Details for New Drug Application (NDA): 219713
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NDA 219713 describes IBTROZI, which is a drug marketed by Nuvation and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the IBTROZI profile page.
The generic ingredient in IBTROZI is taletrectinib adipate. One supplier is listed for this compound. Additional details are available on the taletrectinib adipate profile page.
The generic ingredient in IBTROZI is taletrectinib adipate. One supplier is listed for this compound. Additional details are available on the taletrectinib adipate profile page.
Summary for 219713
| Tradename: | IBTROZI |
| Applicant: | Nuvation |
| Ingredient: | taletrectinib adipate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219713
Generic Entry Date for 219713*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
Pharmacology for NDA: 219713
| Mechanism of Action | Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors |
Suppliers and Packaging for NDA: 219713
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBTROZI | taletrectinib adipate | CAPSULE;ORAL | 219713 | NDA | Nuvation Bio Inc. | 84651-200 | 84651-200-93 | 3 BOTTLE in 1 CARTON (84651-200-93) / 30 CAPSULE in 1 BOTTLE (84651-200-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jun 11, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 11, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 3, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 3, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) | ||||||||
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