Details for New Drug Application (NDA): 216578
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The generic ingredient in VEOZAH is fezolinetant. One supplier is listed for this compound. Additional details are available on the fezolinetant profile page.
Summary for 216578
Tradename: | VEOZAH |
Applicant: | Astellas |
Ingredient: | fezolinetant |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216578
Generic Entry Date for 216578*:
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: 216578
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VEOZAH | fezolinetant | TABLET;ORAL | 216578 | NDA | Astellas Pharma US, Inc. | 0469-2460 | 0469-2460-28 | 4 CARTON in 1 TRAY (0469-2460-28) / 1 BOTTLE in 1 CARTON (0469-2460-07) / 7 TABLET, FILM COATED in 1 BOTTLE |
VEOZAH | fezolinetant | TABLET;ORAL | 216578 | NDA | Astellas Pharma US, Inc. | 0469-2660 | 0469-2660-30 | 1 BOTTLE in 1 CARTON (0469-2660-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 45MG | ||||
Approval Date: | May 12, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 12, 2028 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 28, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE WITH MENOPAUSE | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 4, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? |
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