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BRIDION Drug Profile

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Which patents cover Bridion, and when can generic versions of Bridion launch?

Bridion is a drug marketed by Organon Sub Merck and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-six patent family members in thirty countries.

The generic ingredient in BRIDION is sugammadex sodium. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sugammadex sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Bridion

Bridion will be eligible for patent challenges on December 15^th, 2019. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 27^th, 2021. This may change due to patent challenges or generic licensing.

Summary for BRIDION

International Patents:	56
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	13
Clinical Trials:	46
Patent Applications:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BRIDION
DailyMed Link:	BRIDION at DailyMed

See drug prices for BRIDION

Generic Entry Opportunity Date for BRIDION

NDA:

022225

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BRIDION

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

Sponsor	Phase
University of South Florida	Phase 3
Guangzhou General Hospital of Guangzhou Military Command	Phase 4
Yonsei University	N/A

See all BRIDION clinical trials

Pharmacology for BRIDION

Synonyms for BRIDION

1202253-72-2

343306-71-8

343306-79-6

361LPM2T56

862667-16-1

AC-30384

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

Sugammadex sodium (JAN/USAN)

Sugammadex sodium [USAN:JAN]

UNII-361LPM2T56

UNII-ERJ6X2MXV7

US Patents and Regulatory Information for BRIDION

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
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
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			Y	Y
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015		RX	Yes	Yes

International Patents for BRIDION

Country	Patent Number	Estimated Expiration
Czech Republic	20021814
World Intellectual Property Organization (WIPO)	0112202
Denmark	1259550
Netherlands	300356
South Africa	200203538
Czech Republic	298206
Mexico	PA02004940

Supplementary Protection Certificates for BRIDION

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	300356	Netherlands
1259550	SPC031/2008	Ireland		SPC031/2008: 20090428, EXPIRES: 20230724
1259550	340	Finland
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	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	C01259550/01	Switzerland		FUSION; FORMER OWNER: ORGANON BIO SCIENCES NEDERLAND B.V., NL