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Buprenorphine - Generic Drug Details

What are the generic sources for buprenorphine and what is the scope of buprenorphine freedom to operate?

Buprenorphine is the generic ingredient in twelve branded drugs marketed by 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-four 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.

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

Summary for buprenorphine

US Patents:	25
Tradenames:	12
Applicants:	23
NDAs:	34
Drug Master File Entries:	29
Suppliers / Packagers:	5
Bulk Api Vendors:	10
Clinical Trials:	369
Patent Applications:	6,709
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for buprenorphine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for buprenorphine
DailyMed Link:	buprenorphine at DailyMed

Pharmacology for buprenorphine

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for buprenorphine

Analgesics, Opioid
Narcotic Antagonists
Narcotics

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

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Glossary

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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	Y			➤ Sign Up
Lannett Co Inc	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	205022-001	Sep 19, 2016	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	AB	RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-005	Oct 23, 2015		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Indivior Inc	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-001	Nov 30, 2017		RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Mylan Technologies	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	207607-002	Jun 14, 2018	AB	RX	No	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

Expired US Patents for buprenorphine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010	➤ Sign Up	➤ Sign Up
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010	➤ Sign Up	➤ Sign Up
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010	➤ Sign Up	➤ Sign Up
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-004	Jul 25, 2013	➤ Sign Up	➤ Sign Up
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010	➤ Sign Up	➤ Sign Up
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

International Patents for buprenorphine

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Country	Document Number	Estimated Expiration
Russian Federation	2012157244	➤ Sign Up
Japan	5986072	➤ Sign Up
China	103079544	➤ Sign Up
Brazil	112012031290	➤ Sign Up
Singapore	186200	➤ Sign Up
United Kingdom	201413064	➤ Sign Up
Country	Document Number	Estimated Expiration