Sugammadex sodium - Generic Drug Details

What are the generic 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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Sugammadex sodium has forty-two patent family members in thirty countries.

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

Summary for sugammadex sodium

International Patents:	42
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	9
Patent Applications:	140
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sugammadex sodium
DailyMed Link:	sugammadex sodium at DailyMed

Recent Clinical Trials for sugammadex sodium

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

Sponsor	Phase
YingHsuanTai	N/A
Zhejiang Cancer Hospital	N/A
Ministry of Food and Drug Safety, Korea	Phase 2

See all sugammadex sodium clinical trials

Generic filers with tentative approvals for SUGAMMADEX SODIUM

Applicant	Application No.	Strength	Dosage Form
		EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION;INTRAVENOUS

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 sugammadex sodium

Paragraph IV (Patent) Challenges for SUGAMMADEX SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRIDION	Injection	sugammadex sodium	200 mg/2 mL and 500 mg/5 mL	022225	14	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
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	022225-001	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
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015		RX	Yes	No			Y	Y

Expired US Patents for sugammadex sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015

International Patents for sugammadex sodium

Country	Patent Number	Title	Estimated Expiration
Japan	2003515623
Canada	2390463	DERIVES DE 6-MERCAPTO-CYCLODEXTRINE: AGENTS D'INVERSION DU BLOCAGE NEUROMUSCULAIRE PROVOQUE PAR DES SUBSTANCES MEDICAMENTEUSES (6-MERCAPTO-CYCLODEXTRIN DERIVATIVES: REVERSAL AGENTS FOR DRUG-INDUCED NEUROMUSCULAR BLOCK)
Netherlands	300356
Poland	203012
China	1188428
Germany	60017947

Supplementary Protection Certificates for sugammadex sodium

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