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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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Olsson Frank Weeda Terman Matz PC FDA-2015-P-2854 · 5 docket documents Provensis Ltd., a company that manufactures Varithena for treating varicose veins, filed this citizen petition requesting that FDA's Center for Devices and Radiological Health withdraw approval of Premarket Approval Number P140018 for Covidien's VenaSeal Closure System. Provensis argues that VenaSea	Other	2015-08-12	Open	Olsson Frank Weeda Terman Matz PC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

21 trials from ClinicalTrials.gov, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")NCT04258761	Phase 2	Completed	10xBio, LLC	15	2019-10-10 → 2022-08-31
Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease NCT03791775	Phase 2	Completed	Societa Italiana di Chirurgia ColoRettale	183	2019-01-02 → 2020-06-02
Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence NCT01072877	Phase 3	Completed	Boston Scientific Corporation	279	2010-12 → 2012-11
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins NCT00928421	Phase 2	Completed	Boston Scientific Corporation	16	2009-06 → 2010-01
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities NCT01197833	Phase 3	Completed	Boston Scientific Corporation	117	2010-09 → 2012-12
COMFORT: A Multicenter, Open-label, Randomized, Crossover Study NCT02462720	Phase 4	Completed	Boston Scientific Corporation	35	2015-05 → 2016-03
Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins NCT02054325	Phase 4	Completed	UPECLIN HC FM Botucatu Unesp	106	2012-09 → 2014-12
Polidocanol Versus Glucose Treatment of Telangiectasia Trial NCT02657252	Phase 4	Completed	UPECLIN HC FM Botucatu Unesp	115	2015-01 → 2016-11
The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy NCT00377910	Phase 4	Completed	Northern Orthopaedic Division, Denmark	48	2008-03 → 2009-01
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)NCT01428076	Phase 1	Completed	Boston Scientific Corporation	21	2011-08 → 2012-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$2320.08

Highest Price

$3050.50

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60635-0118-01VARITHENA 180MG/18ML	$3050.50	FSS	Boston Scientific Corporation DBA Boston Scientific	08/31/2027
60635-0118-01VARITHENA 180MG/18ML	$2320.08	Big4	Boston Scientific Corporation DBA Boston Scientific	08/31/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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) · 1 use code

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