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Last Updated: December 16, 2019

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Buprenorphine hydrochloride - Generic Drug Details

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What are the generic sources for buprenorphine hydrochloride and what is the scope of patent protection?

Buprenorphine hydrochloride is the generic ingredient in ten branded drugs marketed by Bdsi, Titan Pharms, Indivior Inc, Am Regent, Hospira, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Casi Pharms Inc, Ethypharm, Mylan, Rhodes Pharms, Sun Pharm, Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, and Orexo Us Inc, and is included in thirty-three NDAs. There are twenty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride has one hundred and nine patent family members in thirty countries.

There are twenty-nine drug master file entries for buprenorphine hydrochloride. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for buprenorphine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Centre Hospitalier Universitaire de NÄ«mesPhase 3
Heffter Research InstitutePhase 1
University of Wisconsin, MadisonPhase 1

See all buprenorphine hydrochloride clinical trials

Recent Litigation for buprenorphine hydrochloride

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 buprenorphine hydrochloride litigation

PTAB Litigation
PetitionerDate
MONOSOL RX, LLC2014-01-22

See all buprenorphine hydrochloride litigation

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 8MG BASE;EQ 2MG BASEFILM;BUCCAL, SUBLINGUAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for buprenorphine hydrochloride
Synonyms for buprenorphine hydrochloride
(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
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, (5-alpha,7-alpha(S))-
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
AC1L9B1P
AC1MHV55
AKOS024457300
BCP16140
Belbuca
BEMA LA
BEMA long acting analgesic
BEMA-buprenorphine
Buprenex (TN)
buprenorphine
Buprenorphine (hydrochloride)
Buprenorphine Depot
Buprenorphine Hcl
Buprenorphine hydrochloride (JP17/USP)
Buprenorphine hydrochloride [USAN:JAN]
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
Buprex
Butrans
C29H41NO4.HCl
CAS-53152-21-9
CHEBI:652822
CHEMBL1200401
CHEMBL1894325
CHEMBL2368861
CL 112,302
CL 112302
CL-112302
CL112302
CS-2940
D00836
DEA No. 9064
DSSTox_CID_28831
DSSTox_GSID_48905
DSSTox_RID_83100
DTXSID2048905
EINECS 258-396-8
ETI-311
Finibron
FTB-8127
HY-B0701
IX-1003
IX-1004
IX-1005
Lepetan
LS-67683
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
Temgesic
Tox21_112899
Transtec
TSN-09
U- 952
UAIXRPCCYXNJMQ-HPRIMLMLSA-N
UM 952
UM-952
UNII-56W8MW3EN1
V-1003
V-1004
V-1005
Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE
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 buprenorphine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-002 Oct 23, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Indivior Inc SUBUTEX buprenorphine hydrochloride TABLET;SUBLINGUAL 020732-003 Oct 8, 2002 DISCN 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 buprenorphine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015   Start Trial   Start Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-007 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 207932-003 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 207932-004 Oct 23, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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