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REDEMPLO

NDA

PLOZASIRAN SODIUM | N219947 | ARROWHEAD PHARMACEUTICALS INC

1 strength5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Mar. 7, 2037

Sep. 10, 2038

Mar. 7, 2037

Sep. 10, 2038

Sep. 10, 2038

ODE-541

Nov. 18, 2032

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 19, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

RLD

5 patents1 exclusivity▴

SOLUTION;SUBCUTANEOUS | Approved: Nov 18, 2025

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10294474	Mar 7, 2037	—	Yes	Yes		—
10597657	Sep 10, 2038	—	Yes	Yes		—
11174481	Mar 7, 2037	—	Yes	Yes	—	—
11214801	Sep 10, 2038	—	Yes	Yes		—
12365899	Sep 10, 2038	—	Yes	Yes		—

Exclusivities (1)

Code	Date	Status
ODE-541	Nov 18, 2032	Active

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Orphan drug exclusivity for Plozasiran Sodium (REDEMPLO) was added to the Orange Book, providing seven years of regulatory exclusivity from approval.

New: New record