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FDA Orange Book · active-ingredient family

Zuranolone

Zuranolone is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ZURZUVAE · NDA 217369

1

Brand (NDA)

0

Generics (ANDA)

5

Listed patents

3

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
ZURZUVAERLD×3BIOGENNDA 217369—Oct 31, 2023

Marketing exclusivity (3)

  • NCENew chemical entity exclusivity (5 years)

    Oct 31, 2028

    in 2 yr 5 mo

  • NCENew chemical entity exclusivity (5 years)

    Oct 31, 2028

    in 2 yr 5 mo

  • NCENew chemical entity exclusivity (5 years)

    Oct 31, 2028

    in 2 yr 5 mo

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10342810Apr 17, 2034in 7 yr 11 mo
U-2552
10172871Apr 17, 2034in 7 yr 11 mo
U-2552
9512165Apr 17, 2034in 7 yr 11 mo
SubstanceProduct
11884696Aug 23, 2037in 11 yr 4 mo
U-2552
11236121Aug 23, 2037in 11 yr 4 mo
Substance

Zuranolone — frequently asked questions

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

Agent CTA Background

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

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