Viewing data from:

VEOZAH

NDA

FEZOLINETANT | N216578 | ASTELLAS PHARMA US INC

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

Today

Apr. 4, 2031

Mar. 28, 2034

Mar. 28, 2034

Mar. 28, 2034

NCE

May. 12, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause NCT04003155	Phase 3	Completed	Astellas Pharma Global Development, Inc.	527	2019-07-11 → 2021-08-11
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2 NCT04003142	Phase 3	Completed	Astellas Pharma Global Development, Inc.	501	2019-07-10 → 2021-04-23
A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants NCT04277624	Phase 1	Completed	Astellas Pharma Global Development, Inc.	22	2020-02-20 → 2021-02-26
A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause NCT04003389	Phase 3	Completed	Astellas Pharma Global Development, Inc.	1,831	2019-07-10 → 2022-01-04
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause NCT04234204	Phase 3	Completed	Astellas Pharma China, Inc.	302	2020-03-17 → 2022-04-20
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)NCT03192176	Phase 2	Completed	Astellas Pharma Global Development, Inc.	356	2017-07-19 → 2018-09-19

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$18.59

per ea

Lowest NADAC/Unit

$18.59

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00469266030VEOZAH 45 MG TABLET	$18.59	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$412.50

Highest Price

$412.50

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00469-2660-30VEOZAH 45MG TAB	$412.50	FSS	Astellas Pharma U.S., Inc.	09/29/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Veozah (2024)

Total Spending

$38.4M

Total Claims

52,827

Beneficiaries

13,805

Avg Cost/Unit

$17.77

Spending Trend

$4.5M(2023)→$38.4M(2024)

YoY Change:-7.5%

5yr CAGR:-7.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MOEHS IBERICA SLFEZOLINETANT

DMF 405922024

SHANDONG LONCOM PHARMACEUTICAL CO LTDFEZOLINETANT

DMF 436102026

MSN LIFE SCIENCES PRIVATE LTDFEZOLINETANT

DMF 438222026

AMI LIFESCIENCES PRIVATE LTDFEZOLINETANT

DMF 438432026

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 18, 2024	SUPPL -4	View Letter (PDF)
Sep 3, 2024	SUPPL -3	View Letter (PDF)
May 15, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 45MG

RLD

4 patents1 exclusivity▴

TABLET;ORAL | Approved: May 12, 2023

Patents (4) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8871761	Apr 4, 2031	—	Yes	—	—	—
9422299	Mar 28, 2034	—	Yes	Yes		—
9987274	Mar 28, 2034	—	—	—		—
10836768	Mar 28, 2034	—	—	—		—

Exclusivities (1)

Code	Date	Status
NCE	May 12, 2028	Active