Details for New Drug Application (NDA): 202714
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NDA 202714 describes KYPROLIS, which is a drug marketed by Onyx Therap and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and three Paragraph IV challenges. Additional details are available on the KYPROLIS profile page.
The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.
The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.
Summary for 202714
| Tradename: | KYPROLIS |
| Applicant: | Onyx Therap |
| Ingredient: | carfilzomib |
| Patents: | 12 |
Pharmacology for NDA: 202714
| Mechanism of Action | Proteasome Inhibitors |
Suppliers and Packaging for NDA: 202714
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714 | NDA | Onyx Pharmaceuticals, Inc. | 76075-101 | 76075-101-01 | 1 VIAL, SINGLE-USE in 1 CARTON (76075-101-01) / 30 mL in 1 VIAL, SINGLE-USE |
| KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714 | NDA | Onyx Pharmaceuticals, Inc. | 76075-102 | 76075-102-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-102-01) / 15 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 60MG/VIAL | ||||
| Approval Date: | Jul 20, 2012 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Aug 20, 2023 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY IN COMBINATION WITH DARATUMUMAB AND DEXAMETHASONE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 14, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 20, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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