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 two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Trametinib dimethyl sulfoxide has one hundred and sixty-nine patent family members in forty-six countries.
One supplier is listed for this compound.
Summary for TRAMETINIB DIMETHYL SULFOXIDE
International Patents: | 169 |
US Patents: | 12 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 55 |
Clinical Trials: | 15 |
Patent Applications: | 311 |
DailyMed Link: | TRAMETINIB DIMETHYL SULFOXIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRAMETINIB DIMETHYL SULFOXIDE
Generic Entry Dates for TRAMETINIB DIMETHYL SULFOXIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
Generic Entry Dates for TRAMETINIB DIMETHYL SULFOXIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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
Paragraph IV (Patent) Challenges for TRAMETINIB DIMETHYL SULFOXIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MEKINIST | Tablets | trametinib dimethyl sulfoxide | 0.5 mg and 2 mg | 204114 | 1 | 2023-09-28 |
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 | 204114-003 | May 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-001 | May 29, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-003 | May 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-003 | May 29, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 |
---|---|---|---|
European Patent Office | 2298768 | Dérivés 5-amino-2,4,7-trioxo-3,4,7,8-tetrahydro-2H-pyrido[2,3-d]pyrimidine et composés similaires pour le traitement de cancer (5-amino-2,4,7-trioxo-3,4,7,8-tetrahydro-2H-pyrido[2,3-d]pyrimidine derivatives and related compounds for the treatment of cancer) | ⤷ Sign Up |
Lithuania | 2654736 | ⤷ Sign Up | |
Mexico | 2012004413 | COMBINACION. (COMBINATION.) | ⤷ Sign Up |
Ukraine | 113158 | ФАРМАЦЕВТИЧНА ТАБЛЕТКА | ⤷ Sign Up |
European Patent Office | 2654736 | NOUVELLE COMPOSITION PHARMACEUTIQUE (NOVEL PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
Netherlands | 300701 | ⤷ Sign Up | |
Norway | 338355 | ⤷ Sign Up | |
>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 | 565 | Finland | ⤷ Sign Up | |
1761528 | C20140036 00120 | Estonia | ⤷ Sign Up | CHANGE OF OWNER'S ADDRESS |
1761528 | PA2014039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
1761528 | C 2014 044 | Romania | ⤷ Sign Up | 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 | 2014/063 | Ireland | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/14/931/001-006 20140702 |
1761528 | CA 2014 00055 | Denmark | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630 |
1761528 | 205 5032-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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