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Last Updated: February 20, 2020

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Sugammadex sodium - Generic Drug Details

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What are the generic drug sources for sugammadex sodium and what is the scope of patent protection?

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. Two suppliers are listed for this compound.

Summary for sugammadex sodium
Recent Clinical Trials for sugammadex sodium

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

SponsorPhase
Seoul National University HospitalPhase 2
Ministry of Food and Drug Safety, KoreaPhase 2
University Health Network, TorontoPhase 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
Paragraph IV (Patent) Challenges for SUGAMMADEX SODIUM
Tradename Dosage Ingredient NDA Submissiondate
BRIDION SOLUTION;INTRAVENOUS sugammadex sodium 022225 2019-12-16

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

Supplementary Protection Certificates for sugammadex sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1259550 SPC/GB08/057 United Kingdom   Start Trial PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
1259550 C01259550/01 Switzerland   Start Trial FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL
1259550 2008C/047 Belgium   Start Trial PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550 08C0052 France   Start Trial PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550 CA 2009 00002 Denmark   Start Trial PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM
1259550 47/2008 Austria   Start Trial 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 SPC031/2008 Ireland   Start Trial SPC031/2008: 20090428, EXPIRES: 20230724
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Johnson and Johnson
McKesson
Moodys
Merck

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