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  1. pharmadog
  2. ›drugs
  3. ›Tafinlar
drug
save

dabrafenib mesylate ODT

Marketedupdated 3mo ago
by $NVS NOVARTIS AG
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • drugTAFINLAR160 co-mentions · 40 sources
  • drugdabrafenib mesylate160 co-mentions · 40 sources
  • tagApproval160 co-mentions · 40 sources
  • tagSmall Molecule80 co-mentions · 40 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 2 investigational indications.

all catalysts(40)

approval · 40
May 29, 2013
approval
$NVS160.31+3.73%
13y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Dec 26, 2013
approval
$NVS160.31+3.73%
13y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jan 9, 2014
approval
$NVS160.31+3.73%
13y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Aug 25, 2014
approval
$NVS160.31+3.73%
12y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Nov 20, 2015
approval
$NVS160.31+3.73%
11y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jun 16, 2016
approval
$NVS160.31+3.73%
10y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jun 16, 2017
approval
$NVS160.31+3.73%
9y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jun 22, 2017
approval
$NVS160.31+3.73%
9y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Apr 20, 2018
approval
$NVS160.31+3.73%
8y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Apr 30, 2018
approval
$NVS160.31+3.73%
8y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
May 4, 2018
approval
$NVS160.31+3.73%
8y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jul 16, 2019
approval
$NVS160.31+3.73%
7y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Oct 6, 2019
approval
$NVS160.31+3.73%
7y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Apr 9, 2020
approval
$NVS160.31+3.73%
6y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
May 7, 2021
approval
$NVS160.31+3.73%
5y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Dec 3, 2021
approval
$NVS160.31+3.73%
5y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jan 28, 2022
approval
$NVS160.31+3.73%
5y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Feb 4, 2022
approval
$NVS160.31+3.73%
5y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
May 27, 2022
approval
$NVS160.31+3.73%
4y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jun 22, 2022
approval
$NVS160.31+3.73%
4y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 16, 2023
approval
$NVS160.31+3.73%
3y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 16, 2023
approval
$NVS160.31+3.73%
3y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
May 26, 2023
approval
$NVS160.31+3.73%
3y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Aug 31, 2023
approval
$NVS160.31+3.73%
3y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Feb 27, 2024
approval
$NVS160.31+3.73%
2y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Feb 27, 2024
approval
$NVS160.31+3.73%
2y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 29, 2024
approval
$NVS160.31+3.73%
2y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 29, 2024
approval
$NVS160.31+3.73%
2y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jul 11, 2024
approval
$NVS160.31+3.73%
2y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jul 11, 2024
approval
$NVS160.31+3.73%
2y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jan 30, 2025
approval
$NVS160.31+3.73%
2y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Jan 30, 2025
approval
$NVS160.31+3.73%
2y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 7, 2025
approval
$NVS160.31+3.73%
1y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 7, 2025
approval
$NVS160.31+3.73%
1y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 19, 2025
approval
$NVS160.31+3.73%
1y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 19, 2025
approval
$NVS160.31+3.73%
1y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Apr 7, 2025
approval
$NVS160.31+3.73%
1y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Apr 7, 2025
approval
$NVS160.31+3.73%
1y ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 26, 2026
approval
$NVS160.31+3.73%
5mo ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
Mar 26, 2026
approval
$NVS160.31+3.73%
5mo ago
TAFINLAR (DABRAFENIB MESYLATE) — FDA approval
dabrafenib mesylate ODT
→
view all 40 catalysts →

Trials studying dabrafenib mesylate ODT

  • —Special Drug Use-results Surveillance of Tafinlar/Mekinistrecruitingn=110
  • phase2Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancercompletedn=27

Patent cliff

source: FDA Orange Book
first barrier falls
Sep 16, 2026
27 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (32)

  • Dec 29, 2038patentUS 11504333*PED
  • Jun 29, 2038formulationUS 11504333
  • Feb 28, 2034patentUS 10869869*PED
  • Feb 28, 2034patentUS 10869869*PED
  • Aug 30, 2033method-of-use (U-3185)US 10869869
  • Aug 30, 2033method-of-use (U-3185)US 10869869
  • Apr 15, 2031patentUS 8703781*PED4.7y
  • Apr 15, 2031patentUS 8703781*PED4.7y
  • Apr 15, 2031patentUS 8703781*PED4.7y
  • Apr 15, 2031patentUS 8952018*PED4.7y
  • Apr 15, 2031patentUS 8952018*PED4.7y
  • Oct 15, 2030compositionUS 87037814.2y
  • Oct 15, 2030compositionUS 87037814.2y
  • Oct 15, 2030compositionUS 87037814.2y
  • Oct 15, 2030method-of-use (U-2027)US 89520184.2y
  • Oct 15, 2030method-of-use (U-2027)US 89520184.2y
  • Jul 20, 2030patentUS 7994185*PED3.9y
  • Jul 20, 2030patentUS 7994185*PED3.9y
  • Jul 20, 2030patentUS 7994185*PED3.9y
  • Jul 20, 2030patentUS 8415345*PED3.9y
  • Jul 20, 2030patentUS 8415345*PED3.9y
  • Jul 20, 2030patentUS 8415345*PED3.9y
  • Jan 20, 2030compositionUS 79941853.4y
  • Jan 20, 2030compositionUS 79941853.4y
  • Jan 20, 2030compositionUS 79941853.4y
  • Jan 20, 2030compositionUS 84153453.4y
  • Jan 20, 2030compositionUS 84153453.4y
  • Jan 20, 2030compositionUS 84153453.4y
  • Nov 4, 2029patentUS 9233956*PED3.2y
  • Nov 4, 2029patentUS 9233956*PED3.2y
  • May 4, 2029method-of-use (U-1811)US 92339562.7y
  • May 4, 2029method-of-use (U-2032)US 92339562.7y

FDA exclusivities (12)

  • Sep 16, 2030PEDPediatric (6mo bonus)4.1y
  • Sep 16, 2030PEDPediatric (6mo bonus)4.1y
  • Sep 16, 2030PEDPediatric (6mo bonus)4.1y
  • Mar 16, 2030ODE-428Orphan Drug (7y)3.6y
  • Mar 16, 2030ODE-428Orphan Drug (7y)3.6y
  • Mar 16, 2030ODE-428Orphan Drug (7y)3.6y
  • Sep 16, 2026PEDPediatric (6mo bonus)27d
  • Sep 16, 2026PEDPediatric (6mo bonus)27d
  • Sep 16, 2026PEDPediatric (6mo bonus)27d
  • Mar 16, 2026I-908Indication (3y)
  • Mar 16, 2026NPNP
  • Mar 16, 2026I-908Indication (3y)

News(1)

  • Labcorp nabs FDA green light for BRAF melanoma diagnostic
    The FDA has signed off on Labcorp’s companion diagnostic for patients with advanced melanoma carrying certain BRAF variants.
    fiercebiotech · 9d ago
brand
Tafinlar
generic
dabrafenib mesylate
MOA
Serine/threonine-protein kinase B-raf inhibitor
indication
Low-Grade Glioma
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 49m ago
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