FDA Orange Book
Is there a generic for Givlaari?
Givlaari contains givosiran. 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 Givlaari (givosiran). The Orange Book shows its last listed patent expires October 3, 2034 and its last listed exclusivity ends November 20, 2026.
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Givlaari products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 189MG BASE/ML (EQ 189MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 212194, 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.
Givlaari patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10131907 | August 24, 2028 | Drug substance, Drug product | U-2672 | 212194 |
| 8828956 | December 4, 2028 | Drug substance, Drug product | U-2672 | 212194 |
| 8106022 | December 12, 2029 | Drug substance, Drug product | U-2672 | 212194 |
| 9631193 | March 15, 2033 | Method of use | U-2672 | 212194 |
| 10125364 | March 15, 2033 | Drug substance, Drug product | U-2672 | 212194 |
| 9133461 | November 30, 2033 | Drug substance, Drug product | U-2672 | 212194 |
| 10119143 | October 3, 2034 | Drug substance, Drug product | U-2672 | 212194 |
| 11028392 | October 3, 2034 | Drug substance, Drug product | U-2672 | 212194 |
Givlaari exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-273 | Orphan drug exclusivity | November 20, 2026 | 212194 |
Givlaari NDC codes
Questions
Is there a generic for Givlaari?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Givlaari (givosiran). The Orange Book shows its last listed patent expires October 3, 2034 and its last listed exclusivity ends November 20, 2026.
What is the generic name for Givlaari?
The active ingredient in Givlaari is givosiran, per the FDA Orange Book.
When does the Givlaari patent expire?
The last patent listed for Givlaari in the Orange Book expires October 3, 2034. 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.