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Details for New Drug Application (NDA): 202714
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 eleven 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: | 11 |
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 |
Paragraph IV (Patent) Challenges for 202714
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KYPROLIS | POWDER;INTRAVENOUS | carfilzomib | 202714 | 2018-11-28 |
| KYPROLIS | POWDER;INTRAVENOUS | carfilzomib | 202714 | 2017-10-05 |
| KYPROLIS | POWDER;INTRAVENOUS | carfilzomib | 202714 | 2016-07-20 |
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: | Sep 28, 2021 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF A ONCE WEEKLY DOSING REGIMEN FOR CARFILZOMIB IN COMBINATION WITH DEXAMETHASONE FOR PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 21, 2019 | ||||||||
| Regulatory Exclusivity Use: | AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 21, 2019 | ||||||||
| Regulatory Exclusivity Use: | REVISED INDICATION FOR USE IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY. | ||||||||
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