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KOSELUGO Drug 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-five patent family members in thirty-eight 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: | 155 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 2 |
| Patent Applications: | 2,715 |
| 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 |
US Patents and Regulatory Information for KOSELUGO
| 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 | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-002 | Apr 10, 2020 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | Get Started Free | Get Started Free | Y | Y | Get Started Free | ||
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-002 | Apr 10, 2020 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 200407129 | Get Started Free |
| Dominican Republic | P2011000109 | Get Started Free |
| Russian Federation | 2006109600 | Get Started Free |
| Australia | 2003218157 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KOSELUGO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1482932 | C20190010 00281 | Estonia | Get Started Free | PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018 |
| 1482932 | PA2019007,C1482932 | Lithuania | Get Started Free | PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
| 1482932 | 122019000022 | Germany | Get Started Free | PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
| 1482932 | C201930018 | Spain | Get Started Free | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
