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TAFINLAR (DABRAFENIB MESYLATE) | LOERadar
Viewing data from:
Latest
2026-07-01
2026-06-01
2026-05-01
2026-04-01
2026-03-28
2026-02-17
2026-02-10
2025-12-14
2025-02-26
2025-01-25
2024-11-08
2023-07-23
2023-06-15
2023-05-13
2023-01-26
2022-11-22
2022-10-28
2022-09-29
2022-07-09
2022-06-29
2022-04-08
2022-03-09
2021-12-28
2021-05-05
2021-03-12
2020-12-22
2020-11-12
2019-12-14
2019-09-15
TAFINLAR
NDA
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DABRAFENIB MESYLATE | N217514 | NOVARTIS PHARMACEUTICALS CORP
1 strength
4 unique patents
3 unique exclusivities
Patents
SEC Intel
Revenue
PTAB
Reexams
Litigation
Petitions
Trials
DMF
Approvals
Label
Products
Patent Timeline
4 unique patents, 2 exclusivities by expiration date
Active (4)
Today
PED (+6 mo)
Exclusivity
2026
2027
2028
2029
2030
2031
2032
2033
2034
2035
2036
2037
2038
2039
Today
7994185
Jul. 20, 2030
8415345
Jul. 20, 2030
8703781
Apr. 15, 2031
11504333
Dec. 29, 2038
NP
Sep. 16, 2030
ODE-428
Sep. 16, 2030
PTAB Proceedings
No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board
Hatch-Waxman Litigation
No ANDA patent litigation cases (NOS 835) matched from PACER
Citizen Petitions
No FDA citizen petitions matched from Regulations.gov
Products (1)
#001 — EQ 10MG BASE
RLD
4 patents
3 exclusivities
▴
TABLET, FOR SUSPENSION;ORAL | Approved: Mar 16, 2023
Patents (4)
Patent #
Expiration
PED
Drug Substance
Drug Product
Use Code
Delist
7994185
Jan 20, 2030
PED: Jul 20, 2030
PED
Yes
Yes
—
—
8415345
Jan 20, 2030
PED: Jul 20, 2030
PED
Yes
Yes
—
—
8703781
Oct 15, 2030
PED: Apr 15, 2031
PED
Yes
Yes
U-3565
TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
—
11504333
Jun 29, 2038
PED: Dec 29, 2038
PED
—
Yes
—
—
Exclusivities (3)
Code
Date
Status
NP
Mar 16, 2026
Expired
ODE-428
Mar 16, 2030
Active
PED
Sep 16, 2030
Active