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VYONDYS 53

NDA

GOLODIRSEN | N211970 | SAREPTA THERAPEUTICS INC

1 strength1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

2027

2028

Today

RE47691

Jun. 28, 2028

ODE-280

Dec. 12, 2026

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 Vyondys-53 (2023)

Total Spending

$3.5M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$817.72

Spending Trend

$3.6M(2020)→$2.7M(2021)→$4.2M(2022)→$3.5M(2023)

YoY Change:-3.4%

5yr CAGR:-0.8%

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
Jul 2, 2024	SUPPL -10	View Letter (PDF)
Jul 2, 2024	SUPPL -11	View Letter (PDF)
Feb 16, 2021	SUPPL -2	View Letter (PDF)
Dec 13, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/2ML (50MG/ML)

RLD

1 patent1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: Dec 12, 2019

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE47691	Jun 28, 2028	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
ODE-280	Dec 12, 2026	< 1 year