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 two 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: | 2 |
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: | 7,814,943 | 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: | 9,480,652 | Patent Expiration: | May 12, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 77.5MG/7.75ML (10MG/ML) | ||||
| Approval Date: | Dec 21, 2017 | TE: | RLD: | Yes | |||||
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 | 7,842,282 | ⤷ Get Started Free |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | 6,572,873 | ⤷ Get Started Free |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | 7,357,336 | ⤷ Get Started Free |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | RE40640 | ⤷ Get Started Free |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | 7,604,185 | ⤷ Get Started Free |
| Provensis | VARITHENA | polidocanol | SOLUTION;INTRAVENOUS | 205098-001 | Nov 25, 2013 | 8,734,833 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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