Details for New Drug Application (NDA): 220613
NDA 220613 describes OMCAZIO, which is a drug marketed by Handa Oncol 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 OMCAZIO profile page.
The generic ingredient in OMCAZIO is cabozantinib laurylsulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cabozantinib laurylsulfate profile page.
The generic ingredient in OMCAZIO is cabozantinib laurylsulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cabozantinib laurylsulfate profile page.
Summary for 220613
| Tradename: | OMCAZIO |
| Applicant: | Handa Oncol |
| Ingredient: | cabozantinib laurylsulfate |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220613
Generic Entry Date for 220613*:
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: 220613
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 220613
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMCAZIO | cabozantinib laurylsulfate | CAPSULE;ORAL | 220613 | NDA | Handa Pharma | 17201-011 | 17201-011-30 | 1 BOTTLE in 1 CARTON (17201-011-30) / 30 CAPSULE in 1 BOTTLE |
| OMCAZIO | cabozantinib laurylsulfate | CAPSULE;ORAL | 220613 | NDA | Handa Pharma | 17201-012 | 17201-012-30 | 1 BOTTLE in 1 CARTON (17201-012-30) / 30 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 11.5MG BASE | ||||
| Approval Date: | Sep 3, 2026 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 13, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADVANCED RENAL CELL CARCINOMA | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 13, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 30, 2044 | Product Flag? | Substance Flag? | Delist Request? | |||
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