Orange Book product · Brand (NDA)
VERQUVO
VERICIGUAT
At a glance
Jan 19, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 19, 2021
5 yr 6 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 19, 2026
5 mo ago
Today
Exclusivity ends · D-198
New indication / change exclusivity (3 years)
Jan 21, 2029
in 2 yr 8 mo
Patent 10736896 expires
Listed drug substance patent expiration.
May 19, 2031
in 5 yr
Patent 11439642 expires
Listed method-of-use patent (U-3062) expiration.
May 19, 2031
in 5 yr
Patent 8420656 expires
Listed drug substance patent expiration.
May 19, 2031
in 5 yr
Patent 8921377 expires
Listed method-of-use patent (U-3062) expiration.
May 19, 2031
in 5 yr
Patent 9993476 expires
Listed method-of-use patent (U-3062) expiration.
May 19, 2031
in 5 yr
Patent 9604948 expires
Listed drug substance patent expiration.
Nov 26, 2032
in 6 yr 6 mo
Pharmaceutical detail
Active ingredient
VERICIGUAT
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214377
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 (2)
- NCENew chemical entity exclusivity (5 years)
Jan 19, 2026
5 mo ago
- D-198New indication / change exclusivity (3 years)
Jan 21, 2029
in 2 yr 8 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10736896 | May 19, 2031 | in 5 yr | SubstanceProduct |
| 11439642 | May 19, 2031 | in 5 yr | U-3062 |
| 8420656 | May 19, 2031 | in 5 yr | SubstanceProduct |
| 8921377 | May 19, 2031 | in 5 yr | U-3062 |
| 9993476 | May 19, 2031 | in 5 yr | U-3062 |
| 9604948 | Nov 26, 2032 | in 6 yr 6 mo | SubstanceProductU-3062 |
