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Last Updated: November 4, 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
United States Department of DefensePhase 2
Sarcoma Alliance for Research through CollaborationPhase 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 213756-002 Apr 10, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y 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 selumetinib sulfate

Country Patent Number Title Estimated Expiration
Hong Kong 1153139 作為 抑制劑的 烷基化苯並咪唑衍生物 (N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS MEK N3) ⤷  Sign Up
Lithuania C1482932 ⤷  Sign Up
Saudi Arabia 109300195 تركيبة صيدلانية جديدة مضادة للسرطان (A Novel Anti-Cancer Pharmaceutical Composition) ⤷  Sign Up
Japan 2009521487 ⤷  Sign Up
China 101633644 N3 alkylated benzimidazole derivatives as mek inhibitors ⤷  Sign Up
Denmark 1482932 ⤷  Sign Up
Taiwan I343377 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for selumetinib sulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1968948 2021C/549 Belgium ⤷  Sign Up 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
1482932 PA2019007,C1482932 Lithuania ⤷  Sign Up PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1482932 122019000022 Germany ⤷  Sign Up PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1482932 14/2019 Austria ⤷  Sign Up PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924
1482932 C01482932/01 Switzerland ⤷  Sign Up PRODUCT NAME: BINIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66907 01.11.2019
1482932 PA2019007 Lithuania ⤷  Sign Up PRODUCT NAME: BINIMETINIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1968948 LUC00234 Luxembourg ⤷  Sign Up 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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