Details for New Drug Application (NDA): 218037
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NDA 218037 describes VOYDEYA, which is a drug marketed by Alexion Pharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VOYDEYA profile page.
The generic ingredient in VOYDEYA is danicopan. One supplier is listed for this compound. Additional details are available on the danicopan profile page.
The generic ingredient in VOYDEYA is danicopan. One supplier is listed for this compound. Additional details are available on the danicopan profile page.
Summary for 218037
| Tradename: | VOYDEYA |
| Applicant: | Alexion Pharms Inc |
| Ingredient: | danicopan |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218037
Generic Entry Date for 218037*:
Constraining patent/regulatory exclusivity:
TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) 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.
Pharmacology for NDA: 218037
Suppliers and Packaging for NDA: 218037
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VOYDEYA | danicopan | TABLET;ORAL | 218037 | NDA | Alexion Pharmaceuticals Inc. | 25682-043 | 25682-043-92 | 2 BOTTLE in 1 CARTON (25682-043-92) / 90 TABLET, FILM COATED in 1 BOTTLE |
| VOYDEYA | danicopan | TABLET;ORAL | 218037 | NDA | Alexion Pharmaceuticals Inc. | 25682-046 | 25682-046-92 | 1 KIT in 1 CARTON (25682-046-92) * 90 TABLET, FILM COATED in 1 BOTTLE (25682-040-90) * 90 TABLET, FILM COATED in 1 BOTTLE (25682-043-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Mar 29, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 29, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 29, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) | ||||||||
| Patent: | 12,076,319 | Patent Expiration: | Aug 2, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF EXTRAVASCULAR HEMOLYSIS (EVH) IN ADULTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AS ADD-ON THERAPY TO RAVULIZUMAB OR ECULIZUMAB | ||||||||
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