Orange Book product · Brand (NDA)
RELISTOR
METHYLNALTREXONE BROMIDE
At a glance
Sep 27, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 27, 2010
15 yr 11 mo ago
Today
Patent 12303592 expires
Listed drug product patent expiration.
Aug 03, 2027
in 1 yr 2 mo
Patent 12303592 expires
Listed drug product patent expiration.
Aug 03, 2027
in 1 yr 2 mo
Patent 8420663 expires
Listed method-of-use patent (U-1185) expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 8822490 expires
Listed drug product patent expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9180125 expires
Listed drug product patent expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9492445 expires
Listed drug product patent expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 8247425 expires
Listed method-of-use patent (U-1185) expiration.
Dec 31, 2030
in 4 yr 7 mo
Pharmaceutical detail
Active ingredient
METHYLNALTREXONE BROMIDE
Strength
8MG/0.4ML (8MG/0.4ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 021964
Product number
002
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 (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12303592 | Aug 03, 2027 | in 1 yr 2 mo | ProductU-4197 |
| 12303592 | Aug 03, 2027 | in 1 yr 2 mo | ProductU-4198 |
| 8420663 | Sep 30, 2029 | in 3 yr 4 mo | U-1185 |
| 8822490 | Sep 30, 2029 | in 3 yr 4 mo | ProductU-1185 |
| 9180125 | Sep 30, 2029 | in 3 yr 4 mo | ProductU-1185 |
| 9492445 | Sep 30, 2029 | in 3 yr 4 mo | ProductU-1185 |
| 8247425 | Dec 31, 2030 | in 4 yr 7 mo | U-1185 |
