POLIDOCANOL - Generic Drug Details

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What are the generic drug sources for polidocanol and what is the scope of freedom to operate?

Polidocanol is the generic ingredient in two branded drugs marketed by Chemisch Fbrk Krsslr and Provensis, and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Polidocanol has ninety-seven patent family members in thirty countries.

Two suppliers are listed for this compound.

Summary for POLIDOCANOL

International Patents:	97
US Patents:	4
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	26
Patent Applications:	4,557
What excipients (inactive ingredients) are in POLIDOCANOL?	POLIDOCANOL excipients list
DailyMed Link:	POLIDOCANOL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for POLIDOCANOL

Generic Entry Date for POLIDOCANOL^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for POLIDOCANOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Assiut University	Phase 4
Johns Hopkins University	Phase 1
Massachusetts General Hospital	Phase 1

See all POLIDOCANOL clinical trials

Pharmacology for POLIDOCANOL

Drug Class	Sclerosing Agent
Mechanism of Action	Sclerosing Activity
Physiological Effect	Vascular Sclerosing Activity

Anatomical Therapeutic Chemical (ATC) Classes for POLIDOCANOL

C05BB	Sclerosing agents for local injection
C05B	ANTIVARICOSE THERAPY
C05	VASOPROTECTIVES
C	Cardiovascular system

US Patents and Regulatory Information for POLIDOCANOL

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Chemisch Fbrk Krsslr	ASCLERA	polidocanol	SOLUTION;INTRAVENOUS	021201-002	Mar 30, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-002	Dec 21, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chemisch Fbrk Krsslr	ASCLERA	polidocanol	SOLUTION;INTRAVENOUS	021201-001	Mar 30, 2010		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for POLIDOCANOL

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

International Patents for POLIDOCANOL

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Country	Patent Number	Title	Estimated Expiration
South Africa	200604366	Therapeutic foam	⤷ Sign Up
Slovenia	1701701		⤷ Sign Up
Japan	5107445		⤷ Sign Up
Canada	2546108	METHODES DE PREPARATION D'UNE MOUSSE COMPRENANT UN AGENT SCLEROSANT (METHODS OF PREPARING A FOAM COMPRISING A SCLEROSING AGENT)	⤷ Sign Up
Hong Kong	1094943	THERAPEUTIC FOAM COMPRISING A SCLEROSING SOLUTION AND A LOW QUANTITY OF GASEOUS NITROGEN	⤷ Sign Up
European Patent Office	1791519	MOUSSES THÉRAPEUTIQUES AVEC UN SCLÉROSANT ET AVEC UN AGENT AMÉLIORANT LA VISCOSITÉ, MÉTHODES POUR LEUR PRODUCTION (THERAPEUTIC FOAMS WITH A SCLEROSANT AND A VISCOSITY-IMPROVING AGENT, METHODS FOR ITS MANUFACTURING)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated 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.