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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Veozah (2023)

Total Spending

$4.5M

Total Claims

5,869

Beneficiaries

2,837

Avg Cost/Unit

$19.21

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MOEHS IBERICA SLFEZOLINETANT

DMF 405922024

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)

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