Details for New Drug Application (NDA): 215192
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NDA 215192 describes VAFSEO, which is a drug marketed by Akebia and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the VAFSEO profile page.
The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this compound. Additional details are available on the vadadustat profile page.
The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this compound. Additional details are available on the vadadustat profile page.
Summary for 215192
| Tradename: | VAFSEO |
| Applicant: | Akebia |
| Ingredient: | vadadustat |
| Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215192
Generic Entry Date for 215192*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;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.
Suppliers and Packaging for NDA: 215192
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VAFSEO | vadadustat | TABLET;ORAL | 215192 | NDA | Akebia Therapeutics, Inc. | 59922-641 | 59922-641-60 | 1 BOTTLE in 1 CARTON (59922-641-60) / 60 TABLET, FILM COATED in 1 BOTTLE |
| VAFSEO | vadadustat | TABLET;ORAL | 215192 | NDA | Akebia Therapeutics, Inc. | 59922-642 | 59922-642-60 | 1 BOTTLE in 1 CARTON (59922-642-60) / 60 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Mar 27, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,149,842 | Patent Expiration: | Nov 14, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 11,065,237 | Patent Expiration: | Nov 14, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS | ||||||||
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