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Last Updated: February 4, 2023

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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selumetinib sulfate has one hundred and fifty-eight patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for selumetinib sulfate
International Patents:158
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 19
Clinical Trials: 37
Patent Applications: 55
DailyMed Link:selumetinib sulfate at DailyMed
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 213756-002 Apr 10, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Russian Federation 2004127926 N3-АЛКИЛИРОВАННЫЕ БЕНЗИМИДАЗОЛЬНЫЕ ПРОИЗВОДНЫЕ В КАЧЕСТВЕ ИНГИБИТОРОВ MEK See Plans and Pricing
Ukraine 93531 НОВИЙ ГІДРОСУЛЬФАТ[НОВЫЙ ГИДРОСУЛЬФАТ (NOVEL HYDROGEN SULFATE SALT) See Plans and Pricing
South Korea 20040094786 See Plans and Pricing
Ecuador SP088597 SAL DE SULFATO DE HIDRÓGENO NOVEDOSA See Plans and Pricing
Hungary E025767 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for selumetinib sulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1482932 334 8-2019 Slovakia See Plans and Pricing PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924
1968948 301139 Netherlands See Plans and Pricing PRODUCT NAME: SELUMETINIBWATERSTOFSULFAAT, DESGEWENST IN WATERVRIJE VORM OF IN DE VORM VAN EEN SOLVAAT; REGISTRATION NO/DATE: EU/1/21/1552 20210619
1968948 CA 2021 00044 Denmark See Plans and Pricing PRODUCT NAME: SELUMETINIB, INKLUSIV FARMACEUTISK ACCEPTABLE SALTE (ISAER HYDROGENSULFAT), ESTRE, SOLVATER OG ENANTIOMERE DERAF; REG. NO/DATE: EU/1/21/1552 20210619
1482932 C20190010 00281 Estonia See Plans and Pricing PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018
1482932 C 2019 008 Romania See Plans and Pricing PRODUCT NAME: BINIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF NATIONAL AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Express Scripts
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.