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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 patent protection?
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-nine patent family members in thirty-nine countries.
Two suppliers are listed for this compound.
Summary for polidocanol
| International Patents: | 189 |
| US Patents: | 14 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 42 |
| Clinical Trials: | 22 |
| Patent Applications: | 3,040 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | polidocanol at DailyMed |
Recent Clinical Trials for polidocanol
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of the Republic, Uruguay | Phase 4 |
| Centro Cardiovascular Universitario | Phase 4 |
| Hospital de Clínicas Dr. Manuel Quintela | Phase 4 |
Pharmacology for polidocanol
| Drug Class | Sclerosing Agent |
| Mechanism of Action | Sclerosing Activity |
| Physiological Effect | Vascular Sclerosing Activity |
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 | Start Trial | Start Trial | Start Trial | ||||
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-002 | Dec 21, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | Start Trial | Start Trial |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | Start Trial | Start Trial |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | Start Trial | Start Trial |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | Start Trial | Start Trial |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | Start Trial | Start Trial |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for polidocanol
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 200200022 | Start Trial |
| European Patent Office | 1701701 | Start Trial |
| Germany | 60127290 | Start Trial |
| Germany | 602004024925 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0072821 | Start Trial |
| Cyprus | 1115389 | Start Trial |
| >Country | >Patent Number | >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.
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