FDA Orange Book

Is there a generic for Varithena?

Varithena contains polidocanol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

No. The Orange Book lists no active FDA-approved generic (ANDA) for Varithena (polidocanol). The Orange Book shows its last listed patent expires May 12, 2032.

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Varithena products in the Orange Book

Varithena products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, intravenous180MG/18ML (10MG/ML)Marketed (Rx)None0None
solution, intravenous77.5MG/7.75ML (10MG/ML)DiscontinuedNone0None

NDA 205098, held by BOSTON SCIENTIFIC CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Varithena patents

Patents listed for Varithena
PatentExpiresCoversUse codeNDA
7814943November 19, 2027Drug productU-1461205098
9480652May 12, 2032Drug productNone205098

Questions

Is there a generic for Varithena?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Varithena (polidocanol). The Orange Book shows its last listed patent expires May 12, 2032.

What is the generic name for Varithena?

The active ingredient in Varithena is polidocanol, per the FDA Orange Book.

When does the Varithena patent expire?

The last patent listed for Varithena in the Orange Book expires May 12, 2032. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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