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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 patent protection?

Buprenorphine is the generic ingredient in thirteen branded drugs marketed by Watson Labs Teva, Purdue Pharma Lp, Indivior Inc, Bdsi, Titan Pharms, 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-six NDAs. There are twenty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for buprenorphine

International Patents:	38
US Patents:	27
Tradenames:	13
Applicants:	25
NDAs:	36
Drug Master File Entries:	29
Suppliers / Packagers:	5
Bulk Api Vendors:	10
Clinical Trials:	398
Patent Applications:	6,368
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for buprenorphine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for buprenorphine
DailyMed Link:	buprenorphine at DailyMed

See drug prices for buprenorphine

Recent Clinical Trials for buprenorphine

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

Sponsor	Phase
Centre Hospitalier Universitaire de Nīmes	Phase 3
Stanford University	Phase 3
Alar Pharmaceuticals Inc.	Phase 1

See all buprenorphine clinical trials

Recent Litigation for buprenorphine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
United States v. Indivior Inc.	2019-04-09
Purdue Pharma L.P. v. Amneal Pharmaceuticals, LLC	2013-05-17
Purdue Pharma L.P. v. PAR Pharmaceutical, Inc.	2013-05-17

See all buprenorphine litigation

Generic filers with tentative approvals for BUPRENORPHINE

Applicant	Application No.	Strength	Dosage Form
		EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
		8MG	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS

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

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-[(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

Paragraph IV (Patent) Challenges for BUPRENORPHINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
BUTRANS	FILM, EXTENDED RELEASE;TRANSDERMAL	buprenorphine	021306	2013-12-16
BUTRANS	FILM, EXTENDED RELEASE;TRANSDERMAL	buprenorphine	021306	2013-06-06

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	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		RX	Yes	No			Y
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012	AB	RX	Yes	Yes			Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015		RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No			Y
Barr	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	TABLET;SUBLINGUAL	090360-001	May 7, 2010		DISCN	No	No
Alvogen Pine Brook	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	205954-004	Jan 24, 2019	AB	RX	No	No
Sun Pharm	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	TABLET;SUBLINGUAL	201760-002	Jan 29, 2016	AB	RX	No	No

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	021306-001	Jun 30, 2010
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
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	021306-003	Jun 30, 2010

International Patents for buprenorphine

Country	Patent Number	Estimated Expiration
Singapore	186200
South Africa	201209233
European Patent Office	3360538
New Zealand	604026
Israel	254417
United Kingdom	2481018
Brazil	112012031290