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FDA Orange Book · active-ingredient family

Esketamine hydrochloride

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

Reference-listed drug:SPRAVATO · NDA 211243

1

Brand (NDA)

0

Generics (ANDA)

7

Listed patents

1

Exclusivity periods

Brand (NDA) products · spray

ProductApplicantApplicationTEApproved
SPRAVATORLDJANSSEN PHARMSNDA 211243—Mar 05, 2019

Marketing exclusivity (1)

  • I-959New indication exclusivity (3 years)

    Jan 17, 2028

    in 1 yr 7 mo

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9592207Mar 20, 2027in 9 mo
U-2502
8785500Mar 05, 2033in 6 yr 10 mo
U-2502
11446260Mar 14, 2034in 7 yr 10 mo
U-4118
10869844Sep 10, 2035in 9 yr 4 mo
U-4113
11173134Sep 10, 2035in 9 yr 4 mo
U-4115
11311500Sep 10, 2035in 9 yr 4 mo
U-4116
11883526Feb 18, 2040in 13 yr 10 mo
U-4120

Esketamine hydrochloride — 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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