FDA Orange Book

Generic for Fycompa

Fycompa contains perampanel. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Fycompa is perampanel. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Fycompa products in the Orange Book

Fycompa products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
suspension, oral	0.5MG/ML	Marketed (Rx)	AB	2	AB
tablet, oral	10MG	Marketed (Rx)	AB	4	AB
tablet, oral	12MG	Marketed (Rx)	AB	4	AB
tablet, oral	2MG	Marketed (Rx)	AB	4	AB
tablet, oral	4MG	Marketed (Rx)	AB	4	AB
tablet, oral	6MG	Marketed (Rx)	AB	4	AB
tablet, oral	8MG	Marketed (Rx)	AB	4	AB

NDA 208277, 202834, held by CATALYST PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic perampanel

Approved generic versions of Fycompa
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA INC	209801	AB (A-rated, therapeutically equivalent)	May 23, 2025	10MG, 12MG, 2MG, 4MG, 6MG, 8MG
MSN LABORATORIES PRIVATE LTD	218152	AB (A-rated, therapeutically equivalent)	July 11, 2025	0.5MG/ML
MSN LABORATORIES PRIVATE LTD	218178	AB (A-rated, therapeutically equivalent)	November 25, 2025	10MG, 12MG, 2MG, 4MG, 6MG, 8MG
TARO PHARMACEUTICAL INDUSTRIES LTD	209538	AB (A-rated, therapeutically equivalent)	November 25, 2025	10MG, 12MG, 2MG, 4MG, 6MG, 8MG
TARO PHARMACEUTICAL INDUSTRIES LTD	219052	AB (A-rated, therapeutically equivalent)	June 15, 2026	0.5MG/ML
AUROBINDO PHARMA LTD	220492	AB (A-rated, therapeutically equivalent)	October 2, 2026	10MG, 12MG, 2MG, 4MG, 6MG, 8MG

Fycompa patents

Patents listed for Fycompa
Patent	Expires	Covers	Use code	NDA
8772497	July 1, 2026	Drug substance	None	208277

Fycompa NDC codes

Questions

Is there a generic for Fycompa?

Yes. The generic name for Fycompa is perampanel. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Fycompa?

The active ingredient in Fycompa is perampanel, per the FDA Orange Book.

When does the Fycompa patent expire?

The last patent listed for Fycompa in the Orange Book expires July 1, 2026. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.