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				⤷ Sign Up
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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
Spain	2394347		⤷ Sign Up
Singapore	2013013339	N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS	⤷ Sign Up
Mexico	2008008298	SAL DE SULFATO DE HIDROGENO NOVEDOSA. (NOVEL HYDROGEN SULFATE SALT.)	⤷ Sign Up
Iceland	2748		⤷ 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
1968948	C 2021 039	Romania	⤷ Sign Up	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	PA2019007,C1482932	Lithuania	⤷ Sign Up	PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1968948	PA2021530	Lithuania	⤷ Sign Up	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	CR 2019 00011	Denmark	⤷ Sign Up	PRODUCT NAME: BINIMETINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1315 20180924
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.