Orange Book product · Brand (NDA)
ATTRUBY
ACORAMIDIS HYDROCHLORIDE
At a glance
Nov 22, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 22, 2024
1 yr 7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 22, 2029
in 3 yr 6 mo
Patent 10398681 expires
Listed drug product patent expiration.
May 05, 2031
in 4 yr 11 mo
Patent 10842777 expires
Listed method-of-use patent (U-4046) expiration.
May 05, 2031
in 4 yr 11 mo
Patent 8877795 expires
Listed drug product patent expiration.
May 05, 2031
in 4 yr 11 mo
Patent 9169214 expires
Listed drug product patent expiration.
May 05, 2031
in 4 yr 11 mo
Patent 9642838 expires
Listed drug substance patent expiration.
May 05, 2031
in 4 yr 11 mo
Patent 9913826 expires
Listed method-of-use patent (U-4046) expiration.
May 05, 2031
in 4 yr 11 mo
Exclusivity ends · ODE-506
Orphan-drug exclusivity (7 years)
Nov 22, 2031
in 5 yr 6 mo
Patent 10513497 expires
Listed drug substance patent expiration.
Feb 16, 2038
in 11 yr 10 mo
Patent 11919865 expires
Listed method-of-use patent (U-4046) expiration.
Feb 16, 2038
in 11 yr 10 mo
Patent 11058668 expires
Listed method-of-use patent (U-4046) expiration.
Mar 22, 2039
in 12 yr 11 mo
Patent 12070449 expires
Listed method-of-use patent (U-4046) expiration.
Mar 22, 2039
in 12 yr 11 mo
Patent 11260047 expires
Listed drug product patent expiration.
Aug 16, 2039
in 13 yr 4 mo
Patent 12005043 expires
Listed drug product patent expiration.
Aug 16, 2039
in 13 yr 4 mo
Patent 12539290 expires
Listed drug product patent expiration.
Aug 16, 2039
in 13 yr 4 mo
Pharmaceutical detail
Active ingredient
ACORAMIDIS HYDROCHLORIDE
Strength
EQ 356MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216540
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)
Nov 22, 2029
in 3 yr 6 mo
- ODE-506Orphan-drug exclusivity (7 years)
Nov 22, 2031
in 5 yr 6 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10398681 | May 05, 2031 | in 4 yr 11 mo | Product |
| 10842777 | May 05, 2031 | in 4 yr 11 mo | U-4046 |
| 8877795 | May 05, 2031 | in 4 yr 11 mo | Product |
| 9169214 | May 05, 2031 | in 4 yr 11 mo | ProductU-4046 |
| 9642838 | May 05, 2031 | in 4 yr 11 mo | SubstanceProduct |
| 9913826 | May 05, 2031 | in 4 yr 11 mo | U-4046 |
| 10513497 | Feb 16, 2038 | in 11 yr 10 mo | Substance |
| 11919865 | Feb 16, 2038 | in 11 yr 10 mo | U-4046 |
| 11058668 | Mar 22, 2039 | in 12 yr 11 mo | U-4046 |
| 12070449 | Mar 22, 2039 | in 12 yr 11 mo | U-4046 |
| 11260047 | Aug 16, 2039 | in 13 yr 4 mo | Product |
| 12005043 | Aug 16, 2039 | in 13 yr 4 mo | ProductU-4046 |
| 12539290 | Aug 16, 2039 | in 13 yr 4 mo | Product |
