Sugammadex sodium - Generic Drug Details

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 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:	24
Clinical Trials:	8
Patent Applications:	126
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
Ministry of Food and Drug Safety, Korea	Phase 2
Seoul National University Hospital	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

Anatomical Therapeutic Chemical (ATC) Classes for sugammadex sodium

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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	022225-002	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			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	022225-001	Dec 15, 2015		RX	Yes	Yes

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	022225-002	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-001	Dec 15, 2015
Organon Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015

International Patents for sugammadex sodium

Country	Patent Number	Title	Estimated Expiration
Austria	288450
Mexico	PA02004940	DERIVADOS DE 6-MERCAPTO-CICLODEXTRIN: AGENTES DE REVERTIMIENTO PARA BLOQUEO NEUROMUSCULAR INDUCIDO POR FARMACOS. (6 MERCAPTO CYCLODEXTRIN DERIVATIVES: REVERSAL AGENTS FOR DRUG INDUCED NEUROMUSCULAR BLOCK.)
Czech Republic	20021814
Brazil	0015947
Norway	20022522

Supplementary Protection Certificates for sugammadex sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	CA 2009 00002	Denmark		PRODUCT NAME: SUGAMMADEX ELLER FARMACEUTISK AKTIVE SALTE ELLER ESTERE DERAF, HERUNDER SUGAMMADEXNATRIUM
1259550	2008C/047	Belgium		PRODUCT NAME: SUGAMMADEX SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/08/466001 20080729
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1259550	340	Finland
1259550	122008000068	Germany		PRODUCT NAME: SUGAMMADEX ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725