Orange Book product · Brand (NDA)

MEKINIST

TRAMETINIB DIMETHYL SULFOXIDE

Brand (NDA)NDA 217513RX NOVARTIS

Mar 16, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 16, 2023
3 yr 4 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
Mar 16, 2026
3 mo ago
Today
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Sep 16, 2026
in 3 mo
Patent 7378423 expires
Listed drug substance patent expiration.
May 29, 2027
in 11 mo
Patent 7378423*PED expires
Listed listed patent expiration.
Nov 29, 2027
in 1 yr 6 mo
Exclusivity ends · ODE-428
Orphan-drug exclusivity (7 years)
Mar 16, 2030
in 3 yr 10 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Sep 16, 2030
in 4 yr 4 mo
Patent 8703781 expires
Listed drug substance patent expiration.
Oct 15, 2030
in 4 yr 5 mo
Patent 8703781*PED expires
Listed listed patent expiration.
Apr 15, 2031
in 4 yr 11 mo

Active ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Strength

EQ 0.05MG BASE/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 217513

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7378423	May 29, 2027	in 11 mo	SubstanceProduct
7378423*PED	Nov 29, 2027	in 1 yr 6 mo
8703781	Oct 15, 2030	in 4 yr 5 mo	SubstanceProductU-3564
8703781*PED	Apr 15, 2031	in 4 yr 11 mo