Pharsight

Mekinist is owned by Novartis.

Mekinist contains Trametinib Dimethyl Sulfoxide.

Mekinist has a total of 18 drug patents out of which 0 drug patents have expired.

Mekinist was authorised for market use on 16 March, 2023.

Mekinist is available in solution;oral dosage forms.

Mekinist can be used as mekinist(r) is indicated, in combination with dabrafenib, 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, mekinist is indicated, as a single agent or in combination with dabrafenib, 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 unresectable or metastatic melanoma; mekinist is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test; in combination with dabrafenib for the treatment of unresectable or metastatic melanoma.; mekinist is indicated, in combination with dabrafenib, 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; mekinist is indicated, in combination with dabrafenib, 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, mekinist is indicated, in combination with dabrafenib, 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; mekinist is indicated, in combination with dabrafenib, 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; mekinist is indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an fda-approved test; mekinist in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma; mekinist is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test, mekinist is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (nsclc) with braf v600e mutation as detected by an fda-approved test.

The generics of Mekinist are possible to be released after 02 March, 2034.

Application	Filing Date	Opposition Party	Legal Status
EP13835019A	2022-06-22	Generics [UK] Limited	Granted and Under Opposition
EP13835019A	2022-06-21	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP13835019A	2022-06-20	STADA Arzneimittel AG	Granted and Under Opposition
EP11849974A	2021-04-01	Generics [UK] Limited	Granted and Under Opposition
EP11849974A	2021-04-01	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP10824148A	2020-03-12	Teva Pharmaceutical Industries Ltd	Opposition rejected
EP10824148A	2020-03-12	Generics (UK) Ltd	Opposition rejected

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Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7378423	NOVARTIS	Pyrimidine compound and medical use thereof	May, 2027 (3 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)
US7378423 (Pediatric)	NOVARTIS	Pyrimidine compound and medical use thereof	Nov, 2027 (4 years from now)
US8952018	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors	Oct, 2030 (7 years from now)
US8703781 (Pediatric)	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors	Apr, 2031 (7 years from now)
US8952018 (Pediatric)	NOVARTIS	Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors	Apr, 2031 (7 years from now)
US9399021	NOVARTIS	Pharmaceutical composition	Jan, 2032 (8 years from now)
US9271941	NOVARTIS	Pharmaceutical composition	Jan, 2032 (8 years from now)
US9155706	NOVARTIS	Pharmaceutical composition	Jan, 2032 (8 years from now)
US8580304	NOVARTIS	Pharmaceutical composition	Jan, 2032 (8 years from now)
US9155706 (Pediatric)	NOVARTIS	Pharmaceutical composition	Jul, 2032 (9 years from now)
US8580304 (Pediatric)	NOVARTIS	Pharmaceutical composition	Jul, 2032 (9 years from now)
US9271941 (Pediatric)	NOVARTIS	Pharmaceutical composition	Jul, 2032 (9 years from now)
US9399021 (Pediatric)	NOVARTIS	Pharmaceutical composition	Jul, 2032 (9 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)	Mar 16, 2030
New Product (NP)	Mar 16, 2026

Drugs and Companies using TRAMETINIB DIMETHYL SULFOXIDE ingredient

Market Authorisation Date: 16 March, 2023

Treatment: Mekinist is indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with braf v600e or v600k mutations, as detected by an...

Dosage: SOLUTION;ORAL