FDA Orange Book
Is there a generic for Oxlumo?
Oxlumo contains lumasiran. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Oxlumo (lumasiran). The Orange Book shows its last listed patent expires May 29, 2041 and its last listed exclusivity ends October 6, 2029.
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Oxlumo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 214103, held by ALNYLAM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Oxlumo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10131907 | August 24, 2028 | Drug substance, Drug product | U-2995 | 214103 |
| 8828956 | December 4, 2028 | Drug substance, Drug product | U-2995 | 214103 |
| 8106022 | December 12, 2029 | Drug substance, Drug product | U-2995 | 214103 |
| 11060093 | December 26, 2034 | Drug substance, Drug product | U-2995 | 214103 |
| 10465195 | December 26, 2034 | Drug substance, Drug product | U-2995 | 214103 |
| 10435692 | December 26, 2034 | Method of use | U-2995 | 214103 |
| 10487330 | December 26, 2034 | Drug substance, Drug product | U-2995 | 214103 |
| 9828606 | December 26, 2034 | Drug substance, Drug product | None | 214103 |
| 11401517 | August 14, 2035 | Drug substance, Drug product | U-2995 | 214103 |
| 10612024 | August 14, 2035 | Drug substance, Drug product | U-2995 | 214103 |
| 10612027 | August 14, 2035 | Drug substance, Drug product | U-2995 | 214103 |
| 10478500 | October 9, 2035 | Drug substance, Drug product | U-2995 | 214103 |
| 11446380 | October 9, 2035 | Drug substance, Drug product | None | 214103 |
| 11261447 | November 20, 2038 | Drug substance, Drug product | U-2995 | 214103 |
| 12723247 | May 29, 2041 | Drug substance, Drug product | U-2995 | 214103 |
Oxlumo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-339 | Orphan drug exclusivity | November 23, 2027 | 214103 |
| ODE-415 | Orphan drug exclusivity | October 6, 2029 | 214103 |
Oxlumo NDC codes
Questions
Is there a generic for Oxlumo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Oxlumo (lumasiran). The Orange Book shows its last listed patent expires May 29, 2041 and its last listed exclusivity ends October 6, 2029.
What is the generic name for Oxlumo?
The active ingredient in Oxlumo is lumasiran, per the FDA Orange Book.
When does the Oxlumo patent expire?
The last patent listed for Oxlumo in the Orange Book expires May 29, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.