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 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

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

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

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				Y
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			Y	Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No				Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes
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
Argentina	058696	SAL DE SULFATO DE HIDROGENO DEL ACIDO 6-(4-BROMO-2-CLORO-FENILAMINO)-7-FLUOR-3-METIL-3H-BENZOIMIDAZOL-5-CARBOXILICO.
Lithuania	C1482932
Israel	204419	DERIVATIVES OF BENZOIMIDAZOLE-5-CARBOXYLIC ACID AMIDE
Japan	4093966
Russian Federation	2010143906	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ 271
Poland	233493

Supplementary Protection Certificates for SELUMETINIB SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1968948	C202130063	Spain		PRODUCT NAME: SELUMETINIB HIDROGENOSULFATO, INCLUYENDO SOLVATOS Y FORMAS ANHIDRAS DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1552; DATE OF AUTHORISATION: 20210617; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1552; DATE OF FIRST AUTHORISATION IN EEA: 20210617
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
1482932	1990010-9	Sweden		PRODUCT NAME: BINIMETINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES THEROF; REG. NO/DATE: EU/1/18/1315 20180924
1482932	PA2019007,C1482932	Lithuania		PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1968948	CR 2021 00044	Denmark		PRODUCT NAME: SELUMETINIB HYDROGENSULFAT OG SOLVATER OG ANHYDRID FORMER DERAF; REG. NO/DATE: EU/1/21/1552 20210619
1482932	CA 2019 00011	Denmark		PRODUCT NAME: BINIMETINIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 20180924