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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. 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. 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. Additional details are available on the carfilzomib profile page.
Summary for 202714
| Tradename: | KYPROLIS |
| Applicant: | Onyx Therap |
| Ingredient: | carfilzomib |
| Patents: | 11 |
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: | 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: | Start Trial | Patent Expiration: | Apr 14, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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