FDA Orange Book

Is there a generic for Voquezna?

Voquezna contains vonoprazan. 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 Voquezna (vonoprazan). The Orange Book shows its last listed patent expires August 11, 2030 and its last listed exclusivity ends May 3, 2032.

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Voquezna products in the Orange Book

Voquezna products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oralEQ 10MG BASEMarketed (Rx)None0None
tablet, oralEQ 20MG BASEMarketed (Rx)None0None

NDA 215151, held by PHATHOM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Voquezna patents

Patents listed for Voquezna
PatentExpiresCoversUse codeNDA
7977488April 10, 2030Drug substanceNone215151
9186411August 11, 2030Drug productNone215151

Voquezna exclusivity

Exclusivity listed for Voquezna
CodeMeaningExpiresNDA
NPNew productNovember 1, 2026215151
NCENew chemical entityMay 3, 2027215151
I-948New indicationJuly 17, 2027215151
GAINGenerating Antibiotic Incentives NowMay 3, 2032215151

Voquezna NDC codes

Questions

Is there a generic for Voquezna?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Voquezna (vonoprazan). The Orange Book shows its last listed patent expires August 11, 2030 and its last listed exclusivity ends May 3, 2032.

What is the generic name for Voquezna?

The active ingredient in Voquezna is vonoprazan, per the FDA Orange Book.

When does the Voquezna patent expire?

The last patent listed for Voquezna in the Orange Book expires August 11, 2030. 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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