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
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 |


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