FDA Orange Book
Is there a generic for Onpattro?
Onpattro contains patisiran. 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 Onpattro (patisiran). The Orange Book shows its last listed patent expires August 27, 2035 and its last listed exclusivity ends January 13, 2026.
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Onpattro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 10MG BASE/5ML (EQ 2MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 210922, 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.
Onpattro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8642076 | October 3, 2027 | Drug product | None | 210922 |
| 8822668 | April 15, 2029 | Drug product | U-2378 | 210922 |
| 9364435 | April 15, 2029 | Drug product | U-2378 | 210922 |
| 11141378 | April 15, 2029 | Drug product | None | 210922 |
| 8492359 | April 15, 2029 | Drug product | None | 210922 |
| 8058069 | April 15, 2029 | Drug product | None | 210922 |
| 9234196 | October 20, 2029 | Drug product | U-2378 | 210922 |
| 8741866 | October 20, 2029 | Method of use | U-2378 | 210922 |
| 10240152 | October 20, 2029 | Drug substance, Drug product | U-2378 | 210922 |
| 8802644 | October 21, 2030 | Drug product | U-2378 | 210922 |
| 8158601 | November 10, 2030 | Drug product | U-2378 | 210922 |
| 8168775 | August 10, 2032 | Drug substance, Drug product | U-2378 | 210922 |
| 11079379 | August 27, 2035 | Drug substance, Drug product | U-2378 | 210922 |
Onpattro exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-270 | Miscellaneous | January 13, 2026 | 210922 |
Onpattro NDC codes
Questions
Is there a generic for Onpattro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Onpattro (patisiran). The Orange Book shows its last listed patent expires August 27, 2035 and its last listed exclusivity ends January 13, 2026.
What is the generic name for Onpattro?
The active ingredient in Onpattro is patisiran, per the FDA Orange Book.
When does the Onpattro patent expire?
The last patent listed for Onpattro in the Orange Book expires August 27, 2035. 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.