Details for New Drug Application (NDA): 203756
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NDA 203756 describes COMETRIQ, which is a drug marketed by Exelixis and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the COMETRIQ profile page.
The generic ingredient in COMETRIQ is cabozantinib s-malate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabozantinib s-malate profile page.
The generic ingredient in COMETRIQ is cabozantinib s-malate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabozantinib s-malate profile page.
Summary for 203756
| Tradename: | COMETRIQ |
| Applicant: | Exelixis |
| Ingredient: | cabozantinib s-malate |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203756
Generic Entry Date for 203756*:
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: 203756
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 203756
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COMETRIQ | cabozantinib s-malate | CAPSULE;ORAL | 203756 | NDA | Exelixis, Inc. | 42388-011 | 42388-011-14 | 4 BLISTER PACK in 1 CARTON (42388-011-14) / 1 KIT in 1 BLISTER PACK |
| COMETRIQ | cabozantinib s-malate | CAPSULE;ORAL | 203756 | NDA | Exelixis, Inc. | 42388-012 | 42388-012-14 | 4 BLISTER PACK in 1 CARTON (42388-012-14) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Nov 29, 2012 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jan 15, 2030 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jan 15, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jan 15, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING MEDULLARY THYROID CANCER | ||||||||
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