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Last Updated: March 28, 2024

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

SponsorPhase
National Cancer Institute (NCI)Phase 3
Sarcoma Alliance for Research through CollaborationPhase 2
United States Department of DefensePhase 2

See all selumetinib sulfate clinical trials

US Patents and Regulatory Information for selumetinib sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y 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 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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