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VILTEPSO

NDA

VILTOLARSEN | N212154 | NIPPON SHINYAKU CO LTD

1 strength2 unique patents1 unique exclusivity

Patent Timeline

2 unique patents, 1 exclusivity by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

Today

Apr. 3, 2034

Aug. 31, 2031

ODE-280

Aug. 12, 2027

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Nippon Shinyaku.,Ltd. v. Sarepta Therapeutics, Inc. 1:2021cv01015 10 patentsviltolarsen (NS-065) / golodirsen (SRP-4053)	D. Del.	2021-07-13	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 12, 2021	SUPPL -2	View Letter (PDF)
Aug 13, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG/5ML (50MG/ML)

RLD

2 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: Aug 12, 2020

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9079934	Apr 3, 2034	—	Yes	Yes	—	—
10870676	Aug 31, 2031	—	Yes	Yes		—

Code	Date	Status
ODE-280	Aug 12, 2027	Active