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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 eleven 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, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Teva Pharms Usa, and Orexo Us Inc, and is included in thirty-three 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.

Summary for buprenorphine

International Patents:	24
US Patents:	25
Tradenames:	11
Applicants:	23
NDAs:	33
Drug Master File Entries:	29
Suppliers / Packagers:	5
Bulk Api Vendors:	11
Clinical Trials:	353
Patent Applications:	6,683
Formulation / Manufacturing:	see details
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indivior Inc	SUBLOCADE	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	209819-002	Nov 29, 2017		RX	Yes	Yes
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012	AB	RX	Yes	Yes			Y
Lannett Co Inc	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	205022-002	Sep 19, 2016	AB	RX	No	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No

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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	021306-005	Jun 30, 2014
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-004	Jul 25, 2013

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International Patents for buprenorphine

Country	Document Number	Estimated Expiration
Japan	5986072
United Kingdom	2481018
Colombia	6670529
South Africa	201209233