FDA Orange Book

Is there a generic for Vivjoa?

Vivjoa contains oteseconazole. 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 Vivjoa (oteseconazole). The Orange Book shows its last listed patent expires March 17, 2036 and its last listed exclusivity ends April 26, 2032.

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Vivjoa products in the Orange Book

Vivjoa products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral150MGMarketed (Rx)None0None

NDA 215888, held by MYCOVIA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Vivjoa patents

Patents listed for Vivjoa
PatentExpiresCoversUse codeNDA
8754227April 22, 2031Method of useU-3366215888
8236962April 22, 2031Drug substance, Drug productNone215888
11247981May 9, 2033Method of useU-3366215888
9840492March 17, 2036Drug substance, Drug productNone215888
10414751March 17, 2036Drug substance, Drug productNone215888

Vivjoa exclusivity

Exclusivity listed for Vivjoa
CodeMeaningExpiresNDA
NCENew chemical entityApril 26, 2027215888
GAINGenerating Antibiotic Incentives NowApril 26, 2032215888

Vivjoa NDC codes

Questions

Is there a generic for Vivjoa?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Vivjoa (oteseconazole). The Orange Book shows its last listed patent expires March 17, 2036 and its last listed exclusivity ends April 26, 2032.

What is the generic name for Vivjoa?

The active ingredient in Vivjoa is oteseconazole, per the FDA Orange Book.

When does the Vivjoa patent expire?

The last patent listed for Vivjoa in the Orange Book expires March 17, 2036. 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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