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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 Pharms 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.
US ANDA Litigation and 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 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 111 |
| Patent Applications: | 209 |
| Drug Prices: | Drug price information for KOSELUGO |
| DailyMed Link: | KOSELUGO at DailyMed |
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.
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 Pharms | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Pharms | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-002 | Apr 10, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Pharms | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20100040759 | Start Trial |
| Japan | 5498546 | Start Trial |
| Israel | 173935 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for KOSELUGO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1482932 | 2019C/510 | Belgium | Start Trial | PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924 |
| 1482932 | 122019000022 | Germany | Start Trial | PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
| 1482932 | 334 8-2019 | Slovakia | Start Trial | PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
