DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 021938
NDA 021938 describes SUTENT, which is a drug marketed by Cppi Cv and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SUTENT profile page.
The generic ingredient in SUTENT is sunitinib malate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sunitinib malate profile page.
The generic ingredient in SUTENT is sunitinib malate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sunitinib malate profile page.
Summary for 021938
| Tradename: | SUTENT |
| Applicant: | Cppi Cv |
| Ingredient: | sunitinib malate |
| Patents: | 3 |
| Therapeutic Class: | Antineoplastics |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021938
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 021938
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUTENT | sunitinib malate | CAPSULE;ORAL | 021938 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0550 | N | 0069-0550-38 |
| SUTENT | sunitinib malate | CAPSULE;ORAL | 021938 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0770 | N | 0069-0770-38 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 12.5MG BASE | ||||
| Approval Date: | Jan 26, 2006 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 16, 2020 | ||||||||
| Regulatory Exclusivity Use: | ADJUVANT TREATMENT OF ADULT PATIENTS AT HIGH RISK OF RECURRENT RENAL CELL CARCINOMA (RCC) FOLLOWING NEPHRECTOMY | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Feb 15, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | ADJUVANT TREATMENT OF ADULT PATIENTS AT HIGH RISK OF RECURRENT RCC FOLLOWING NEPHRECTOMY | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Feb 15, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH SUNITINIB | ||||||||
Complete Access Available with Subscription
