Selumetinib sulfate - Generic Drug Details

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 3
Sarcoma Alliance for Research through Collaboration	Phase 2
United States Department of Defense	Phase 2

See all selumetinib sulfate clinical trials

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

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
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No			Y	Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes			Y	Y

International Patents for selumetinib sulfate

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2004127926	N3-АЛКИЛИРОВАННЫЕ БЕНЗИМИДАЗОЛЬНЫЕ ПРОИЗВОДНЫЕ В КАЧЕСТВЕ ИНГИБИТОРОВ MEK
Ukraine	93531	НОВИЙ ГІДРОСУЛЬФАТ[НОВЫЙ ГИДРОСУЛЬФАТ (NOVEL HYDROGEN SULFATE SALT)
South Korea	20040094786
Ecuador	SP088597	SAL DE SULFATO DE HIDRÓGENO NOVEDOSA
Hungary	E025767

Supplementary Protection Certificates for selumetinib sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	334 8-2019	Slovakia		PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924
1968948	301139	Netherlands		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		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		PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018
1482932	C 2019 008	Romania		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