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Generated: May 23, 2019

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Buprenorphine - Generic Drug Details

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

Buprenorphine is the generic ingredient in thirteen branded drugs marketed by Watson Labs Teva, Purdue Pharma Lp, Indivior Inc, Bdsi, Titan Pharms, Hospira, Luitpold, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Casi Pharms Inc, Ethypharm, Mylan Pharms Inc, Rhodes Pharms, Sun Pharm Inds Ltd, 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-six NDAs. There are twenty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has thirty-seven patent family members in twenty-six countries.

There are twenty-nine drug master file entries for buprenorphine. Five suppliers are listed for this compound.

Pharmacology for buprenorphine
Medical Subject Heading (MeSH) Categories for buprenorphine
Synonyms for buprenorphine
(-)-buprenorphine
(1S,2R,6S,14R,15R,16R)-3-(cyclopropylmethyl)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-3-azahexacyclo[13.2.2.1^{2,8}.0^{1,6}.0^{6,14}.0^{7,12}]icosa-7(12),8,10-trien-11-ol
(1S,2R,6S,14R,15R,16R)-3-(cyclopropylmethyl)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-3-azahexacyclo[13.2.2.1;{2,8}.0;{1,6}.0;{6,14}.0;{7,12}]icosa-7,9,11-trien-11-ol
(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
[5alpha,7alpha(S)]-
[5alpha,7alpha(S)]-17-(Cyclopropylmethyl)-alpha-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-6,14-ethenomorphinan-7-methanol
17-Cyclopropylmethyl-4,5alpha-epoxy-7alpha-((S)-1-hydroxy-1,2,2-trimethylpropyl-6-methoxy-6,14-endo-ethanomorphinan-3-ol
17-cyclopropylmethyl-4,5alpha-epoxy-7alpha-((S)-1-hydroxy-1,2,2-trimethylpropyl)-6-methoxy-6,14-endo-ethanomorphinan-3-ol
2-(N-cyclopropylmethyl-4,5alpha-epoxy-3-hydroxy-6-methoxy-6,14-endo-ethanomorphinan-6alpha-yl)-3,3-dimethyl-2-butanol
2-(N-Cyclopropylmethyl-4,5alpha-epoxy-3-hydroxy-6-methoxy-6,14-endo-ethanomorphinan-7alpha-yl)-3,3-dimethyl-2-butanol
2-[3-cyclopropylmethyl-11-hydroxy-15-methoxy-(14R)-13-oxa-3-azahexacyclo[13.2.2.12,8.01,6.06,14.07,12]icosa-7,9,11-trien-16-yl]-3,3-dimethyl-2-butanol
21-(Cyclopropyl-7alpha-((S)-1-hydroxy-1,2,2-trimethylpropyl-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine
21-cyclopropyl-7alpha-(2-hydroxy-3,3-dimethyl-2-butyl)-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine
21-cyclopropyl-7alpha-[(S)-1-hydroxy-1,2,2-trimethylpropyl]-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine
40D3SCR4GZ
52485-79-7
53152-21-9 (hydrochloride)
6,14-ethenomorphinan-3-ol, 17-(cyclopropylmethyl)-4,5-epoxy-18,19-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-methoxy-, (5alpha,7alpha)-
6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-alpha-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-,
6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-alpha-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-, (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-, (alphaS,5alpha,7alpha)- (9CI)
6029-M
AC1LD8IH
BDBM50026603
BEMA
Buprel
Buprenex
Buprenex, Subutex, Suboxone, Butrans
Buprenophine
Buprenorfina
Buprenorfina [INN-Spanish]
Buprenorphine (JAN/INN)
Buprenorphine [INN:BAN:JAN]
Buprenorphine Hcl
Buprenorphinum
Buprenorphinum [INN-Latin]
Butrans
Buvidal
C-22673
C08007
CAM2038
CC-25269
CHEBI:3216
CHEMBL560511
D07132
DB00921
DEA No. 9064
DTXSID2022705
EINECS 257-950-6
GTPL1670
Probuphenine
Probuphine
RBP-6000
RX 6029M
SCHEMBL15821
Sublocade
Subutex
Temgesic
Temgesic (TN)
UNII-40D3SCR4GZ
ZINC1319780

US Patents and Regulatory Information for buprenorphine

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 207932-001 Oct 23, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Technologies BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 207607-002 Jun 14, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-001 Aug 30, 2010 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Indivior Inc SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410-004 Aug 10, 2012 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 buprenorphine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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