Details for New Drug Application (NDA): 202714
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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 Pharms Amgen |
| Ingredient: | carfilzomib |
| Patents: | 4 |
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. | 76075-101 | 76075-101-21 | 1 VIAL, SINGLE-USE in 1 CARTON (76075-101-21) / 30 mL in 1 VIAL, SINGLE-USE |
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: | May 22, 2028 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| Regulatory Exclusivity Expiration: | Nov 22, 2028 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 7,417,042*PED | Patent Expiration: | Jan 20, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 202714
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-001 | Jul 20, 2012 | 7,232,818 | ⤷ Start Trial |
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | 8,207,127 | ⤷ Start Trial |
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-003 | Jun 7, 2018 | 7,232,818 | ⤷ Start Trial |
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714-002 | Jun 3, 2016 | 7,232,818 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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