Details for New Drug Application (NDA): 213756
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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: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213756
Generic Entry Date for 213756*:
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) 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 | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 26, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? |
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