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FDA Orange Book · active-ingredient family

Lenvatinib mesylate

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

Reference-listed drug:LENVIMA · NDA 206947

1

Brand (NDA)

0

Generics (ANDA)

20

Listed patents

8

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
LENVIMARLD×2EISAI INCNDA 206947—Feb 13, 2015

Marketing exclusivity (8)

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

    Apr 03, 2027

    in 10 mo

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

    Aug 15, 2025

    10 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Feb 15, 2026

    4 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Oct 03, 2027

    in 1 yr 4 mo

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

    Apr 03, 2027

    in 10 mo

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

    Aug 15, 2025

    10 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Feb 15, 2026

    4 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    Oct 03, 2027

    in 1 yr 4 mo

Listed patents (20)

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
11186547Aug 26, 2035in 9 yr 4 mo
Substance
10407393Aug 26, 2035in 9 yr 4 mo
Substance
10259791Aug 26, 2035in 9 yr 4 mo
Substance
11090386Feb 23, 2036in 9 yr 10 mo
U-3519
11186547*PEDFeb 26, 2036in 9 yr 10 mo
10407393*PEDFeb 26, 2036in 9 yr 10 mo
10259791*PEDFeb 26, 2036in 9 yr 10 mo
12083112Mar 03, 2036in 9 yr 10 mo
U-3996
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

Lenvatinib mesylate — 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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