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 two branded drugs marketed by Msd Sub Merck, Aspiro, and Zydus Pharms, and is included in three NDAs. 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. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for SUGAMMADEX SODIUM

International Patents:	42
US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	10
Patent Applications:	89
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
Korea University Ansan Hospital	Phase 4
YingHsuanTai	N/A
Zhejiang Cancer Hospital	N/A

See all SUGAMMADEX SODIUM clinical trials

Generic filers with tentative approvals for SUGAMMADEX SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	200MG/2ML(100MG/ML)	INJECTABLE;INJECTION
⤷ Sign Up	⤷ Sign Up	500MG/5ML(100MG/ML)	INJECTABLE;INJECTION

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	BRIDION	sugammadex sodium	SOLUTION;INTRAVENOUS	022225-002	Dec 15, 2015	AP	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Aspiro	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214337-002	Jun 9, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214290-001	Oct 4, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aspiro	SUGAMMADEX SODIUM	sugammadex sodium	SOLUTION;INTRAVENOUS	214337-001	Jun 9, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for SUGAMMADEX SODIUM

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

International Patents for SUGAMMADEX SODIUM

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Country	Patent Number	Title	Estimated Expiration
New Zealand	518752	6-mercapto-cyclodextrin derivatives that are useful as reversal agents for drug-induced neuromuscular block	⤷ Sign Up
Peru	09022001		⤷ Sign Up
Luxembourg	91501		⤷ Sign Up
Spain	2237496		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SUGAMMADEX SODIUM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	91501	Luxembourg	⤷ Sign Up	91501, EXPIRES: 20230725
1259550	340	Finland	⤷ Sign Up
1259550	47/2008	Austria	⤷ Sign Up	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	SPC/GB08/057	United Kingdom	⤷ Sign Up	PRODUCT NAME: SUGAMMADEX; REGISTERED: UK EU/1/08/466/001 20080725; UK EU/1/08/466/002 20080725
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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