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.
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
*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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 180MG/18ML (10MG/ML) | ||||
| Approval Date: | Nov 25, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 19, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 17, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist 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: | ⤷ Sign Up | Patent Expiration: | Nov 19, 2027 | Product Flag? | Y | Substance 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 | ⤷ 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 |
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