Orange Book product · Brand (NDA)
SYMPROIC
NALDEMEDINE TOSYLATE
At a glance
Mar 23, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 23, 2017
9 yr 5 mo ago
Today
Patent RE46375 expires
Listed drug substance patent expiration.
Oct 05, 2026
in 4 mo
Patent RE46365 expires
Listed drug substance patent expiration.
Feb 24, 2031
in 4 yr 9 mo
Patent 9108975 expires
Listed drug substance patent expiration.
Nov 11, 2031
in 5 yr 6 mo
Patent 10952968 expires
Listed drug substance patent expiration.
May 13, 2033
in 7 yr
Patent 12350377 expires
Listed drug product patent expiration.
May 13, 2033
in 7 yr
Pharmaceutical detail
Active ingredient
NALDEMEDINE TOSYLATE
Strength
EQ 0.2MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208854
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.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE46375 | Oct 05, 2026 | in 4 mo | SubstanceProductU-1185 |
| RE46365 | Feb 24, 2031 | in 4 yr 9 mo | SubstanceProduct |
| 9108975 | Nov 11, 2031 | in 5 yr 6 mo | SubstanceProduct |
| 10952968 | May 13, 2033 | in 7 yr | SubstanceProduct |
| 12350377 | May 13, 2033 | in 7 yr | Product |
