Is there a generic for Methsuximide?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Methsuximide, referencing the brand CELONTIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Methsuximide?

CELONTIN (NDA 010596, PARKE DAVIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Methsuximide are approved?

Methsuximide is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Methsuximide

Methsuximide is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CELONTIN · NDA 010596

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
CELONTINRLD×2	PARKE DAVIS	NDA 010596	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
METHSUXIMIDE	NOVITIUM PHARMA	ANDA 217213	AB	May 01, 2023

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Methsuximide — frequently asked questions

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

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