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 six patents protecting this drug. Additional details are available on the LUMAKRAS profile page.
The generic ingredient in LUMAKRAS is sotorasib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sotorasib profile page.
The generic ingredient in LUMAKRAS is sotorasib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sotorasib profile page.
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: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
| Approval Date: | May 28, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH PANITUMUMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER AS DETERMINED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED PRIOR FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY | ||||||||
| 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 | ||||||||
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