign Up ➤ Sign Up
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 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 Date
➤ Subscribe Buccal Film 75 mcg and 150 mcg ➤ Subscribe ➤ Sign Up
➤ Subscribe Buccal Film 300 mcg, 450 mcg, 600 mcg and 750 mcg ➤ Subscribe ➤ Sign Up
➤ Subscribe Buccal Film 900 mcg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
AstraZeneca
Cipla
Express Scripts
Chubb
Queensland Health
Farmers Insurance
Baxter

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