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Baxter
Dow
Moodys
US Army
McKinsey
Chinese Patent Office
Johnson and Johnson
Healthtrust
Cerilliant

Generated: January 19, 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, 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-five NDAs. There are twenty-five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has twenty-four patent family members in sixteen 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-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-(methyloxy)-18,19-dihydro-4,5-epoxy-6,14-ethenomorphinan-3-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)
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 (TN)
Buprenex, Subutex, Suboxone, Butrans
Buprenophine
Buprenorfina
Buprenorfina [INN-Spanish]
buprenorfine
Buprenorphine (JAN/INN)
Buprenorphine [INN:BAN:JAN]
Buprenorphine [INN:BAN]
Buprenorphine Hcl
Buprenorphinum
Buprenorphinum [INN-Latin]
Butrans
C-22673
C08007
CAM2038
CC-25269
CHEBI:3216
CHEMBL560511
D06AWE
DB00921
DEA No. 9064
DTXSID2022705
EINECS 257-950-6
GTPL1670
Norspan
Probuphenine
Probuphine
RBP-6000
RX 6029M
RX-6029-M
SCHEMBL15821
Sublocade
Suboxone? (TN)
Subutex
Subutex (TN)
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 207932-006 Oct 23, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Indivior Inc SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-001 Nov 30, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Amneal Pharms BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 203136-001 Feb 22, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Indivior Inc SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819-002 Nov 30, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Dr Reddys Labs Sa BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 205806-002 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 022410-004 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 021306-001 Jun 30, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-005 Jun 30, 2014 ➤ 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 021306-002 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for buprenorphine

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Harvard Business School
Dow
Cipla
Argus Health
Queensland Health
Fuji
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.