Details for New Drug Application (NDA): 216340
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NDA 216340 describes KRAZATI, which is a drug marketed by Bristol 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 KRAZATI profile page.
The generic ingredient in KRAZATI is adagrasib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the adagrasib profile page.
The generic ingredient in KRAZATI is adagrasib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the adagrasib profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216340
Generic Entry Date for 216340*:
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: 216340
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KRAZATI | adagrasib | TABLET;ORAL | 216340 | NDA | Mirati Therapeutics, Inc | 80739-812 | 80739-812-12 | 1 BOTTLE in 1 CARTON (80739-812-12) / 120 TABLET, COATED in 1 BOTTLE |
| KRAZATI | adagrasib | TABLET;ORAL | 216340 | NDA | Mirati Therapeutics, Inc | 80739-812 | 80739-812-18 | 1 BOTTLE in 1 CARTON (80739-812-18) / 180 TABLET, COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Dec 12, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 12, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 12, 2029 | ||||||||
| 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: | 10,689,377 | Patent Expiration: | May 17, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented 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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