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Last Updated: November 22, 2024

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 one NDA. It is available from one supplier. There are five 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.
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.

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:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Apr 10, 2020TE: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 UpPatent Expiration:Mar 26, 2029Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.