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Polidocanol - Generic Drug Details

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What are the generic drug sources for polidocanol and what is the scope of polidocanol 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 fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Polidocanol has one hundred and eighty-five patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for polidocanol

International Patents:	185
US Patents:	14
Tradenames:	2
Applicants:	2
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	30
Clinical Trials:	16
Patent Applications:	1,817
Formulation / Manufacturing:	see details
DailyMed Link:	polidocanol at DailyMed

Pharmacology for polidocanol

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

Synonyms for polidocanol

2-[2-[2-[2-[2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethanol

3,6,9,12,15,18,21,24,27-Nonaoxanonatriacontan-1-ol

3055-99-0

9043-30-5

AC1LCVC1

AEO-9

Aethoxy-sklerol

AKOS028108701

AN-6543

API0005051

C12E9

C13493

CAS-3055-99-0

CHEBI:46859

CHEMBL1231723

CTK1C2495

D05ZPL

DB06811

Detergent Screening Solution 23/Fluka kit no 66317

DODECYL NONA ETHYLENE GLYCOL ETHER

Dodecyl nonaethylene glycol ether

Dodecylnonaglycol

Dodecylnonaoxyethylene glycol monoether

DSSTox_CID_19721

DSSTox_GSID_39721

DSSTox_RID_79436

DTXSID5039721

EINECS 221-284-4

genapol X 080

genapol X-080

Genapol X080

GK9185

J-018016

KS-00000Y0K

laureth-9

LP016773

Macrogol 9 lauryl ether

MFCD00043375

MFCD00163738

MolPort-003-935-762

NCGC00166290-01

NCGC00166290-02

NCGC00166290-03

Nonaethylene glycol monododecyl ether

Nonaethylene glycol monododecyl ether, nonionic surfactant

nonaethylene glycol monolauryl ether

Nonaethyleneglycol monododecyl ether 1 mM solution

Nonaethyleneglycol monododecyl ether solution

NONAETHYLENEGLYCOLMONODODECYLETHER

Oligoethylene glycol monoalkyl ether

ONJQDTZCDSESIW-UHFFFAOYSA-N

PEG-9 lauryl ether

POELE

Poly(oxy-1,2-ethanediyl),a-isotridecyl-w-hydroxy-

Polydocanol

Polyethylene glycol 450 lauryl ether

Polyethylene glycol monoalkyl ether

Polyethylene glycol monoisotridecyl ether

Polyoxyethylen-9-laurylether

Polyoxyethylene (9) lauryl ether

Polyoxyethylene 9 lauryl ether

Polyoxyl 9 lauryl ether

SCHEMBL25580

SR-01000944476

SR-01000944476-1

Tox21_112394

Tox21_112394_1

ZINC8214662

US Patents and Regulatory Information for polidocanol

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
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes			Y	Y
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes			Y
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes			Y	Y

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Expired US Patents for polidocanol

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

Non-Orange Book US Patents for polidocanol

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,091,801	Generation of therapeutic microfoam
7,763,269	Therapeutic foam
8,048,439	Therapeutic foam
9,545,378	Aerosol valve

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International Patents for polidocanol

Country	Document Number	Estimated Expiration
United Kingdom	0321210
Cyprus	1110513
Austria	338807
Hong Kong	1094943