Details for New Drug Application (NDA): 219878
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NDA 219878 describes BAXFENDY, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the BAXFENDY profile page.
The generic ingredient in BAXFENDY is baxdrostat. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the baxdrostat profile page.
The generic ingredient in BAXFENDY is baxdrostat. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the baxdrostat profile page.
Summary for 219878
| Tradename: | BAXFENDY |
| Applicant: | Astrazeneca Ab |
| Ingredient: | baxdrostat |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219878
Generic Entry Date for 219878*:
Constraining patent/regulatory exclusivity:
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: 219878
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BAXFENDY | baxdrostat | TABLET;ORAL | 219878 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6001 | 0310-6001-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-6001-30) |
| BAXFENDY | baxdrostat | TABLET;ORAL | 219878 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6001 | 0310-6001-95 | 7 TABLET, FILM COATED in 1 BOTTLE (0310-6001-95) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | May 15, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 15, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 9,353,081 | Patent Expiration: | Feb 4, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | May 15, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 15, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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