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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 214665


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NDA 214665 describes LUMAKRAS, which is a drug marketed by Amgen Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the LUMAKRAS profile page.

The generic ingredient in LUMAKRAS is sotorasib. One supplier is listed for this compound. Additional details are available on the sotorasib profile page.
Summary for 214665
Tradename:LUMAKRAS
Applicant:Amgen Inc
Ingredient:sotorasib
Patents:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214665
Generic Entry Date for 214665*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 214665
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUMAKRAS sotorasib TABLET;ORAL 214665 NDA Amgen Inc 55513-488 55513-488-02 2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01)
LUMAKRAS sotorasib TABLET;ORAL 214665 NDA Amgen Inc 55513-488 55513-488-24 1 BOTTLE, PLASTIC in 1 CARTON (55513-488-24) / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:May 28, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:May 28, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:May 28, 2028
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY
Patent:⤷  SubscribePatent Expiration:May 21, 2038Product Flag?YSubstance Flag?YDelist 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.