Is There a Generic for Zurzuvae?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Zurzuvae (zuranolone). The Orange Book shows its last listed patent expires August 23, 2037 and its last listed exclusivity ends October 31, 2028.

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Zurzuvae products in the Orange Book

Zurzuvae products and approved generics
Form and route	Strength	Brand status	Brand TE	Generic TE codes
capsule, oral	20MG	Marketed (Rx)	None	None
capsule, oral	25MG	Marketed (Rx)	None	None
capsule, oral	30MG	Marketed (Rx)	None	None

NDA 217369, held by BIOGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Zurzuvae patents

Patents listed for Zurzuvae
Patent	Expires	Covers	Use code	NDA
10342810	April 17, 2034	Method of use	U-2552	217369
10172871	April 17, 2034	Method of use	U-2552	217369
9512165	April 17, 2034	Drug substance, Drug product	None	217369
11884696	August 23, 2037	Method of use	U-2552	217369
11236121	August 23, 2037	Drug substance	None	217369

Zurzuvae exclusivity

Exclusivity listed for Zurzuvae
Code	Meaning	Expires	NDA
NCE	New chemical entity	October 31, 2028	217369

Zurzuvae NDC codes

Questions

Is there a generic for Zurzuvae?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Zurzuvae (zuranolone). The Orange Book shows its last listed patent expires August 23, 2037 and its last listed exclusivity ends October 31, 2028.

What is the generic name for Zurzuvae?

The active ingredient in Zurzuvae is zuranolone, per the FDA Orange Book.

When does the Zurzuvae patent expire?

The last patent listed for Zurzuvae in the Orange Book expires August 23, 2037. 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.