Orange Book product · Brand (NDA)
VOQUEZNA
VONOPRAZAN FUMARATE
At a glance
Nov 01, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 01, 2023
2 yr 8 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Nov 01, 2026
in 5 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 03, 2027
in 11 mo
Exclusivity ends · I-948
New indication exclusivity (3 years)
Jul 17, 2027
in 1 yr 1 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
VONOPRAZAN FUMARATE
Strength
EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 215151
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (4)
- NPNew product exclusivity (3 years)
Nov 01, 2026
in 5 mo
- NCENew chemical entity exclusivity (5 years)
May 03, 2027
in 11 mo
- I-948New indication exclusivity (3 years)
Jul 17, 2027
in 1 yr 1 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 |
