Assyro AI

Orange Book product · Brand (NDA)

SPRAVATO

ESKETAMINE HYDROCHLORIDE

Brand (NDA)NDA 211243RX JANSSEN PHARMS
View ESKETAMINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Mar 05, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

25

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 05, 2019

    7 yr 5 mo ago

  2. Today

  3. Patent 9592207 expires

    Listed method-of-use patent (U-2502) expiration.

    Mar 20, 2027

    in 9 mo

  4. Patent 9592207 expires

    Listed method-of-use patent (U-4112) expiration.

    Mar 20, 2027

    in 9 mo

  5. Exclusivity ends · I-959

    New indication exclusivity (3 years)

    Jan 17, 2028

    in 1 yr 7 mo

  6. Patent 8785500 expires

    Listed method-of-use patent (U-2502) expiration.

    Mar 05, 2033

    in 6 yr 10 mo

  7. Patent 8785500 expires

    Listed method-of-use patent (U-4112) expiration.

    Mar 05, 2033

    in 6 yr 10 mo

  8. Patent 11446260 expires

    Listed method-of-use patent (U-4118) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  9. Patent 11446260 expires

    Listed method-of-use patent (U-4119) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  10. Patent 11446260 expires

    Listed method-of-use patent (U-3444) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  11. Patent 11446260 expires

    Listed method-of-use patent (U-3445) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  12. Patent 11446260 expires

    Listed method-of-use patent (U-3446) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

  13. Patent 10869844 expires

    Listed method-of-use patent (U-4113) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  14. Patent 10869844 expires

    Listed method-of-use patent (U-4114) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  15. Patent 10869844 expires

    Listed method-of-use patent (U-3035) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  16. Patent 10869844 expires

    Listed method-of-use patent (U-3034) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  17. Patent 10869844 expires

    Listed method-of-use patent (U-3036) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  18. Patent 11173134 expires

    Listed method-of-use patent (U-4115) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  19. Patent 11173134 expires

    Listed method-of-use patent (U-3536) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  20. Patent 11173134 expires

    Listed method-of-use patent (U-3257) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  21. Patent 11311500 expires

    Listed method-of-use patent (U-4116) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  22. Patent 11311500 expires

    Listed method-of-use patent (U-4117) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  23. Patent 11311500 expires

    Listed method-of-use patent (U-3034) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  24. Patent 11311500 expires

    Listed method-of-use patent (U-3036) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  25. Patent 11311500 expires

    Listed method-of-use patent (U-3035) expiration.

    Sep 10, 2035

    in 9 yr 4 mo

  26. Patent 11883526 expires

    Listed method-of-use patent (U-4120) expiration.

    Feb 18, 2040

    in 13 yr 10 mo

  27. Patent 11883526 expires

    Listed method-of-use patent (U-3812) expiration.

    Feb 18, 2040

    in 13 yr 10 mo

  28. Patent 11883526 expires

    Listed method-of-use patent (U-3813) expiration.

    Feb 18, 2040

    in 13 yr 10 mo

Pharmaceutical detail

Active ingredient

ESKETAMINE HYDROCHLORIDE

Strength

EQ 28MG BASE

Dosage form

SPRAY

Route

NASAL

TE code

Not listed

Application

NDA 211243

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • I-959New indication exclusivity (3 years)

    Jan 17, 2028

    in 1 yr 7 mo

Listed patents (25)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9592207Mar 20, 2027in 9 mo
U-2502
9592207Mar 20, 2027in 9 mo
U-4112
8785500Mar 05, 2033in 6 yr 10 mo
U-2502
8785500Mar 05, 2033in 6 yr 10 mo
U-4112
11446260Mar 14, 2034in 7 yr 10 mo
U-4118
11446260Mar 14, 2034in 7 yr 10 mo
U-4119
11446260Mar 14, 2034in 7 yr 10 mo
U-3444
11446260Mar 14, 2034in 7 yr 10 mo
U-3445
11446260Mar 14, 2034in 7 yr 10 mo
U-3446
10869844Sep 10, 2035in 9 yr 4 mo
U-4113
10869844Sep 10, 2035in 9 yr 4 mo
U-4114
10869844Sep 10, 2035in 9 yr 4 mo
U-3035
10869844Sep 10, 2035in 9 yr 4 mo
U-3034
10869844Sep 10, 2035in 9 yr 4 mo
U-3036
11173134Sep 10, 2035in 9 yr 4 mo
U-4115
11173134Sep 10, 2035in 9 yr 4 mo
U-3536
11173134Sep 10, 2035in 9 yr 4 mo
U-3257
11311500Sep 10, 2035in 9 yr 4 mo
U-4116
11311500Sep 10, 2035in 9 yr 4 mo
U-4117
11311500Sep 10, 2035in 9 yr 4 mo
U-3034
11311500Sep 10, 2035in 9 yr 4 mo
U-3036
11311500Sep 10, 2035in 9 yr 4 mo
U-3035
11883526Feb 18, 2040in 13 yr 10 mo
U-4120
11883526Feb 18, 2040in 13 yr 10 mo
U-3812
11883526Feb 18, 2040in 13 yr 10 mo
U-3813
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