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Sugammadex sodium - Generic Drug Details

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

Sugammadex sodium is the generic ingredient in one branded drug marketed by Organon Sub Merck and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sugammadex sodium has fifty-six patent family members in thirty countries.

There are two drug master file entries for sugammadex sodium. One supplier is listed for this compound.

Summary for sugammadex sodium

International Patents:	56
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	12
Clinical Trials:	6
Formulation / Manufacturing:	see details
DailyMed Link:	sugammadex sodium at DailyMed

Recent Clinical Trials for sugammadex sodium

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

Sponsor	Phase
Ministry of Food and Drug Safety, Korea	Phase 2
Seoul National University Hospital	Phase 2
Merck Canada Inc.	Phase 4

See all sugammadex sodium clinical trials

Pharmacology for sugammadex sodium

Synonyms for sugammadex sodium

1202253-72-2

343306-71-8

343306-79-6

361LPM2T56

862667-16-1

AC-30384

Bridion

Bridion (TN)

CHEBI:90952

CHEBI:90953

D05940

DB06206

ERJ6X2MXV7

EX-A2600

gamma-Cyclodextrin, 6A,6B,6C,6D,6E,7F,6G,6H-octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,7F,6G,6H-octathio-, octasodium salt

MK-8616

Octasodium 6,6',6'',6''',6'''',6''''',6'''''',6'''''''-octakis-S-(2-carboxylatoethyl)-6,6',6'',6''',6'''',6''''',6'''''',6'''''''-octathiocyclo-alpha-(1-4)-D-octaglucopyranoside

Org 25969

ORG-25969

SCH-900616

SCHEMBL13917069

Sugammadex

Sugammadex [USAN:INN:BAN]

Sugammadex sodium (JAN/USAN)

Sugammadex sodium [USAN:JAN]

UNII-361LPM2T56

UNII-ERJ6X2MXV7

US Patents and Regulatory Information for sugammadex sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015		RX	Yes	No			Y	Y
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015		RX	Yes	Yes			Y	Y
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015		RX	Yes	No
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015		RX	Yes	No
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015		RX	Yes	Yes
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015		RX	Yes	No
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015		RX	Yes	Yes

International Patents for sugammadex sodium

Country	Patent Number	Estimated Expiration
European Patent Office	1259550
Japan	2006348301
Czech Republic	20021814
Hong Kong	1049489
Australia	7508900
Brazil	0013126
China	1188428

Supplementary Protection Certificates for sugammadex sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	2008C/047	Belgium		PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550	47/2008	Austria		PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	91501	Luxembourg		91501, EXPIRES: 20230725
1259550	SPC/GB08/057	United Kingdom		PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
1259550	SPC031/2008	Ireland		SPC031/2008: 20090428, EXPIRES: 20230724
1259550	SZ 47/2008	Austria		PRODUCT NAME: SUGAMMADEX; 6-PER-DEOXY-6-PER-(2-CARBOXYETHYL) THIO-Y-CYCLODEXTRIN UND PHARMAZEUTISCH VERTRÄGLICHES SALZ HIERVON
1259550	CA 2009 00002	Denmark		PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM