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Last Updated: March 29, 2024

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 four 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:4
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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. 60635-118 60635-118-01 1 POUCH in 1 CARTON (60635-118-01) / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER
VARITHENA polidocanol SOLUTION;INTRAVENOUS 205098 NDA Biocompatibles, Inc. 60635-133 60635-133-01 1 CARTON in 1 PACKAGE (60635-133-01) / 1 POUCH in 1 CARTON / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 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:⤷  Try a 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:⤷  Try a 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
Patent:⤷  Try a TrialPatent Expiration:Sep 9, 2024Product Flag?YSubstance Flag?Delist Request?

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.