Orange Book product · Brand (NDA)
MODEYSO
DORDAVIPRONE HYDROCHLORIDE
At a glance
Aug 06, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 06, 2025
11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 06, 2030
in 4 yr 2 mo
Patent 9629842 expires
Listed method-of-use patent (U-4254) expiration.
Apr 30, 2032
in 5 yr 11 mo
Patent RE46290 expires
Listed method-of-use patent (U-4254) expiration.
Apr 30, 2032
in 5 yr 11 mo
Exclusivity ends · ODE-547
Orphan-drug exclusivity (7 years)
Aug 06, 2032
in 6 yr 3 mo
Patent 9265765 expires
Listed drug product patent expiration.
Jul 26, 2034
in 8 yr 3 mo
Patent 11976068 expires
Listed drug product patent expiration.
Mar 01, 2036
in 9 yr 10 mo
Patent 10172862 expires
Listed method-of-use patent (U-4254) expiration.
Jan 30, 2037
in 10 yr 9 mo
Patent 10369154 expires
Listed method-of-use patent (U-4254) expiration.
Jan 30, 2037
in 10 yr 9 mo
Patent 12102639 expires
Listed method-of-use patent (U-4254) expiration.
Jan 30, 2037
in 10 yr 9 mo
Pharmaceutical detail
Active ingredient
DORDAVIPRONE HYDROCHLORIDE
Strength
EQ 125MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 219876
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)
Aug 06, 2030
in 4 yr 2 mo
- ODE-547Orphan-drug exclusivity (7 years)
Aug 06, 2032
in 6 yr 3 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9629842 | Apr 30, 2032 | in 5 yr 11 mo | U-4254 |
| RE46290 | Apr 30, 2032 | in 5 yr 11 mo | U-4254 |
| 9265765 | Jul 26, 2034 | in 8 yr 3 mo | Product |
| 11976068 | Mar 01, 2036 | in 9 yr 10 mo | Product |
| 10172862 | Jan 30, 2037 | in 10 yr 9 mo | U-4254 |
| 10369154 | Jan 30, 2037 | in 10 yr 9 mo | U-4254 |
| 12102639 | Jan 30, 2037 | in 10 yr 9 mo | U-4254 |

