Details for New Drug Application (NDA): 213756
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NDA 213756 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 213756
| Tradename: | KOSELUGO |
| Applicant: | Astrazeneca |
| Ingredient: | selumetinib sulfate |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213756
Generic Entry Date for 213756*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION 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.
Pharmacology for NDA: 213756
Suppliers and Packaging for NDA: 213756
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0610 | 0310-0610-28 | 28 CAPSULE in 1 BOTTLE (0310-0610-28) |
| KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0610 | 0310-0610-60 | 60 CAPSULE in 1 BOTTLE (0310-0610-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Apr 10, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 10, 2027 | ||||||||
| Regulatory Exclusivity Use: | 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) | ||||||||
| Regulatory Exclusivity Expiration: | Apr 10, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 10, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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