FDA Orange Book
Is there a generic for Fabhalta?
Fabhalta contains iptacopan. 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 Fabhalta (iptacopan). The Orange Book shows its last listed patent expires July 15, 2041 and its last listed exclusivity ends March 20, 2032.
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Fabhalta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 218276, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Fabhalta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10093663 | July 14, 2034 | Method of use | U-4161 | 218276 |
| 10093663 | July 14, 2034 | Method of use | U-3980 | 218276 |
| 9682968 | July 14, 2034 | Drug substance, Drug product | None | 218276 |
| 12285422 | August 30, 2038 | Method of use | U-4181 | 218276 |
| 11723901 | August 30, 2038 | Method of use | U-3980 | 218276 |
| 12384758 | May 17, 2041 | Method of use | U-3980 | 218276 |
| 12384758 | May 17, 2041 | Method of use | U-4161 | 218276 |
| 11603363 | May 25, 2041 | Drug substance, Drug product | None | 218276 |
| 12453726 | July 15, 2041 | Method of use | U-4300 | 218276 |
| 11951101 | July 15, 2041 | Method of use | U-3895 | 218276 |
Fabhalta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-949 | New indication | August 7, 2027 | 218276 |
| I-963 | New indication | March 20, 2028 | 218276 |
| NCE | New chemical entity | December 5, 2028 | 218276 |
| ODE-456 | Orphan drug exclusivity | December 5, 2030 | 218276 |
| ODE-524 | Orphan drug exclusivity | March 20, 2032 | 218276 |
Fabhalta NDC codes
Questions
Is there a generic for Fabhalta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Fabhalta (iptacopan). The Orange Book shows its last listed patent expires July 15, 2041 and its last listed exclusivity ends March 20, 2032.
What is the generic name for Fabhalta?
The active ingredient in Fabhalta is iptacopan, per the FDA Orange Book.
When does the Fabhalta patent expire?
The last patent listed for Fabhalta in the Orange Book expires July 15, 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.