Selumetinib sulfate - Generic Drug Details
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What are the generic drug sources for selumetinib sulfate and what is the scope of freedom to operate?
Selumetinib sulfate
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Selumetinib sulfate has one hundred and ninety-eight patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for selumetinib sulfate
International Patents: | 198 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 37 |
Patent Applications: | 42 |
DailyMed Link: | selumetinib sulfate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for selumetinib sulfate
Generic Entry Date for selumetinib sulfate*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) Dosage:
CAPSULE;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 selumetinib sulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 3 |
Sarcoma Alliance for Research through Collaboration | Phase 2 |
United States Department of Defense | Phase 2 |
Pharmacology for selumetinib sulfate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Mitogen-Activated Protein Kinase Kinase 1 Inhibitors Mitogen-Activated Protein Kinase Kinase 2 Inhibitors |
US Patents and Regulatory Information for selumetinib sulfate
International Patents for selumetinib sulfate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2009521487 | ⤷ Try a Trial | |
European Patent Office | 2130536 | Dérivés de benzimidazole d'alkylat N3 en tant qu'inhibiteurs de Mek (N3 alkylated benzimidazole derivatives as mek inhibitors) | ⤷ Try a Trial |
New Zealand | 588849 | PHARMACEUTICAL COMPOSITION COMPRISING 6-(4-BROMO-2-CHLORO-PHENYLAMINO)-7-FLUORO-3-METHYL-3H-BENZOIMIDAZOLE-5-CARBOXYLIC ACID (2-HYDROXY-ETHOXY)-AMIDE | ⤷ Try a Trial |
Denmark | 2130537 | ⤷ Try a Trial | |
Ukraine | 77765 | N3 ALKYLATED DERIVATIVES OF BENZIMIDAZOLE AS MEK INHIBITORS | ⤷ Try a Trial |
New Zealand | 569792 | Novel hydrogen sulphate benzimidazole salt | ⤷ Try a Trial |
Croatia | P20130663 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for selumetinib sulfate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1968948 | 2190048-5 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SELUMETINIB HYDROGEN SULFATE, INCLUDING ANY SOLVATES AND ANHYDROUS FORMS THEREOF; REG. NO/DATE: EU/1/21/1552 20210619 |
1968948 | 122021000074 | Germany | ⤷ Try a Trial | PRODUCT NAME: SELUMETINIB (EINSCHLIESSLICH PHARMAZEUTISCH AKZEPTABLER SALZE (INSBESONDERE HYDROGENSULFAT), ESTER, SOLVATE ODER ENANTIOMERE DAVON); REGISTRATION NO/DATE: EU/1/21/1552 20210617 |
1968948 | CR 2021 00044 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SELUMETINIB HYDROGENSULFAT OG SOLVATER OG ANHYDRID FORMER DERAF; REG. NO/DATE: EU/1/21/1552 20210619 |
1968948 | 301139 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SELUMETINIBWATERSTOFSULFAAT, DESGEWENST IN WATERVRIJE VORM OF IN DE VORM VAN EEN SOLVAAT; REGISTRATION NO/DATE: EU/1/21/1552 20210619 |
1968948 | PA2021530 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SELUMETINIBAS, ISKAITANT JO BET KURIA FARMACINIU POZIURIU PRIIMTINA DRUSKA, BUTENT VANDENILIO SULFATA, JO ESTERIUS, SOLVATUS ARBA ENANTIOMERUS; REGISTRATION NO/DATE: EU/1/21/1552 20210617 |
1482932 | C20190010 00281 | Estonia | ⤷ Try a Trial | PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018 |
1968948 | LUC00234 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SELUMETINIB (INCLUANT TOUS SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER LE SULFATE D'HYDROGENE), SES ESTERS, SOLVATES ET ENANTIOMERES); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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