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 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

Generic Entry Date for SELUMETINIB SULFATE^: ⤷ Sign Up* 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
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

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

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Glossary

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

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Country	Patent Number	Title	Estimated Expiration
Denmark	3000810		⤷ Sign Up
European Patent Office	1968948	NOUVEAU SEL HYDROGENOSULFATE (NOVEL HYDROGEN SULFATE SALT)	⤷ Sign Up
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	⤷ Sign Up
Cyprus	1113454		⤷ Sign Up
Spain	2407849		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SELUMETINIB SULFATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	334 8-2019	Slovakia	⤷ Sign Up	PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924
1968948	C202130063	Spain	⤷ Sign Up	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	CR 2021 00044	Denmark	⤷ Sign Up	PRODUCT NAME: SELUMETINIB HYDROGENSULFAT OG SOLVATER OG ANHYDRID FORMER DERAF; REG. NO/DATE: EU/1/21/1552 20210619
1968948	44/2021	Austria	⤷ Sign Up	PRODUCT NAME: SELUMETINIB (EINSCHLIESSLICH JEGLICHE PHARMAZEUTISCHE AKZEPTABLER SALZE (INSBESONDERE HYDROGENSULFATE), ESTER, SOLVATE ODER ENANTIOMERE DAVON); REGISTRATION NO/DATE: EU/1/21/1552 (MITTEILUNG) 20210619
1482932	C01482932/01	Switzerland	⤷ Sign Up	PRODUCT NAME: BINIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66907 01.11.2019
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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