Is there a generic for Sugammadex sodium?

Yes. The FDA Orange Book lists 19 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.

What is the reference-listed drug for Sugammadex sodium?

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.

What patents protect Sugammadex sodium?

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.

Does Sugammadex sodium have FDA marketing exclusivity?

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.

What dosage forms of Sugammadex sodium are approved?

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

FDA Orange Book · active-ingredient family

Sugammadex sodium

Sugammadex sodium: 1 brand, 19 generics; first approved Dec 15, 2015; generic available.

Generic available4 exclusivity periods

Generic status & protection

Generic available: 19 ANDA applications approved.

Earliest patent expiry Jan 27, 2026Latest exclusivity ends Jun 12, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 27, 2026

8 mo ago

Brand (NDA) products

Originator applications

BRIDIONRLDRS
MSD SUB MERCKNDA 02222520152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Generic (ANDA) products (19)

Abbreviated applications

SUGAMMADEX SODIUM
DR REDDYSANDA 21423620262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
FRESENIUS KABI USAANDA 2194482026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
GLANDANDA 21436420262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
HIKMAANDA 2187272026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
HIKMAANDA 21872820262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
LUPINANDA 21433820262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
MANKIND PHARMAANDA 21423020262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
MSNANDA 21436820262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
MYLANANDA 21391520262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
QILU PHARM HAINANANDA 21557520262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
SANDOZANDA 21431120262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
STERISCIENCEANDA 21881420262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
SUN PHARM INDS INCANDA 21431920262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
TAMARANGANDA 21526020262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
TEVA PHARMS USA INCANDA 21412620262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
ZENARAANDA 21430620262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
B BRAUN MEDICALANDA 2142792025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
ZYDUS PHARMSANDA 21429020232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
SUGAMMADEX SODIUM
ASPIROANDA 21433720232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) SOLUTION INTRAVENOUS Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPPNew patient population exclusivity (3 years)
Dec 12, 2027
in 1 yr 3 mo
PEDPediatric exclusivity (adds 6 months)
Jun 12, 2028
in 1 yr 9 mo
NPPNew patient population exclusivity (3 years)
Dec 12, 2027
in 1 yr 3 mo
PEDPediatric exclusivity (adds 6 months)
Jun 12, 2028
in 1 yr 9 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
RE44733	Jan 27, 2026	8 mo ago	SubstanceProductU-1794
RE44733*PED	Jul 27, 2026	2 mo ago

Approval history

FDA approval span

First approval

Dec 15, 2015

10 yr 11 mo ago

Most recent approval

Jul 28, 2026

2 mo ago

Approvals span 2015–2026 across 20 FDA applications.

Brand (NDA) 15%

Generic (ANDA) 1995%

Sugammadex sodium: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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