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-five patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for trametinib dimethyl sulfoxide
International Patents: | 165 |
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 |
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 | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-003 | May 29, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114-002 | May 29, 2013 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 |
---|---|---|---|
Argentina | 084102 | COMPRIMIDO FARMACEUTICO QUE COMPRENDE EL SOLVATO DE DIMETILSULFOXIDO DE LA N-{3-[3-CICLOPROPIL-5-(2-FLUORO-4-YODO-FENILAMINO)-6,8-DIMETIL-2,4,7-TRIOXO-3,4,6,7-TETRAHIDRO-2H-PIRIDO[4,3-D]PIRIMIDIN-1-IL]FENIL}ACETAMIDA, SU USO PARA PREPARAR UN MEDICAMENTO UTIL PARA TRATAR EL CANCER EN UN SER HUMANO Y PROCEDIMIENTO PARA PREPARAR DICHOS COMPRIMIDOS | ⤷ Try a Trial |
Russian Federation | 2015105821 | Способ адъювантного лечения рака | ⤷ Try a Trial |
New Zealand | 552090 | 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 | ⤷ Try a Trial |
Peru | 20121093 | COMBINACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE MEK Y UN INHIBIDOR DE B-RAF | ⤷ Try a Trial |
>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 | 1490063-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702 |
1761528 | CA 2014 00055 | Denmark | ⤷ Try a Trial | 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 | PA2014039 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630 |
1761528 | C20140036 00120 | Estonia | ⤷ Try a Trial | CHANGE OF OWNER'S ADDRESS |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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