FDA Orange Book
Is there a generic for Balversa?
Balversa contains erdafitinib. 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 Balversa (erdafitinib). The Orange Book shows its last listed patent expires February 2, 2038 and its last listed exclusivity ends January 19, 2027.
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Balversa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 3MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 4MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 212018, held by JANSSEN BIOTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Balversa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9464071 | April 28, 2031 | Method of use | U-3805 | 212018 |
| 8895601 | April 12, 2033 | Drug substance, Drug product | None | 212018 |
| 9902714 | March 26, 2035 | Drug product | None | 212018 |
| 12037644 | October 18, 2035 | Method of use | U-3972 | 212018 |
| 10898482 | February 9, 2036 | Drug product | U-3066 | 212018 |
| 10898482 | February 9, 2036 | Drug product | U-3065 | 212018 |
| 10898482 | February 9, 2036 | Drug product | U-3067 | 212018 |
| 10898482 | February 9, 2036 | Drug product | U-2518 | 212018 |
| 10898482 | February 9, 2036 | Drug product | U-3805 | 212018 |
| 10898482 | February 9, 2036 | Drug product | U-3807 | 212018 |
| 10898482 | February 9, 2036 | Drug product | U-3806 | 212018 |
| 11684620 | February 9, 2036 | Method of use | U-3805 | 212018 |
| 11684620 | February 9, 2036 | Method of use | U-3807 | 212018 |
| 11684620 | February 9, 2036 | Method of use | U-3806 | 212018 |
| 12678498 | June 13, 2036 | Method of use | U-4584 | 212018 |
| 10478494 | August 13, 2036 | Method of use | U-3902 | 212018 |
| 11077106 | February 2, 2038 | Method of use | U-3196 | 212018 |
| 11077106 | February 2, 2038 | Method of use | U-3808 | 212018 |
Balversa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-930 | New indication | January 19, 2027 | 212018 |
Balversa NDC codes
Questions
Is there a generic for Balversa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Balversa (erdafitinib). The Orange Book shows its last listed patent expires February 2, 2038 and its last listed exclusivity ends January 19, 2027.
What is the generic name for Balversa?
The active ingredient in Balversa is erdafitinib, per the FDA Orange Book.
When does the Balversa patent expire?
The last patent listed for Balversa in the Orange Book expires February 2, 2038. 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.