Assyro AI

Orange Book product · Brand (NDA)

LENVIMA

LENVATINIB MESYLATE

Brand (NDA)NDA 206947RX EISAI INC

At a glance

Feb 13, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

21

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 13, 2015

    11 yr 6 mo ago

  2. Exclusivity ends · ODE-196

    Orphan-drug exclusivity (7 years)

    Aug 15, 2025

    10 mo ago

  3. Patent 7253286 expires

    Listed drug substance patent expiration.

    Oct 24, 2025

    8 mo ago

  4. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Feb 15, 2026

    4 mo ago

  5. Patent 7253286*PED expires

    Listed listed patent expiration.

    Apr 24, 2026

    2 mo ago

  6. Today

  7. Patent 7612208 expires

    Listed drug substance patent expiration.

    Sep 19, 2026

    in 3 mo

  8. Patent 7612208*PED expires

    Listed listed patent expiration.

    Mar 19, 2027

    in 9 mo

  9. Exclusivity ends · M-14

    New use / labeling-change exclusivity (3 years)

    Apr 03, 2027

    in 10 mo

  10. Patent 9006256 expires

    Listed method-of-use patent (U-1695) expiration.

    Jul 27, 2027

    in 1 yr 1 mo

  11. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Oct 03, 2027

    in 1 yr 4 mo

  12. Patent 9006256*PED expires

    Listed listed patent expiration.

    Jan 27, 2028

    in 1 yr 8 mo

  13. Patent 12508313 expires

    Listed drug product patent expiration.

    Oct 04, 2030

    in 4 yr 4 mo

  14. Patent 12508313*PED expires

    Listed listed patent expiration.

    Apr 04, 2031

    in 4 yr 10 mo

  15. Patent 10259791 expires

    Listed drug substance patent expiration.

    Aug 26, 2035

    in 9 yr 4 mo

  16. Patent 10407393 expires

    Listed drug substance patent expiration.

    Aug 26, 2035

    in 9 yr 4 mo

  17. Patent 11186547 expires

    Listed drug substance patent expiration.

    Aug 26, 2035

    in 9 yr 4 mo

  18. Patent 11090386 expires

    Listed method-of-use patent (U-3519) expiration.

    Feb 23, 2036

    in 9 yr 10 mo

  19. Patent 10259791*PED expires

    Listed listed patent expiration.

    Feb 26, 2036

    in 9 yr 10 mo

  20. Patent 10407393*PED expires

    Listed listed patent expiration.

    Feb 26, 2036

    in 9 yr 10 mo

  21. Patent 11186547*PED expires

    Listed listed patent expiration.

    Feb 26, 2036

    in 9 yr 10 mo

  22. Patent 12083112 expires

    Listed method-of-use patent (U-3996) expiration.

    Mar 03, 2036

    in 9 yr 10 mo

  23. Patent 12083112 expires

    Listed method-of-use patent (U-3997) expiration.

    Mar 03, 2036

    in 9 yr 10 mo

  24. Patent 11090386*PED expires

    Listed listed patent expiration.

    Aug 23, 2036

    in 10 yr 4 mo

  25. Patent 12083112*PED expires

    Listed listed patent expiration.

    Sep 03, 2036

    in 10 yr 4 mo

  26. Patent 12226409 expires

    Listed method-of-use patent (U-4146) expiration.

    May 15, 2038

    in 12 yr 1 mo

  27. Patent 12226409*PED expires

    Listed listed patent expiration.

    Nov 15, 2038

    in 12 yr 7 mo

Pharmaceutical detail

Active ingredient

LENVATINIB MESYLATE

Strength

EQ 10MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 206947

Product number

002

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 (4)

  • ODE-196Orphan-drug exclusivity (7 years)

    Aug 15, 2025

    10 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Feb 15, 2026

    4 mo ago

  • M-14New use / labeling-change exclusivity (3 years)

    Apr 03, 2027

    in 10 mo

  • PEDPediatric exclusivity (adds 6 months)

    Oct 03, 2027

    in 1 yr 4 mo

Listed patents (21)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7253286Oct 24, 20258 mo ago
SubstanceProduct
7253286*PEDApr 24, 20262 mo ago
7612208Sep 19, 2026in 3 mo
SubstanceProduct
7612208*PEDMar 19, 2027in 9 mo
9006256Jul 27, 2027in 1 yr 1 mo
U-1695
9006256*PEDJan 27, 2028in 1 yr 8 mo
12508313Oct 04, 2030in 4 yr 4 mo
Product
12508313*PEDApr 04, 2031in 4 yr 10 mo
10259791Aug 26, 2035in 9 yr 4 mo
Substance
10407393Aug 26, 2035in 9 yr 4 mo
Substance
11186547Aug 26, 2035in 9 yr 4 mo
Substance
11090386Feb 23, 2036in 9 yr 10 mo
U-3519
10259791*PEDFeb 26, 2036in 9 yr 10 mo
10407393*PEDFeb 26, 2036in 9 yr 10 mo
11186547*PEDFeb 26, 2036in 9 yr 10 mo
12083112Mar 03, 2036in 9 yr 10 mo
U-3996
12083112Mar 03, 2036in 9 yr 10 mo
U-3997
11090386*PEDAug 23, 2036in 10 yr 4 mo
12083112*PEDSep 03, 2036in 10 yr 4 mo
12226409May 15, 2038in 12 yr 1 mo
U-4146
12226409*PEDNov 15, 2038in 12 yr 7 mo
Agent CTA Background

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