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Orange Book drug · Brand (NDA)

Gomekli

Mirdametinib

RLDNDA 219379 Springworks
Approved
Feb 11, 2025
Strengths
1
Listed patents
20
Applications
2

What does the FDA Orange Book show for Gomekli?

Gomekli contains Mirdametinib and appears in 2 FDA Orange Book applications. NDA 219379 is the lead filing, with 1 presentation shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications
2; lead NDA 219379

Every filing shown uses the exact FDA product name; the lead filing supplies the detailed presentation view.

Lead application holder
Springworks Therapeutics Inc

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
1

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
20

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
2

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0011MGTABLET, FOR SUSPENSIONORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Springworks Therapeutics Inc

The Orange Book identifies this organization as the applicant responsible for NDA 219379.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

1 presentation listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

20 listed patent expirations and 2 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Oct 10, 2044. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 0 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 219379 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet, For Suspension · Oral

Mirdametinib

1 application
Product rows
1
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-219379

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Product detail

NDA 219379
RLDRS
Strength
1MG
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    1 yr 6 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    in 3 yr 7 mo

  4. Exclusivity ends · ODE-488

    Orphan-drug exclusivity (7 years)

    in 5 yr 8 mo

  5. Patent 11066358 expires

    Listed drug substance patent expiration.

    in 14 yr 9 mo

  6. Patent 11084780 expires

    Listed drug substance patent expiration.

    in 14 yr 9 mo

  7. Patent 11453641 expires

    Listed method-of-use patent (U-4130) expiration.

    in 14 yr 9 mo

  8. Patent 11571402 expires

    Listed drug product patent expiration.

    in 14 yr 9 mo

  9. Patent 11806321 expires

    Listed method-of-use patent (U-4130) expiration.

    in 14 yr 9 mo

  10. Patent 11819487 expires

    Listed method-of-use patent (U-4130) expiration.

    in 14 yr 9 mo

  11. Patent 12011424 expires

    Listed method-of-use patent (U-4130) expiration.

    in 14 yr 9 mo

  12. Patent 12037306 expires

    Listed method-of-use patent (U-4130) expiration.

    in 14 yr 9 mo

  13. Patent 12090128 expires

    Listed drug product patent expiration.

    in 14 yr 9 mo

  14. Patent 12263146 expires

    Listed method-of-use patent (U-4130) expiration.

    in 14 yr 9 mo

  15. Patent 12295925 expires

    Listed method-of-use patent (U-4130) expiration.

    in 14 yr 9 mo

  16. Patent 12357597 expires

    Listed method-of-use patent (U-4130) expiration.

    in 14 yr 9 mo

  17. Patent 11839595 expires

    Listed method-of-use patent (U-4130) expiration.

    in 16 yr 11 mo

  18. Patent 11883375 expires

    Listed method-of-use patent (U-4130) expiration.

    in 16 yr 11 mo

  19. Patent 12220390 expires

    Listed method-of-use patent (U-4130) expiration.

    in 16 yr 11 mo

  20. Patent 12257215 expires

    Listed method-of-use patent (U-4130) expiration.

    in 16 yr 11 mo

  21. Patent 12324791 expires

    Listed method-of-use patent (U-4130) expiration.

    in 16 yr 11 mo

  22. Patent 11806322 expires

    Listed method-of-use patent (U-4130) expiration.

    in 16 yr 11 mo

  23. Patent 12029711 expires

    Listed drug product patent expiration.

    in 17 yr 11 mo

  24. Patent 12390430 expires

    Listed method-of-use patent (U-4130) expiration.

    in 18 yr 6 mo

Patent & exclusivity timeline

Protection horizon
2026202820302032203420362038204020422044TodayExclusivity NCE: 2030-02-11Exclusivity NCEExclusivity ODE-488: 2032-02-11Exclusivity ODE-488Patent 11066358: 2041-02-17Patent 11066358Patent 11084780: 2041-02-17Patent 11084780Patent 11453641: 2041-02-17Patent 11453641Patent 11571402: 2041-02-17Patent 11571402Patent 11806321: 2041-02-17Patent 11806321Patent 11819487: 2041-02-17Patent 11819487Patent 12011424: 2041-02-17Patent 12011424Patent 12037306: 2041-02-17Patent 12037306Patent 12090128: 2041-02-17Patent 12090128Patent 12263146: 2041-02-17Patent 12263146Patent 12295925: 2041-02-17Patent 12295925Patent 12357597: 2041-02-17Patent 12357597Patent 11839595: 2043-03-16Patent 11839595Patent 11883375: 2043-03-16Patent 11883375Patent 12220390: 2043-03-16Patent 12220390Patent 12257215: 2043-03-16Patent 12257215Patent 12324791: 2043-03-16Patent 12324791Patent 11806322: 2043-04-09Patent 11806322Patent 12029711: 2044-03-15Patent 12029711Patent 12390430: 2044-10-10Patent 12390430
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

MIRDAMETINIB

Strength

1MG

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 219379

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Marketing exclusivity

Hatch-Waxman
  • NCENew chemical entity exclusivity (5 years)

    in 3 yr 7 mo

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

    in 5 yr 8 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11066358in 14 yr 9 mo
Substance
11084780in 14 yr 9 mo
Substance
11453641in 14 yr 9 mo
U-4130
11571402in 14 yr 9 mo
Product
11806321in 14 yr 9 mo
U-4130
11819487in 14 yr 9 mo
U-4130
12011424in 14 yr 9 mo
U-4130
12037306in 14 yr 9 mo
U-4130
12090128in 14 yr 9 mo
ProductU-4130
12263146in 14 yr 9 mo
U-4130
12295925in 14 yr 9 mo
U-4130
12357597in 14 yr 9 mo
U-4130
11839595in 16 yr 11 mo
U-4130
11883375in 16 yr 11 mo
U-4130
12220390in 16 yr 11 mo
U-4130
12257215in 16 yr 11 mo
U-4130
12324791in 16 yr 11 mo
U-4130
11806322in 16 yr 11 mo
U-4130
12029711in 17 yr 11 mo
ProductU-4130
12390430in 18 yr 6 mo
U-4130

Other FDA applications for Gomekli

1 additional filing

The FDA has approved 2 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Gomekli, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 219389SpringworksFeb 11, 20252—Prescription

Active-ingredient family

Brand + generics

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

No other applications share this active ingredient.

View full Mirdametinib family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Gomekli: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 219379 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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