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Last Updated: April 17, 2024

Selumetinib sulfate - Generic Drug Details


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What are the generic sources for selumetinib sulfate and what is the scope of patent protection?

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 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 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 213756-002 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 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
>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
Mexico 2010010671 COMPOSICION FARMACEUTICA 271. (PHARMACEUTICAL COMPOSITION 271.) ⤷  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
Taiwan 201031641 N3 alkylated benzimidazole derivative as MEK inhibitors ⤷  Try a Trial
South Korea 20080080200 NOVEL HYDROGEN SULFATE SALT ⤷  Try a Trial
Cyprus 1114303 ⤷  Try a Trial
Iceland 2999 ⤷  Try a Trial
Germany 60330227 ⤷  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 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 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
1482932 2019C/510 Belgium ⤷  Try a Trial PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
1482932 19C1014 France ⤷  Try a Trial PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1315 20180924
1968948 44/2021 Austria ⤷  Try a Trial PRODUCT NAME: SELUMETINIB (EINSCHLIESSLICH JEGLICHE PHARMAZEUTISCHE AKZEPTABLER SALZE (INSBESONDERE HYDROGENSULFATE), ESTER, SOLVATE ODER ENANTIOMERE DAVON); REGISTRATION NO/DATE: EU/1/21/1552 (MITTEILUNG) 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 2021C/549 Belgium ⤷  Try a Trial PRODUCT NAME: SELUMETINIB (Y COMPRIS TOUS SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER HYDROGENOSULFATE), ESTERS, SOLVATES OU ENANTIOMERES DE CEUX-CI); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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