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Buprenorphine hydrochloride - Generic Drug Details

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

Buprenorphine hydrochloride is the generic ingredient in nine branded drugs marketed by Bdsi, Titan Pharms, Indivior Inc, 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-one NDAs. There are nineteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for buprenorphine hydrochloride

US Patents:	19
Tradenames:	9
Applicants:	22
NDAs:	31
Drug Master File Entries:	29
Suppliers / Packagers:	22
Bulk Api Vendors:	29
Clinical Trials:	353
Patent Applications:	6,622
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for buprenorphine hydrochloride
DailyMed Link:	buprenorphine hydrochloride at DailyMed

Pharmacology for buprenorphine hydrochloride

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Synonyms for buprenorphine hydrochloride

(2S)-2-[17-(Cyclopropylmethyl)-4,5a-epoxy-3-hydroxy-6-methoxy-6a,14-ethano-14a-morphinan-7a-yl]-3,3-dimethylbutan-2-ol hydrochloride

(5alpha,7alpha(S))-alpha-tert-Butyl-17-(cyclopropylmethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-6,14-ethenomorphinan-7-methanol hydrochloride

[5?,7?(S)]-17-(Cyclopropylmethyl)-?-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-?-methyl-6,14-ethenomorphinan-7-methanol hydrochloride

[5|A,7|A(S)]-17-(Cyclopropylmethyl)-|A-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-|A-methyl-6,14-ethenomorphinan-7-methanol Hydrochloride

[5|A,7|A(S)]-17-(Cyclopropylmethyl)-|A-(1,1-dimethylethyl)4,5-epoxy-18,19-dihydo-3-hydroxy-6-methoxy-|A-methyl-6,14-ethenomorphinan-7-methanol hydrochloride

21-Cyclopropyl-7alpha-((S)-1-hydroxy-1,2,2-trimethylpropyl)-6,14-endo-ethano-6,7,8,14-tetrahydrooripavine hydrochloride

53152-21-9

56W8MW3EN1

6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-alpha-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-, hydrochloride, (5alpha,7alpha(S))-

AKOS024457300

Belbuca

Buprenex (TN)

buprenorphine

Buprenorphine (hydrochloride)

Buprenorphine Hcl

Buprenorphine hydrochloride (JP17/USP)

Buprenorphine hydrochloride [USAN:USP:JAN]

Buprenorphine hydrochloride solution

Buprenorphine hydrochloride solution, analytical standard, for drug analysis

Buprenorphine hydrochloride, British Pharmacopoeia (BP) Reference Standard

Buprenorphine Hydrochloride, pharmaceutical secondary standard; traceable to USP, PhEur

Buprenorphine hydrochloride, United States Pharmacopeia (USP) Reference Standard

Buprex

Butrans

CAS-53152-21-9

CHEBI:652822

CHEMBL1894325

CHEMBL2368861

CL 112,302

CL 112302

CL-112302

CL112302

CS-2940

DEA No. 9064

DSSTox_CID_28831

DSSTox_GSID_48905

DSSTox_RID_83100

DTXSID2048905

EINECS 258-396-8

Finibron

FTB-8127

HY-B0701

Lepetan

MLS002320704

MR 56

NCGC00247733-01

NIH 8805

NIH-8805

NIH8805

Norspan

RX 6029-M

RX 6029-M HCl

RX-6029-M

RX-6029M HCL

SCHEMBL17220698

SCHEMBL17220699

SCHEMBL42107

SMR001338850

Subutex

Tox21_112899

U- 952

UAIXRPCCYXNJMQ-HPRIMLMLSA-N

UM 952

UM-952

UNII-56W8MW3EN1

US Patents and Regulatory Information for buprenorphine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ethypharm	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	TABLET;SUBLINGUAL	090622-002	Sep 24, 2010	AB	RX	No	No
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-006	Oct 23, 2015		RX	Yes	No
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-002	Oct 23, 2015		RX	Yes	No
Indivior Inc	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	AB	RX	Yes	No			Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No

Expired US Patents for buprenorphine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-007	Oct 23, 2015
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-005	Oct 23, 2015

International Patents for buprenorphine hydrochloride

Country	Document Number	Estimated Expiration
Mexico	PA04011875
Japan	2002512950
Australia	729516
Australia	2017258916
Japan	4619894