Orange Book product · Brand (NDA)
OXLUMO
LUMASIRAN SODIUM
At a glance
Nov 23, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 23, 2020
5 yr 8 mo ago
Today
Exclusivity ends · ODE-339
Orphan-drug exclusivity (7 years)
Nov 23, 2027
in 1 yr 5 mo
Patent 10131907 expires
Listed drug substance patent expiration.
Aug 24, 2028
in 2 yr 3 mo
Patent 8828956 expires
Listed drug substance patent expiration.
Dec 04, 2028
in 2 yr 6 mo
Exclusivity ends · ODE-415
Orphan-drug exclusivity (7 years)
Oct 06, 2029
in 3 yr 4 mo
Patent 8106022 expires
Listed drug substance patent expiration.
Dec 12, 2029
in 3 yr 6 mo
Patent 10435692 expires
Listed method-of-use patent (U-2995) expiration.
Dec 26, 2034
in 8 yr 8 mo
Patent 10465195 expires
Listed drug substance patent expiration.
Dec 26, 2034
in 8 yr 8 mo
Patent 10487330 expires
Listed drug substance patent expiration.
Dec 26, 2034
in 8 yr 8 mo
Patent 11060093 expires
Listed drug substance patent expiration.
Dec 26, 2034
in 8 yr 8 mo
Patent 9828606 expires
Listed drug substance patent expiration.
Dec 26, 2034
in 8 yr 8 mo
Patent 10612024 expires
Listed drug substance patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 10612027 expires
Listed drug substance patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 11401517 expires
Listed drug substance patent expiration.
Aug 14, 2035
in 9 yr 3 mo
Patent 10478500 expires
Listed drug substance patent expiration.
Oct 09, 2035
in 9 yr 5 mo
Patent 11446380 expires
Listed drug substance patent expiration.
Oct 09, 2035
in 9 yr 5 mo
Patent 11261447 expires
Listed drug substance patent expiration.
Nov 20, 2038
in 12 yr 7 mo
Pharmaceutical detail
Active ingredient
LUMASIRAN SODIUM
Strength
EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 214103
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)
- ODE-339Orphan-drug exclusivity (7 years)
Nov 23, 2027
in 1 yr 5 mo
- ODE-415Orphan-drug exclusivity (7 years)
Oct 06, 2029
in 3 yr 4 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10131907 | Aug 24, 2028 | in 2 yr 3 mo | SubstanceProductU-2995 |
| 8828956 | Dec 04, 2028 | in 2 yr 6 mo | SubstanceProductU-2995 |
| 8106022 | Dec 12, 2029 | in 3 yr 6 mo | SubstanceProductU-2995 |
| 10435692 | Dec 26, 2034 | in 8 yr 8 mo | U-2995 |
| 10465195 | Dec 26, 2034 | in 8 yr 8 mo | SubstanceProductU-2995 |
| 10487330 | Dec 26, 2034 | in 8 yr 8 mo | SubstanceProductU-2995 |
| 11060093 | Dec 26, 2034 | in 8 yr 8 mo | SubstanceProductU-2995 |
| 9828606 | Dec 26, 2034 | in 8 yr 8 mo | SubstanceProduct |
| 10612024 | Aug 14, 2035 | in 9 yr 3 mo | SubstanceProductU-2995 |
| 10612027 | Aug 14, 2035 | in 9 yr 3 mo | SubstanceProductU-2995 |
| 11401517 | Aug 14, 2035 | in 9 yr 3 mo | SubstanceProductU-2995 |
| 10478500 | Oct 09, 2035 | in 9 yr 5 mo | SubstanceProductU-2995 |
| 11446380 | Oct 09, 2035 | in 9 yr 5 mo | SubstanceProduct |
| 11261447 | Nov 20, 2038 | in 12 yr 7 mo | SubstanceProductU-2995 |
