KOSELUGO Drug Patent Profile

Which patents cover Koselugo, and what generic alternatives are available?

Koselugo is a drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and fifty-eight patent family members in thirty-nine countries.

The generic ingredient in KOSELUGO is selumetinib sulfate. One supplier is listed for this compound. Additional details are available on the selumetinib sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Koselugo

Koselugo will be eligible for patent challenges on April 10, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 10, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for KOSELUGO

International Patents:	158
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	9
Patent Applications:	2,811
Drug Prices:	Drug price information for KOSELUGO
What excipients (inactive ingredients) are in KOSELUGO?	KOSELUGO excipients list
DailyMed Link:	KOSELUGO at DailyMed

See drug prices for KOSELUGO

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for KOSELUGO

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)

NDA:

213756

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 KOSELUGO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AstraZeneca	Phase 1
Merck Sharp & Dohme Corp.	Phase 1
National Cancer Institute (NCI)	Phase 3

See all KOSELUGO clinical trials

Pharmacology for KOSELUGO

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 KOSELUGO

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 KOSELUGO

KOSELUGO is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting KOSELUGO

FDA Regulatory Exclusivity protecting KOSELUGO

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			Y	Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes			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

International Patents for KOSELUGO

When does loss-of-exclusivity occur for KOSELUGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Netherlands

New Zealand

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KOSELUGO around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03077914
China	1874768	N3 alkylated benzimidazole derivatives as MEK inhibitors
Taiwan	201031642	N3 alkylated benzimidazole derivative as MEK inhibitors
Argentina	045738	DERIVADOS DE BENCIMIDAZOL N3 ALQUILADOS COMO INHIBIDORES DE MEK

Supplementary Protection Certificates for KOSELUGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	LUC00100	Luxembourg		PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
1482932	2019C/510	Belgium		PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
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
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