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Last Updated: November 22, 2024

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.
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:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 29, 2024TE: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 UpPatent Expiration:Aug 2, 2038Product 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.