Is there a generic for Fosphenytoin sodium?

Yes. The FDA Orange Book lists 14 approved generic (ANDA) applications for Fosphenytoin sodium, referencing the brand SESQUIENT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fosphenytoin sodium?

SESQUIENT (NDA 210864, LUPIN) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Fosphenytoin sodium?

The Orange Book lists 5 patents against Fosphenytoin sodium products, with the earliest listed expiry in 2029. 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.

What dosage forms of Fosphenytoin sodium are approved?

Fosphenytoin sodium is approved in the following dosage forms: injectable, solution.

FDA Orange Book · active-ingredient family

Fosphenytoin sodium

Fosphenytoin sodium: 2 brands, 14 generics; first approved Aug 05, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 14 ANDA applications approved.

Earliest patent expiry Mar 13, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 13, 2029

in 2 yr 5 mo

Brand (NDA) products

Originator applications

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SESQUIENTRLD

LUPINNDA 21086420202 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML)	SOLUTION	INTRAVENOUS	Discontinued	-
EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML)	SOLUTION	INTRAVENOUS	Discontinued	-

CEREBYXRLDRS
PARKE DAVISNDA 0204501996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Rx	AP

Generic (ANDA) products (14)

Abbreviated applications

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FOSPHENYTOIN SODIUM
GLANDANDA 2149262023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Rx AP
FOSPHENYTOIN SODIUM
PHARMOBEDIENTANDA 0787362010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Discontinued -
FOSPHENYTOIN SODIUM
AM REGENTANDA 0900992010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Discontinued -
FOSPHENYTOIN SODIUM
HIKMA FARMACEUTICAANDA 0787652009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Rx AP
FOSPHENYTOIN SODIUM
AMNEALANDA 0784762008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Discontinued -
FOSPHENYTOIN SODIUM
SUN PHARMANDA 0784172008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Rx AP
FOSPHENYTOIN SODIUM
AM REGENTANDA 0782772007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Discontinued -
FOSPHENYTOIN SODIUM
APOTEX INCANDA 0781262007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Discontinued -
FOSPHENYTOIN SODIUM
DR REDDYSANDA 0768862007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Discontinued -
FOSPHENYTOIN SODIUM
FRESENIUS KABI USAANDA 0780522007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Rx AP
FOSPHENYTOIN SODIUM
HIKMAANDA 0774812007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Rx AP
FOSPHENYTOIN SODIUM
HIKMAANDA 0779892007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Rx AP
FOSPHENYTOIN SODIUM
HOSPIRAANDA 0781582007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Discontinued -
FOSPHENYTOIN SODIUM
WOCKHARDT BIO AGANDA 0781372007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG PHENYTOIN NA/ML INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG PHENYTOIN NA/ML	INJECTABLE	INJECTION	Rx	AP

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8410077	Mar 13, 2029	in 2 yr 5 mo	Product
9200088	Mar 13, 2029	in 2 yr 5 mo	Product
9750822	Mar 13, 2029	in 2 yr 5 mo	Product
7635773	Mar 13, 2029	in 2 yr 5 mo	Product
9493582	Feb 27, 2033	in 6 yr 5 mo	Product

Approval history

FDA approval span

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First approval

Aug 05, 1996

30 yr 8 mo ago

Most recent approval

Oct 13, 2023

3 yr 1 mo ago

Approvals span 1996–2023 across 16 FDA applications.

Brand (NDA) 213%

Generic (ANDA) 1488%

Fosphenytoin 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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