Selumetinib sulfate - Generic Drug Details

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 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
United States Department of Defense	Phase 2
Sarcoma Alliance for Research through Collaboration	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

Anatomical Therapeutic Chemical (ATC) Classes for selumetinib sulfate

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

Expired US Patents for selumetinib sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020

International Patents for selumetinib sulfate

Country	Patent Number	Title	Estimated Expiration
Japan	5498546
China	1652776	N3 alkylated benzimidazole derivatives as MEK inhibitors
Iceland	7442	N3 alkýleraðar bensimíðasól afleiður sem MEK hindrar
Poland	1968948
Portugal	1968948
China	101633644	N3 alkylated benzimidazole derivatives as mek inhibitors
Serbia	52843	NOVA SO VODONIK SULFATA (NOVEL HYDROGEN SULFATE SALT)

Supplementary Protection Certificates for selumetinib sulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1968948	2190048-5	Sweden		PRODUCT NAME: SELUMETINIB HYDROGEN SULFATE, INCLUDING ANY SOLVATES AND ANHYDROUS FORMS THEREOF; REG. NO/DATE: EU/1/21/1552 20210619
1968948	122021000074	Germany		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		PRODUCT NAME: SELUMETINIB HYDROGENSULFAT OG SOLVATER OG ANHYDRID FORMER DERAF; REG. NO/DATE: EU/1/21/1552 20210619
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	PA2021530	Lithuania		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		PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018
1968948	LUC00234	Luxembourg		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