Details for New Drug Application (NDA): 216578
✉ Email this page to a colleague
NDA 216578 describes VEOZAH, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the VEOZAH profile page.
The generic ingredient in VEOZAH is fezolinetant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fezolinetant profile page.
The generic ingredient in VEOZAH is fezolinetant. There is one drug master file entry for this compound. 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:
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: 216578
| Mechanism of Action | Neurokinin 3 Receptor Antagonists |
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: | 10,836,768 | Patent Expiration: | Mar 28, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE | ||||||||
| Patent: | 8,871,761 | Patent Expiration: | Apr 4, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Complete Access Available with Subscription
