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AMONDYS 45

NDA

CASIMERSEN | N213026 | SAREPTA THERAPEUTICS INC

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

Today

Feb. 16, 2029

Nov. 12, 2030

Nov. 12, 2030

Nov. 12, 2030

Nov. 12, 2030

NCE

Feb. 25, 2026

ODE-347

Feb. 25, 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 Amondys-45 (2023)

Total Spending

$13.6M

Total Claims

199

Beneficiaries

—

Avg Cost/Unit

$833.23

Spending Trend

$4.4M(2021)→$10.0M(2022)→$13.6M(2023)

YoY Change:+0.9%

5yr CAGR:+2.1%

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jan 8, 2026	SUPPL -16	View Letter (PDF)
Jul 15, 2024	SUPPL -8	View Letter (PDF)
Mar 24, 2023	SUPPL -5	View Letter (PDF)
Mar 1, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/2ML (50MG/ML)

RLD

5 patents2 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 25, 2021

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE48960	Feb 16, 2029	—	Yes	Yes		—
9228187	Nov 12, 2030	—	Yes	Yes	—	—
9758783	Nov 12, 2030	—	—	—		—
10287586	Nov 12, 2030	—	Yes	Yes	—	—
10781450	Nov 12, 2030	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Feb 25, 2026	Expired
ODE-347	Feb 25, 2028	Active