Is there a generic for Mirdametinib?

The FDA Orange Book does not currently list an approved generic (ANDA) for Mirdametinib. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Mirdametinib?

GOMEKLI (NDA 219389, SPRINGWORKS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Mirdametinib?

The Orange Book lists 22 patents against Mirdametinib products, with the earliest listed expiry in 2041. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Mirdametinib have FDA marketing exclusivity?

Yes. The Orange Book records 6 marketing-exclusivity periods for Mirdametinib. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Mirdametinib are approved?

Mirdametinib is approved in the following dosage forms: capsule, tablet, for suspension.

FDA Orange Book · active-ingredient family

Mirdametinib

Mirdametinib: 2 brands, 0 generics; first approved Feb 11, 2025; on patent until Feb 17, 2041.

On patent6 exclusivity periods

Generic status & protection

Protected until Feb 17, 2041 (earliest listed patent expiry).

Earliest patent expiry Feb 17, 2041Latest exclusivity ends Feb 11, 2032

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 17, 2041

in 14 yr 10 mo

Originator applications

Brand (NDA) products

GOMEKLIRLD

SPRINGWORKSNDA 21938920252 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	CAPSULE	ORAL	Rx	—
2MG	CAPSULE	ORAL	Rx	—

GOMEKLIRLDRS

SPRINGWORKSNDA 2193792025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET, FOR SUSPENSION	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

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 8 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 8 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 8 mo

Orange Book patent file

Listed patents

Listed patents (22)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12295925	Feb 17, 2041	in 14 yr 10 mo	U-4130
12011424	Feb 17, 2041	in 14 yr 10 mo	U-4130
11819487	Feb 17, 2041	in 14 yr 10 mo	U-4130
11806321	Feb 17, 2041	in 14 yr 10 mo	U-4130
11453641	Feb 17, 2041	in 14 yr 10 mo	U-4130
12263146	Feb 17, 2041	in 14 yr 10 mo	U-4130
12275688	Feb 17, 2041	in 14 yr 10 mo	ProductU-4130
12037306	Feb 17, 2041	in 14 yr 10 mo	U-4130
11066358	Feb 17, 2041	in 14 yr 10 mo	Substance
11084780	Feb 17, 2041	in 14 yr 10 mo	Substance
12357597	Feb 17, 2041	in 14 yr 10 mo	U-4130
12090128	Feb 17, 2041	in 14 yr 10 mo	ProductU-4130
11571402	Feb 17, 2041	in 14 yr 10 mo	Product
11883375	Mar 16, 2043	in 16 yr 11 mo	U-4130
12324791	Mar 16, 2043	in 16 yr 11 mo	U-4130
11839595	Mar 16, 2043	in 16 yr 11 mo	U-4130
12257215	Mar 16, 2043	in 16 yr 11 mo	U-4130
12220390	Mar 16, 2043	in 16 yr 11 mo	U-4130
11806322	Apr 09, 2043	in 17 yr	U-4130
12383517	Mar 15, 2044	in 17 yr 11 mo	ProductU-4130
12029711	Mar 15, 2044	in 17 yr 11 mo	ProductU-4130
12390430	Oct 10, 2044	in 18 yr 6 mo	U-4130

FDA approval span

Approval history

First approval

Feb 11, 2025

1 yr 5 mo ago

Most recent approval

Feb 11, 2025

1 yr 5 mo ago

All 2 applications were approved in 2025.

Brand (NDA) 2100%

Generic (ANDA) 00%

Mirdametinib — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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