Is there a generic for Cenobamate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Cenobamate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Cenobamate?

XCOPRI (NDA 212839, SK LIFE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Cenobamate?

The Orange Book lists 2 patents against Cenobamate products, with the earliest listed expiry in 2032. 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 Cenobamate are approved?

Cenobamate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Cenobamate

Cenobamate: 1 brand, 0 generics; first approved Mar 10, 2020; on patent until Oct 30, 2032.

On patent

Generic status & protection

Protected until Oct 30, 2032 (earliest listed patent expiry).

Earliest patent expiry Oct 30, 2032

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 30, 2032

in 6 yr 5 mo

Originator applications

Brand (NDA) products

XCOPRIRLDRS

SK LIFENDA 21283920206 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG	TABLET	ORAL	Rx	—
25MG	TABLET	ORAL	Rx	—
50MG	TABLET	ORAL	Rx	—
100MG	TABLET	ORAL	Rx	—
150MG	TABLET	ORAL	Rx	—
200MG	TABLET	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7598279	Oct 30, 2032	in 6 yr 5 mo	Substance
11654133	Jun 16, 2039	in 13 yr 1 mo	U-3610

FDA approval span

Approval history

First approval

Mar 10, 2020

6 yr 5 mo ago

Most recent approval

Mar 10, 2020

6 yr 5 mo ago

All 1 application were approved in 2020.

Brand (NDA) 1100%

Generic (ANDA) 00%

Cenobamate — 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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