Tafinlar is owned by Novartis.
Tafinlar contains Dabrafenib Mesylate.
Tafinlar has a total of 14 drug patents out of which 0 drug patents have expired.
Tafinlar was authorised for market use on 29 May, 2013.
Tafinlar is available in capsule;oral dosage forms.
Tafinlar can be used as tafinlar(r) is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test., tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection; tafinlar is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test.; treatment of melanoma; tafinlar is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fda-approved test, tafinlar(r) is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test.; tafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment options; tafinlar(r) is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test.; tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection, tafinlar(r) is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations as detected by an fda-approved test, and involvement of lymph node(s), following complete resection, tafinlar is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test.; tafinlar is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fda-approved test; treatment of melanoma; tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection, tafinlar is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test.; tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection; treatment of patients with unresectable or metastatic melanoma with braf v600e mutations after confirming the presence of braf v600e mutation; tafinlar is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fda-approved test, tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection; tafinlar in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma; tafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment options; tafinlar is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test..
The generics of Tafinlar are possible to be released after 02 March, 2034.
Patent Number | Company | Patent Title | Patent Expiry | Activity Alert |
---|---|---|---|---|
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance. | ||||
US7994185 | NOVARTIS | Benzene sulfonamide thiazole and oxazole compounds |
Jan, 2030
(6 years from now) | |
US8415345 | NOVARTIS | Benzene sulfonamide thiazole and oxazole compounds |
Jan, 2030
(6 years from now) | |
US8703781 | NOVARTIS | Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors |
Oct, 2030
(7 years from now) | |
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
US8835443 | NOVARTIS | Pyrimidine compound and medical use thereof |
Jun, 2025
(2 years from now) | |
US8835443
(Pediatric) | NOVARTIS | Pyrimidine compound and medical use thereof |
Dec, 2025
(2 years from now) | |
US9233956 | NOVARTIS | Benzene sulfonamide thiazole and oxazole compounds |
May, 2029
(6 years from now) | |
US9233956
(Pediatric) | NOVARTIS | Benzene sulfonamide thiazole and oxazole compounds |
Nov, 2029
(6 years from now) | |
US7994185
(Pediatric) | NOVARTIS | Benzene sulfonamide thiazole and oxazole compounds |
Jul, 2030
(7 years from now) | |
US8415345
(Pediatric) | NOVARTIS | Benzene sulfonamide thiazole and oxazole compounds |
Jul, 2030
(7 years from now) | |
US8952018 | NOVARTIS | Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors |
Oct, 2030
(7 years from now) | |
US8952018
(Pediatric) | NOVARTIS | Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors |
Apr, 2031
(8 years from now) | |
US8703781
(Pediatric) | NOVARTIS | Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors |
Apr, 2031
(8 years from now) | |
US10869869 | NOVARTIS | Method of adjuvant cancer treatment |
Aug, 2033
(10 years from now) | |
US10869869
(Pediatric) | NOVARTIS | Method of adjuvant cancer treatment |
Mar, 2034
(10 years from now) |
Exclusivity | Exclusivity Expiration |
---|---|
Orphan Drug Exclusivity (ODE) | Jun 22, 2024 |
New Indication (I) | Jun 22, 2025 |
Pediatric Exclusivity (PED) | Oct 30, 2025 |
Drugs and Companies using DABRAFENIB MESYLATE ingredient
Market Authorisation Date: 29 May, 2013
Treatment: Tafinlar(r) is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test.; Tafinlar is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (atc) with braf v600e mutation and with no satisfactory locoregional treatment options; Tafinlar(r) is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test.; Tafinlar is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations, as detected by an fda-approved test, and involvement of lymph node(s), following complete resection; Tafinlar is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test.; Treatment of patients with unresectable or metastatic melanoma with braf v600e mutations after confirming the presence of braf v600e mutation; Tafinlar is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with braf v600e mutation as detected by an fda-approved test; Tafinlar(r) is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with braf v600e or v600k mutations as detected by an fda-approved test, and involvement of lymph node(s), following complete resection; Treatment of melanoma; Tafinlar in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma
Dosage: CAPSULE;ORAL
32
United States
11
Japan
9
European Union
6
Spain
6
Croatia
6
China
6
Poland
6
Denmark
5
Portugal
5
Canada
5
Slovenia
5
Australia
5
RS
4
Brazil
4
Korea, Republic of
4
Hungary
3
New Zealand
3
Mexico
3
Hong Kong
3
South Africa
3
Lithuania
3
Cyprus
2
Malaysia
2
Russia
2
Colombia
2
Dominican Republic
2
Norway
2
Morocco
2
Peru
2
EA
2
Ukraine
2
ME
2
Israel
2
Chile
1
Germany
1
Singapore
1
Uruguay
1
Jordan
1
Costa Rica
1
Argentina
1
Austria
1
Taiwan, Province of China
1
India
1
Luxembourg
1
Netherlands
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