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FDA Orange Book · active-ingredient family

Mirdametinib

Mirdametinib is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:GOMEKLI · NDA 219389

2

Brand (NDA)

0

Generics (ANDA)

22

Listed patents

6

Exclusivity periods

Brand (NDA) products · capsule, tablet, for suspension

ProductApplicantApplicationTEApproved
GOMEKLIRLD×2SPRINGWORKSNDA 219389—Feb 11, 2025
GOMEKLIRLDSPRINGWORKSNDA 219379—Feb 11, 2025

Marketing exclusivity (6)

  • NCENew chemical entity exclusivity (5 years)

    Feb 11, 2030

    in 3 yr 8 mo

  • ODE-488Orphan-drug exclusivity (7 years)

    Feb 11, 2032

    in 5 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Feb 11, 2030

    in 3 yr 8 mo

  • ODE-488Orphan-drug exclusivity (7 years)

    Feb 11, 2032

    in 5 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Feb 11, 2030

    in 3 yr 8 mo

  • ODE-488Orphan-drug exclusivity (7 years)

    Feb 11, 2032

    in 5 yr 9 mo

Listed patents (22)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12295925Feb 17, 2041in 14 yr 11 mo
U-4130
12011424Feb 17, 2041in 14 yr 11 mo
U-4130
11819487Feb 17, 2041in 14 yr 11 mo
U-4130
11806321Feb 17, 2041in 14 yr 11 mo
U-4130
11453641Feb 17, 2041in 14 yr 11 mo
U-4130
12263146Feb 17, 2041in 14 yr 11 mo
U-4130
12275688Feb 17, 2041in 14 yr 11 mo
ProductU-4130
12037306Feb 17, 2041in 14 yr 11 mo
U-4130
11066358Feb 17, 2041in 14 yr 11 mo
Substance
11084780Feb 17, 2041in 14 yr 11 mo
Substance
12357597Feb 17, 2041in 14 yr 11 mo
U-4130
12090128Feb 17, 2041in 14 yr 11 mo
ProductU-4130
11571402Feb 17, 2041in 14 yr 11 mo
Product
11883375Mar 16, 2043in 17 yr
U-4130
12324791Mar 16, 2043in 17 yr
U-4130
11839595Mar 16, 2043in 17 yr
U-4130
12257215Mar 16, 2043in 17 yr
U-4130
12220390Mar 16, 2043in 17 yr
U-4130
11806322Apr 09, 2043in 17 yr 1 mo
U-4130
12383517Mar 15, 2044in 18 yr
ProductU-4130
12029711Mar 15, 2044in 18 yr
ProductU-4130
12390430Oct 10, 2044in 18 yr 7 mo
U-4130

Mirdametinib — 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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