Details for New Drug Application (NDA): 218213
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The generic ingredient in AUGTYRO is repotrectinib. One supplier is listed for this compound. Additional details are available on the repotrectinib profile page.
Summary for 218213
Tradename: | AUGTYRO |
Applicant: | Bristol |
Ingredient: | repotrectinib |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218213
Generic Entry Date for 218213*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WITH ADENOCARCINOMA HISTOLOGY 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: 218213
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-4040 | 0003-4040-12 | 120 CAPSULE in 1 BOTTLE (0003-4040-12) |
AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-4040 | 0003-4040-60 | 60 CAPSULE in 1 BOTTLE (0003-4040-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
Approval Date: | Nov 15, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Nov 15, 2030 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WITH ADENOCARCINOMA HISTOLOGY | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 5, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 24, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) |
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