Details for New Drug Application (NDA): 215310
✉ Email this page to a colleague
NDA 215310 describes EXKIVITY, which is a drug marketed by Takeda Pharms Usa 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 EXKIVITY profile page.
The generic ingredient in EXKIVITY is mobocertinib succinate. One supplier is listed for this compound. Additional details are available on the mobocertinib succinate profile page.
The generic ingredient in EXKIVITY is mobocertinib succinate. One supplier is listed for this compound. Additional details are available on the mobocertinib succinate profile page.
Summary for 215310
| Tradename: | EXKIVITY |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | mobocertinib succinate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215310
Generic Entry Date for 215310*:
Constraining patent/regulatory exclusivity:
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: 215310
| Mechanism of Action | Cytochrome P450 3A Inducers HER1 Antagonists |
Suppliers and Packaging for NDA: 215310
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-040 | 63020-040-12 | 120 CAPSULE in 1 BOTTLE (63020-040-12) |
| EXKIVITY | mobocertinib succinate | CAPSULE;ORAL | 215310 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-040 | 63020-040-90 | 90 CAPSULE in 1 BOTTLE (63020-040-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Sep 15, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 15, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 INSERTION MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 13, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 EXON INSERTION MUTATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY | ||||||||
Complete Access Available with Subscription
