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WAINUA (AUTOINJECTOR)

NDA

EPLONTERSEN SODIUM | N217388 | ASTRAZENECA AB

2 strengths4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Expired (1)Active (3)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Apr. 1, 2026

May. 1, 2034

May. 1, 2034

Aug. 25, 2034

NCE

Dec. 21, 2028

ODE-461

Dec. 21, 2030

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

5 letters from Drugs@FDA

Date	Submission	Document
Apr 16, 2026	SUPPL -5	View Letter (PDF)
Dec 19, 2025	SUPPL -6	View Letter (PDF)
Apr 28, 2025	SUPPL -4	View Letter (PDF)
Sep 26, 2024	SUPPL -2	View Letter (PDF)
Dec 22, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)

RLD

0 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Apr 15, 2026

#001 — EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)

RLD

4 patents2 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Dec 21, 2023

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8101743	Apr 1, 2026	—	Yes	Yes	—	—
9127276	May 1, 2034	—	Yes	—	—	—
9181549	May 1, 2034	—	Yes	—	—	—
10683499	Aug 25, 2034	—	Yes	Yes		—

Exclusivities (2)

Code	Date	Status
NCE	Dec 21, 2028	Active
ODE-461	Dec 21, 2030	Active