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Last Updated: May 18, 2024

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KOSELUGO Drug Patent Profile


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Which patents cover Koselugo, and when can generic versions of Koselugo launch?

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: 11
Patent Applications: 2,416
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
AstraZenecaPhase 1
Merck Sharp & Dohme Corp.Phase 1
National Cancer Institute (NCI)Phase 3

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 ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Hydrogen sulfate salt
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Hydrogen sulfate salt
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 06330759
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0620091
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 34149
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1360718
Estimated Expiration: ⤷  Try a Trial

Patent: 2329270
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0130663
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 14303
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 68948
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 088597
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 68948
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1051
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 24043
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 100046
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2224
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 27723
Estimated Expiration: ⤷  Try a Trial

Patent: 09521487
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 968948
Estimated Expiration: ⤷  Try a Trial

Patent: 2021530
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7733
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 08008298
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 1139
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9792
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 68948
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 68948
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 18790
Estimated Expiration: ⤷  Try a Trial

Patent: 08129199
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 843
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 68948
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0805705
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1361460
Estimated Expiration: ⤷  Try a Trial

Patent: 080080200
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 21746
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 05756
Estimated Expiration: ⤷  Try a Trial

Patent: 0800915
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 531
Estimated Expiration: ⤷  Try a Trial

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
European Patent Office 2130537 Dérivés de benzimidazole d'alkylat N3 en tant qu'inhibiteurs de Mek (N3 alkylated benzimidazole derivatives as mek inhibitors) ⤷  Try a Trial
Hong Kong 1153139 作為 抑制劑的 烷基化苯並咪唑衍生物 (N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS MEK N3) ⤷  Try a Trial
Denmark 1482932 ⤷  Try a Trial
European Patent Office 1968948 NOUVEAU SEL HYDROGENOSULFATE (NOVEL HYDROGEN SULFATE SALT) ⤷  Try a Trial
European Patent Office 2271321 COMPOSITION PHARMACEUTIQUE 271 (PHARMACEUTICAL COMPOSITION 271) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KOSELUGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1482932 C01482932/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BINIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66907 01.11.2019
1482932 122019000022 Germany ⤷  Try a Trial PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920
1968948 C202130063 Spain ⤷  Try a Trial 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 132021000000194 Italy ⤷  Try a Trial PRODUCT NAME: SELUMETINIB (INCLUSI SUOI SALI (IN PARTICOLARE IDROGENOSOLFATO), ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(KOSELUGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1552, 20210619
1482932 300974 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
>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.