FDA Orange Book · active-ingredient family
Lumasiran sodium
Lumasiran sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:OXLUMO · NDA 214103
1
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
2
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXLUMORLD | ALNYLAM PHARMS INC | NDA 214103 | — | Nov 23, 2020 |
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 |
| 11060093 | Dec 26, 2034 | in 8 yr 8 mo | SubstanceProductU-2995 |
| 10465195 | Dec 26, 2034 | in 8 yr 8 mo | SubstanceProductU-2995 |
| 10435692 | Dec 26, 2034 | in 8 yr 8 mo | U-2995 |
| 10487330 | Dec 26, 2034 | in 8 yr 8 mo | SubstanceProductU-2995 |
| 9828606 | Dec 26, 2034 | in 8 yr 8 mo | SubstanceProduct |
| 11401517 | Aug 14, 2035 | in 9 yr 3 mo | SubstanceProductU-2995 |
| 10612024 | Aug 14, 2035 | in 9 yr 3 mo | SubstanceProductU-2995 |
| 10612027 | 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 |
Lumasiran sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
