Details for New Drug Application (NDA): 205098
✉ Email this page to a colleague
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.
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 |
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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 180MG/18ML (10MG/ML) | ||||
| Approval Date: | Nov 25, 2013 | TE: | RLD: | Yes | |||||
| Patent: | 7,731,986 | 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: | 7,814,943 | 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 | ||||||||
| Patent: | 8,122,917 | Patent Expiration: | Sep 9, 2024 | Product Flag? | Y | Substance 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 | 8,122,917 | ⤷ Subscribe |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | RE40640 | ⤷ Subscribe |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | 7,357,336 | ⤷ Subscribe |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | 7,842,283 | ⤷ Subscribe |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | 6,572,873 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
