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Last Updated: September 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205098


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NDA 205098 describes VARITHENA, which is a drug marketed by Provensis and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the VARITHENA profile page.

The generic ingredient in VARITHENA is polidocanol. Two suppliers are listed for this compound. Additional details are available on the polidocanol profile page.
Summary for 205098
Tradename:VARITHENA
Applicant:Provensis
Ingredient:polidocanol
Patents:5
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 205098
Generic Entry Date for 205098*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 205098
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098 NDA Biocompatibles, Inc. 60635-107 60635-107-01 1 POUCH in 1 CARTON (60635-107-01) > 1 KIT in 1 POUCH * 7.75 mL in 1 CANISTER (60635-007-01) * 303 mL in 1 CANISTER
VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098 NDA Biocompatibles, Inc. 60635-111 60635-111-01 1 CARTON in 1 PACKAGE (60635-111-01) > 1 POUCH in 1 CARTON > 1 KIT in 1 POUCH * 7.75 mL in 1 CANISTER (60635-007-01) * 303 mL in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength180MG/18ML (10MG/ML)
Approval Date:Nov 25, 2013TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:Jul 19, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Nov 17, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD OF INTRAVENOUS INJECTION USING ULTRASOUND GUIDANCE, ADMINISTERED VIA A SINGLE CANNULA INTO THE LUMEN OF THE TARGET INCOMPETENT TRUNK VEINS OR BY DIRECT INJECTION INTO VARICOSITIES
Patent:⤷  Free Forever TrialPatent Expiration:Nov 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE

Expired US Patents for NDA 205098

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Provensis VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098-001 Nov 25, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Provensis VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098-001 Nov 25, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Provensis VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098-001 Nov 25, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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