Orange Book product · Brand (NDA)
VYKAT XR
DIAZOXIDE CHOLINE
At a glance
Mar 26, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 26, 2025
1 yr 3 mo ago
Today
Patent 7572789 expires
Listed drug substance patent expiration.
Dec 20, 2026
in 6 mo
Exclusivity ends · NP
New product exclusivity (3 years)
Mar 26, 2028
in 1 yr 10 mo
Patent 7799777 expires
Listed drug substance patent expiration.
Mar 05, 2029
in 2 yr 9 mo
Exclusivity ends · ODE-532
Orphan-drug exclusivity (7 years)
May 26, 2032
in 6 yr
Patent 12178823 expires
Listed method-of-use patent (U-4167) expiration.
Nov 12, 2035
in 9 yr 6 mo
Patent 12343348 expires
Listed method-of-use patent (U-4211) expiration.
Nov 12, 2035
in 9 yr 6 mo
Patent 12419895 expires
Listed method-of-use patent (U-4275) expiration.
Nov 12, 2035
in 9 yr 6 mo
Patent 9757384 expires
Listed method-of-use patent (U-4167) expiration.
Nov 12, 2035
in 9 yr 6 mo
Pharmaceutical detail
Active ingredient
DIAZOXIDE CHOLINE
Strength
25MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 216665
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)
- NPNew product exclusivity (3 years)
Mar 26, 2028
in 1 yr 10 mo
- ODE-532Orphan-drug exclusivity (7 years)
May 26, 2032
in 6 yr
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7572789 | Dec 20, 2026 | in 6 mo | SubstanceProduct |
| 7799777 | Mar 05, 2029 | in 2 yr 9 mo | Substance |
| 12178823 | Nov 12, 2035 | in 9 yr 6 mo | U-4167 |
| 12343348 | Nov 12, 2035 | in 9 yr 6 mo | U-4211 |
| 12419895 | Nov 12, 2035 | in 9 yr 6 mo | U-4275 |
| 9757384 | Nov 12, 2035 | in 9 yr 6 mo | U-4167 |
