FDA Orange Book
Is there a generic for Voquezna Dual Pak?
Voquezna Dual Pak contains amoxicillin and 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 Dual Pak (amoxicillin and 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 Dual Pak products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, tablet, oral | 500MG;EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
NDA 215153, 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 Dual Pak patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7977488 | April 10, 2030 | Drug substance | None | 215153 |
| 9186411 | August 11, 2030 | Drug product | None | 215153 |
Voquezna Dual Pak exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 3, 2027 | 215153 |
| GAIN | Generating Antibiotic Incentives Now | May 3, 2032 | 215153 |
Questions
Is there a generic for Voquezna Dual Pak?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Voquezna Dual Pak (amoxicillin and 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 Dual Pak?
The active ingredient in Voquezna Dual Pak is amoxicillin and vonoprazan, per the FDA Orange Book.
When does the Voquezna Dual Pak patent expire?
The last patent listed for Voquezna Dual Pak 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.