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Last Updated: August 10, 2022

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 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

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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
Drug patent expirations by year for KOSELUGO
Drug Prices for KOSELUGO

See drug prices for KOSELUGO

DrugPatentWatch® Estimated Generic Entry Opportunity 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 four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KOSELUGO is See Plans and Pricing.

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

N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Hydrogen sulfate salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Hydrogen sulfate salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-001 Apr 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca KOSELUGO selumetinib sulfate CAPSULE;ORAL 213756-002 Apr 10, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 06330759
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0620091
Estimated Expiration: See Plans and Pricing

Canada

Patent: 34149
Estimated Expiration: See Plans and Pricing

China

Patent: 1360718
Estimated Expiration: See Plans and Pricing

Patent: 2329270
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0130663
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14303
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 68948
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 088597
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 68948
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 24043
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 100046
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2224
Estimated Expiration: See Plans and Pricing

Japan

Patent: 27723
Estimated Expiration: See Plans and Pricing

Patent: 09521487
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 2021530
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7733
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08008298
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1139
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9792
Estimated Expiration: See Plans and Pricing

Poland

Patent: 68948
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 68948
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 18790
Estimated Expiration: See Plans and Pricing

Patent: 08129199
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 843
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 68948
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0805705
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1361460
Estimated Expiration: See Plans and Pricing

Patent: 080080200
Estimated Expiration: See Plans and Pricing

Spain

Patent: 21746
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 05756
Estimated Expiration: See Plans and Pricing

Patent: 0800915
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 531
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
China 1874768 N3 alkylated benzimidazole derivatives as MEK inhibitors See Plans and Pricing
Taiwan 201031642 N3 alkylated benzimidazole derivative as MEK inhibitors See Plans and Pricing
Argentina 045738 DERIVADOS DE BENCIMIDAZOL N3 ALQUILADOS COMO INHIBIDORES DE MEK See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KOSELUGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1482932 LUC00100 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: SELUMETINIB (EINSCHLIESSLICH PHARMAZEUTISCH AKZEPTABLER SALZE (INSBESONDERE HYDROGENSULFAT), ESTER, SOLVATE ODER ENANTIOMERE DAVON); REGISTRATION NO/DATE: EU/1/21/1552 20210617
>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.