Details for New Drug Application (NDA): 218037
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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.
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 | 25682-043-04 | 4 BLISTER PACK in 1 CARTON (25682-043-04) / 42 TABLET, FILM COATED in 1 BLISTER PACK (25682-043-42) |
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 |
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: | ⤷ Sign Up | 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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