Question 1

Is there a generic for Perampanel?

Accepted Answer

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Perampanel, referencing the brand FYCOMPA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Perampanel?

Accepted Answer

FYCOMPA (NDA 208277, CATALYST PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Perampanel?

Accepted Answer

The Orange Book lists 1 patent against Perampanel 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 Perampanel have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Perampanel. 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 Perampanel are approved?

Accepted Answer

Perampanel is approved in the following dosage forms: suspension, tablet.

Product	Applicant	Application	TE	Approved
FYCOMPARLD	CATALYST PHARMS	NDA 208277	AB	Apr 29, 2016
FYCOMPARLD×6	CATALYST PHARMS	NDA 202834	AB	Oct 22, 2012

Product	Applicant	Application	TE	Approved
PERAMPANEL×6	MSN	ANDA 218178	AB	Nov 25, 2025
PERAMPANEL×6	TARO	ANDA 209538	AB	Nov 25, 2025
PERAMPANEL	MSN	ANDA 218152	AB	Jul 11, 2025
PERAMPANEL×6	TEVA PHARMS USA INC	ANDA 209801	AB	May 23, 2025

Perampanel

Brand (NDA) products · suspension, tablet

Generic (ANDA) products (4)

Marketing exclusivity (1)

Listed patents (1)

Perampanel — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.