Details for New Drug Application (NDA): 219943
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NDA 219943 describes KOSELUGO, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the KOSELUGO profile page.
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.
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.
Summary for 219943
| Tradename: | KOSELUGO |
| Applicant: | Astrazeneca |
| Ingredient: | selumetinib sulfate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219943
Generic Entry Date for 219943*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
GRANULE;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.
Pharmacology for NDA: 219943
Suppliers and Packaging for NDA: 219943
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KOSELUGO | selumetinib sulfate | GRANULE;ORAL | 219943 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0635 | 0310-0635-60 | 60 GRANULE in 1 BOTTLE (0310-0635-60) |
| KOSELUGO | selumetinib sulfate | GRANULE;ORAL | 219943 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0640 | 0310-0640-60 | 60 GRANULE in 1 BOTTLE (0310-0640-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Sep 10, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 10, 2027 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
| Regulatory Exclusivity Expiration: | Sep 10, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Mar 13, 2026 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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