Orange Book product · Brand (NDA)
VOQUEZNA DUAL PAK
AMOXICILLIN; VONOPRAZAN FUMARATE
At a glance
May 03, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 03, 2022
4 yr 2 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 03, 2027
in 11 mo
Patent 7977488 expires
Listed drug substance patent expiration.
Apr 10, 2030
in 3 yr 10 mo
Patent 9186411 expires
Listed drug product patent expiration.
Aug 11, 2030
in 4 yr 2 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
May 03, 2032
in 6 yr
Pharmaceutical detail
Active ingredient
AMOXICILLIN; VONOPRAZAN FUMARATE
Strength
500MG;EQ 20MG BASE
Dosage form
CAPSULE, TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215153
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
May 03, 2027
in 11 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
May 03, 2032
in 6 yr
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7977488 | Apr 10, 2030 | in 3 yr 10 mo | Substance |
| 9186411 | Aug 11, 2030 | in 4 yr 2 mo | Product |
