Question 1

Is there a generic for Sugammadex sodium?

Accepted Answer

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Sugammadex sodium, referencing the brand BRIDION. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Sugammadex sodium?

Accepted Answer

BRIDION (NDA 022225, MSD SUB MERCK) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sugammadex sodium?

Accepted Answer

The Orange Book lists 2 patents against Sugammadex sodium products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Sugammadex sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Sugammadex sodium. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Sugammadex sodium are approved?

Accepted Answer

Sugammadex sodium is approved in the following dosage form: solution.

Product	Applicant	Application	TE	Approved
SUGAMMADEX SODIUM	B BRAUN MEDICAL	ANDA 214279	AP	Aug 05, 2025
SUGAMMADEX SODIUM×2	ZYDUS PHARMS	ANDA 214290	AP	Oct 04, 2023
SUGAMMADEX SODIUM×2	ASPIRO	ANDA 214337	AP	Jun 09, 2023

Patent	Expires	In	Type
RE44733	Jan 27, 2026	5 mo ago	SubstanceProductU-1794
RE44733*PED	Jul 27, 2026	in 1 mo

Sugammadex sodium

Brand (NDA) products · solution

Generic (ANDA) products (3)

Marketing exclusivity (4)

Listed patents (2)

Sugammadex sodium — frequently asked questions

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