FDA Orange Book · active-ingredient family
Vonoprazan fumarate
Vonoprazan fumarate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VOQUEZNA · NDA 215151
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
7
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VOQUEZNARLD×2 | PHATHOM | NDA 215151 | — | Nov 01, 2023 |
Marketing exclusivity (7)
- I-948New indication exclusivity (3 years)
Jul 17, 2027
in 1 yr 1 mo
- NCENew chemical entity exclusivity (5 years)
May 03, 2027
in 11 mo
- NPNew product exclusivity (3 years)
Nov 01, 2026
in 5 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
May 03, 2032
in 6 yr
- NCENew chemical entity exclusivity (5 years)
May 03, 2027
in 11 mo
- NPNew product exclusivity (3 years)
Nov 01, 2026
in 5 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 |
Vonoprazan fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
