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VARITHENA

NDA

POLIDOCANOL | N205098 | BOSTON SCIENTIFIC CORP

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

2032

Today

7814943

Nov. 19, 2027

9480652

May. 12, 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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

AGNO PHARMAPOLIDOCANOL

DMF 376372024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
May 26, 2026	SUPPL -51	View Letter (PDF)
Aug 22, 2019	SUPPL -31	View Letter (PDF)
Dec 27, 2017	SUPPL -26	View Letter (PDF)
Jun 24, 2016	SUPPL -18	View Letter (PDF)
Jan 9, 2015	SUPPL -5	View Letter (PDF)
Jun 27, 2014	SUPPL -1	View Letter (PDF)
Nov 27, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 180MG/18ML (10MG/ML)

RLD

2 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Nov 25, 2013

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7814943	Nov 19, 2027	—	—	Yes		—
9480652	May 12, 2032	—	—	Yes	—	—

#002 — 77.5MG/7.75ML (10MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Dec 21, 2017

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

VARITHENA (polidocanol) applicant changed from PROVENSIS to BOSTON SCITFC for NDA 205098.

Old: PROVENSIS

New: BOSTON SCITFC

MODIFIEDApplicant Full Name7/1/2026

Applicant for Varithena (polidocanol) NDA 205098 changed from Provensis Ltd to Boston Scientific Corp.

Old: PROVENSIS LTD

New: BOSTON SCIENTIFIC CORP