Trametinib dimethyl sulfoxide - Generic Drug Details
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What are the generic sources for trametinib dimethyl sulfoxide and what is the scope of freedom to operate?
Trametinib dimethyl sulfoxide
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Trametinib dimethyl sulfoxide has one hundred and sixty patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for trametinib dimethyl sulfoxide
International Patents: | 160 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 15 |
Patent Applications: | 367 |
DailyMed Link: | trametinib dimethyl sulfoxide at DailyMed |
Recent Clinical Trials for trametinib dimethyl sulfoxide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
ECOG-ACRIN Cancer Research Group | Phase 2 |
Pediatric Brain Tumor Consortium | Phase 1/Phase 2 |
National Cancer Institute (NCI) | Phase 3 |
Pharmacology for trametinib dimethyl sulfoxide
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for trametinib dimethyl sulfoxide
US Patents and Regulatory Information for trametinib dimethyl sulfoxide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-001 | May 29, 2013 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-001 | May 29, 2013 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for trametinib dimethyl sulfoxide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2019142899 | アジュバント癌治療の方法 (METHOD OF ADJUVANT CANCER TREATMENT) | See Plans and Pricing |
Spain | 2297723 | See Plans and Pricing | |
Serbia | 63702 | KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for trametinib dimethyl sulfoxide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1761528 | C 2014 044 | Romania | See Plans and Pricing | PRODUCT NAME: TRAMETINIB, OPTIONAL SUB FORMA UNEI SARI, HIDRAT SAU SOLVAT AL ACESTUIA, ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/14/931; DATE OF NATIONAL AUTHORISATION: 20140630; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/931; DATE OF FIRST AUTHORISATION IN EEA: 20140630 |
1761528 | PA2014039,C1761528 | Lithuania | See Plans and Pricing | PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
1761528 | C300701 | Netherlands | See Plans and Pricing | PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FRAMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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