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Last Updated: December 8, 2024

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KOSELUGO Drug Patent Profile


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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 five patents protecting this drug.

This drug has one hundred and ninety-eight patent family members in forty-four 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 was eligible for patent challenges on April 10, 2024.

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

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Summary for KOSELUGO
International Patents:198
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 129
Clinical Trials: 12
Patent Applications: 1,933
Drug Prices: Drug price information for KOSELUGO
What excipients (inactive ingredients) are in KOSELUGO?KOSELUGO excipients list
DailyMed Link:KOSELUGO at DailyMed
Drug patent expirations by year for KOSELUGO
Drug Prices for KOSELUGO

See drug prices for KOSELUGO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KOSELUGO
Generic Entry 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:
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

SponsorPhase
Children's Hospital of PhiladelphiaPhase 2
University of Alabama at BirminghamPhase 2
Congressionally Directed Medical Research ProgramsPhase 2

See all KOSELUGO clinical trials

US Patents and Regulatory Information for KOSELUGO

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KOSELUGO is ⤷  Sign Up.

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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Hydrogen sulfate salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Hydrogen sulfate salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN)

FDA Regulatory Exclusivity protecting KOSELUGO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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)
Exclusivity Expiration: ⤷  Sign Up

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

Patent: 8696
Patent: SAL DE SULFATO DE HIDROGENO DEL ACIDO 6-(4-BROMO-2-CLORO-FENILAMINO)-7-FLUOR-3-METIL-3H-BENZOIMIDAZOL-5-CARBOXILICO.
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 06330759
Patent: Novel hydrogen sulfate salt
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0620091
Patent: sal hidrogenossulafato, método para preparo e uso do mesmo
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 34149
Patent: NOUVEAU SEL HYDROGENOSULFATE (NOVEL HYDROGEN SULFATE SALT)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1360718
Patent: Novel hydrogen sulfate salt
Estimated Expiration: ⤷  Sign Up

Patent: 2329270
Patent: Hydrogen sulfate salt
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0130663
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 14303
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 68948
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 088597
Patent: SAL DE SULFATO DE HIDRÓGENO NOVEDOSA
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 68948
Patent: NOUVEAU SEL HYDROGENOSULFATE (NOVEL HYDROGEN SULFATE SALT)
Estimated Expiration: ⤷  Sign Up

France

Patent: C1051
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 24043
Patent: NOVEL HYDROGEN SULFATE SALT
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 100046
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2224
Patent: מלח מימן גופרתי של 6-(4-ברומו-2-כלורו-פנילאמינו)-7-פלואורו-3-מתיל-h3-בנזואימידאזול-5-חומצה קרבוקסילית (2-הידרוקסי-אתוקסי)-אמיד לטיפול במחלות המטופלות ע''י עכבה של mek (Hydrogen sulfate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3h-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide for treating diseases treated by inhibition of mek)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 27723
Estimated Expiration: ⤷  Sign Up

Patent: 09521487
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 968948
Estimated Expiration: ⤷  Sign Up

Patent: 2021530
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 7733
Patent: NOVEL HYDROGEN SULFATE SALT
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 08008298
Patent: SAL DE SULFATO DE HIDROGENO NOVEDOSA. (NOVEL HYDROGEN SULFATE SALT.)
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 1139
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 9792
Patent: Novel hydrogen sulphate benzimidazole salt
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 68948
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 68948
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 18790
Patent: НОВАЯ ГИДРОСУЛЬФАТНАЯ СОЛЬ (NOVEL HYDROSULPHATE SALT)
Estimated Expiration: ⤷  Sign Up

Patent: 08129199
Patent: НОВАЯ ГИДРОСУЛЬФАТНАЯ СОЛЬ
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 843
Patent: NOVA SO VODONIK SULFATA (NOVEL HYDROGEN SULFATE SALT)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 68948
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0805705
Patent: NOVEL HYDROGEN SULFATE SALT
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1361460
Estimated Expiration: ⤷  Sign Up

Patent: 080080200
Patent: NOVEL HYDROGEN SULFATE SALT
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 21746
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 05756
Estimated Expiration: ⤷  Sign Up

Patent: 0800915
Patent: Novel hydrogen sulfate salt
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 531
Patent: НОВИЙ ГІДРОСУЛЬФАТ[НОВЫЙ ГИДРОСУЛЬФАТ (NOVEL HYDROGEN SULFATE SALT)
Estimated Expiration: ⤷  Sign Up

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
Taiwan 201031642 N3 alkylated benzimidazole derivative as MEK inhibitors ⤷  Sign Up
South Korea 20100040759 N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS ⤷  Sign Up
South Korea 100984613 ⤷  Sign Up
Iceland 2990 ⤷  Sign Up
Japan 2009521487 ⤷  Sign Up
South Africa 200805705 NOVEL HYDROGEN SULFATE SALT ⤷  Sign Up
Brazil PI0306026 composto, composição farmaceutica e uso de um composto ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KOSELUGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1968948 21C1051 France ⤷  Sign Up PRODUCT NAME: SEL DE SULFATE D'HYDROGENE DU SELUMETINIB, Y COMPRIS LES FORMES SOLVATES OU ANHYDRES DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1552 20210619
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 1990010-9 Sweden ⤷  Sign Up PRODUCT NAME: BINIMETINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES THEROF; REG. NO/DATE: EU/1/18/1315 20180924
1482932 C201930018 Spain ⤷  Sign Up 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
1968948 LUC00234 Luxembourg ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018
1482932 LUC00100 Luxembourg ⤷  Sign Up PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND 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.