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FDA Orange Book · active-ingredient family

Enzalutamide

Enzalutamide is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:XTANDI · NDA 213674

2

Brand (NDA)

4

Generics (ANDA)

7

Listed patents

3

Exclusivity periods

Brand (NDA) products · capsule, tablet

ProductApplicantApplicationTEApproved
XTANDIRLD×2ASTELLASNDA 213674ABAug 04, 2020
XTANDIRLDASTELLASNDA 203415—Aug 31, 2012

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
ENZALUTAMIDE×2SANDOZANDA 216068ABApr 20, 2026
ENZALUTAMIDEZYDUS PHARMSANDA 209667—Sep 26, 2024
ENZALUTAMIDEAPOTEXANDA 209645—Apr 22, 2022
ENZALUTAMIDEACTAVIS LABS FL INCANDA 209614—May 14, 2021

Marketing exclusivity (3)

  • I-926New indication exclusivity (3 years)

    Nov 17, 2026

    in 5 mo

  • I-926New indication exclusivity (3 years)

    Nov 17, 2026

    in 5 mo

  • I-926New indication exclusivity (3 years)

    Nov 17, 2026

    in 5 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9126941May 15, 20261 mo ago
U-2345
8183274Aug 24, 2026in 2 mo
U-1281
7709517Aug 13, 2027in 1 yr 2 mo
SubstanceProduct
12502357Sep 11, 2033in 7 yr 4 mo
U-4363
11839689Sep 11, 2033in 7 yr 4 mo
Product
12447128Sep 11, 2033in 7 yr 4 mo
U-4312
12161628Feb 23, 2037in 10 yr 10 mo
U-4101

Enzalutamide — frequently asked questions

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

Agent CTA Background

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