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Orange Book drug · Brand (NDA)

Mekinist

Trametinib Dimethyl Sulfoxide

RLDNDA 204114 3 strengths Novartis
Approved
May 29, 2013
Strengths
3
Listed patents
16
Applications
2

What does the FDA Orange Book show for Mekinist?

Mekinist contains Trametinib Dimethyl Sulfoxide and appears in 2 FDA Orange Book applications. NDA 204114 is the lead filing, with 3 presentations 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 204114

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

Lead application holder
Novartis Pharmaceuticals Corp

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

Product presentations
3

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

Marketing categories
Prescription and Discontinued

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
16

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

Exclusivity records
4

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
001EQ 0.5MGTABLETORALPrescriptionNone posted
RLD
002EQ 1MGTABLETORALDiscontinuedNone posted
RLD
003EQ 2MGTABLETORALPrescriptionNone 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

Novartis Pharmaceuticals Corp

The Orange Book identifies this organization as the applicant responsible for NDA 204114.

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

Status varies by presentation: 2 prescription and 1 on the Discontinued Drug Product List

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

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

16 listed patent expirations and 3 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Feb 28, 2034. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

1 other ANDA 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 204114 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-204114

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.

Strengths & dosage forms

3 approved presentations · NDA 204114
RLD
Strength
EQ 0.5MG
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    13 yr 4 mo ago

  2. Exclusivity ends · I-908

    New indication exclusivity (3 years)

    4 mo ago

  3. Today

  4. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 2 mo

  5. Patent 7378423 expires

    Listed drug substance patent expiration.

    in 10 mo

  6. Patent 7378423*PED expires

    Listed listed patent expiration.

    in 1 yr 4 mo

  7. Exclusivity ends · ODE-428

    Orphan-drug exclusivity (7 years)

    in 3 yr 8 mo

  8. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 4 yr 2 mo

  9. Patent 8703781 expires

    Listed drug substance patent expiration.

    in 4 yr 3 mo

  10. Patent 8703781 expires

    Listed drug substance patent expiration.

    in 4 yr 3 mo

  11. Patent 8703781 expires

    Listed drug substance patent expiration.

    in 4 yr 3 mo

  12. Patent 8703781 expires

    Listed drug substance patent expiration.

    in 4 yr 3 mo

  13. Patent 8703781 expires

    Listed drug substance patent expiration.

    in 4 yr 3 mo

  14. Patent 8952018 expires

    Listed method-of-use patent (U-2020) expiration.

    in 4 yr 3 mo

  15. Patent 8703781*PED expires

    Listed listed patent expiration.

    in 4 yr 9 mo

  16. Patent 8952018*PED expires

    Listed listed patent expiration.

    in 4 yr 9 mo

  17. Patent 8580304 expires

    Listed drug product patent expiration.

    in 5 yr 7 mo

  18. Patent 9155706 expires

    Listed drug product patent expiration.

    in 5 yr 7 mo

  19. Patent 9271941 expires

    Listed drug product patent expiration.

    in 5 yr 7 mo

  20. Patent 9399021 expires

    Listed drug product patent expiration.

    in 5 yr 7 mo

  21. Patent 8580304*PED expires

    Listed listed patent expiration.

    in 6 yr 1 mo

  22. Patent 9155706*PED expires

    Listed listed patent expiration.

    in 6 yr 1 mo

  23. Patent 9271941*PED expires

    Listed listed patent expiration.

    in 6 yr 1 mo

  24. Patent 9399021*PED expires

    Listed listed patent expiration.

    in 6 yr 1 mo

  25. Patent 10869869 expires

    Listed method-of-use patent (U-3184) expiration.

    in 7 yr 2 mo

  26. Patent 10869869*PED expires

    Listed listed patent expiration.

    in 7 yr 8 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032203320342035TodayExclusivity I-908: 2026-03-16Exclusivity I-908Exclusivity PED: 2026-09-16Exclusivity PEDPatent 7378423: 2027-05-29Patent 7378423Patent 7378423*PED: 2027-11-29Patent 7378423*PEDExclusivity ODE-428: 2030-03-16Exclusivity ODE-428Exclusivity PED: 2030-09-16Exclusivity PEDPatent 8703781: 2030-10-15Patent 8703781Patent 8703781: 2030-10-15Patent 8703781Patent 8703781: 2030-10-15Patent 8703781Patent 8703781: 2030-10-15Patent 8703781Patent 8703781: 2030-10-15Patent 8703781Patent 8952018: 2030-10-15Patent 8952018Patent 8703781*PED: 2031-04-15Patent 8703781*PEDPatent 8952018*PED: 2031-04-15Patent 8952018*PEDPatent 8580304: 2032-01-28Patent 8580304Patent 9155706: 2032-01-28Patent 9155706Patent 9271941: 2032-01-28Patent 9271941Patent 9399021: 2032-01-28Patent 9399021Patent 8580304*PED: 2032-07-28Patent 8580304*PEDPatent 9155706*PED: 2032-07-28Patent 9155706*PEDPatent 9271941*PED: 2032-07-28Patent 9271941*PEDPatent 9399021*PED: 2032-07-28Patent 9399021*PEDPatent 10869869: 2033-08-30Patent 10869869Patent 10869869*PED: 2034-02-28Patent 10869869*PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Strength

EQ 0.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 204114

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • I-908New indication exclusivity (3 years)

    4 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    in 2 mo

  • ODE-428Orphan-drug exclusivity (7 years)

    in 3 yr 8 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 4 yr 2 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7378423in 10 mo
SubstanceProduct
7378423*PEDin 1 yr 4 mo
8703781in 4 yr 3 mo
SubstanceProductU-2305
8703781in 4 yr 3 mo
SubstanceProductU-1712
8703781in 4 yr 3 mo
SubstanceProductU-2020
8703781in 4 yr 3 mo
SubstanceProductU-2302
8703781in 4 yr 3 mo
SubstanceProductU-2037
8952018in 4 yr 3 mo
U-2020
8703781*PEDin 4 yr 9 mo
8952018*PEDin 4 yr 9 mo
8580304in 5 yr 7 mo
Product
9155706in 5 yr 7 mo
Product
9271941in 5 yr 7 mo
Product
9399021in 5 yr 7 mo
Product
8580304*PEDin 6 yr 1 mo
9155706*PEDin 6 yr 1 mo
9271941*PEDin 6 yr 1 mo
9399021*PEDin 6 yr 1 mo
10869869in 7 yr 2 mo
U-3184
10869869*PEDin 7 yr 8 mo

Other FDA applications for Mekinist

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 Mekinist, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
ApplicationApplicantApprovedStrengthsTE codeStatus
NDA 217513NovartisMar 16, 20231—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.

View full Trametinib Dimethyl Sulfoxide 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.

Mekinist: 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 204114 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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