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: | 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KOSELUGO
*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 |
|---|---|
| Children's Hospital of Philadelphia | Phase 2 |
| University of Alabama at Birmingham | Phase 2 |
| Congressionally Directed Medical Research Programs | Phase 2 |
Pharmacology for KOSELUGO
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Mitogen-Activated Protein Kinase Kinase 1 Inhibitors Mitogen-Activated Protein Kinase Kinase 2 Inhibitors |
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 | ||
| >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 |
|---|---|---|---|
| Canada | 2478374 | UTILISATION DE DERIVES DE BENZIMIDAZOLE ALKYLES N3 EN TANT QU'INHIBITEURS DE MEK (N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS) | ⤷ Sign Up |
| Cyprus | 1114303 | ⤷ Sign Up | |
| Hungary | S1900011 | ⤷ 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 | 44/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: SELUMETINIB (EINSCHLIESSLICH JEGLICHE PHARMAZEUTISCHE AKZEPTABLER SALZE (INSBESONDERE HYDROGENSULFATE), ESTER, SOLVATE ODER ENANTIOMERE DAVON); REGISTRATION NO/DATE: EU/1/21/1552 (MITTEILUNG) 20210619 |
| 1482932 | 14/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924 |
| 1482932 | 19C1014 | France | ⤷ Sign Up | PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1315 20180924 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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