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

International Patents for SELUMETINIB SULFATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005023251
Portugal	2271321
Spain	2549159
South Africa	201006766	PHARMACEUTICAL COMPOSITION 271
Russian Federation	2010143906	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ 271
Dominican Republic	P2013000023	UN COMPUESTO SELECCIONADO DEL ACIDO 6-(4-BROMO-2-CLORO-FENILAMINO) -7-FLUROR-3-METIL-3H-BENZOIMIDAZOL -5-CARBOXILICO (2-HIDROXI-ETOXI)-AMIDA Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, Y COMPOSICIONES FARMACEUTICAS QUE CONTIENEN DICHO COMPUESTO
European Patent Office	3000810	DÉRIVÉ DE BENZIMIDAZOLE D'ALKYLAT N3 EN TANT QU'INHIBITEUR DE MEK (N3 ALKYLATED BENZIMIDAZOLE DERIVATIVE AS MEK INHIBITOR)

Supplementary Protection Certificates for SELUMETINIB SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	14/2019	Austria		PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924
1968948	C 2021 039	Romania		PRODUCT NAME: SULFAT ACID DE SELUMETINIB INCLUZAND ORICE SOLVATI SI FORME ANHIDRE ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1552; DATE OF NATIONAL AUTHORISATION: 20210617; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1552; DATE OF FIRST AUTHORISATION IN EEA: 20210617
1482932	122019000022	Germany		PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920
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
1482932	C20190010 00281	Estonia		PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018
1482932	C201930018	Spain		PRODUCT NAME: BINIMETINIB O UNA SAL O UN SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
1482932	SPC/GB19/007	United Kingdom		PRODUCT NAME: BINIMETINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/18/1315/001-002 20180920