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Details for New Drug Application (NDA): 021938
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NDA 021938 describes SUTENT, which is a drug marketed by Cppi Cv and is included in one NDA. It is available from two suppliers. 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 eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.
The generic ingredient in SUTENT is sunitinib malate. There are eight drug master file entries for this compound. Two suppliers are 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 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 021938
Generic Entry Date for 021938*:
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: 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 | 0069-0550-38 | 28 CAPSULE in 1 BOTTLE (0069-0550-38) |
| SUTENT | sunitinib malate | CAPSULE;ORAL | 021938 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0770 | 0069-0770-38 | 28 CAPSULE in 1 BOTTLE (0069-0770-38) |
Paragraph IV (Patent) Challenges for 021938
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SUTENT | CAPSULE;ORAL | sunitinib malate | 021938 | 2010-01-26 |
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 | ||||||||
| Regulatory Exclusivity Expiration: | May 16, 2021 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 15, 2021 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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