erdafitinib · Janssen Biotech · NDA 212018
Balversa
Earliest generic entry, as listed · earliest of 3 marketed strengths
2 Feb 2038
Blocked by patent: US 11077106. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
18 Orange Book listing rows for 9 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11077106 | use U-3196, U-3808 | 2 Feb 2038 |
| US 11077106 listing row | use U-3196 · sets the listed date | 2 Feb 2038 |
| US 11077106 listing row | use U-3808 · sets the listed date | 2 Feb 2038 |
| US 10478494 | use U-3902 | 13 Aug 2036 |
| US 12678498 | use U-4584 | 13 Jun 2036 |
| US 10898482 | drug product, use U-2518, U-3065, U-3066, U-3067, U-3805, U-3806, U-3807 | 9 Feb 2036 |
| US 10898482 listing row | drug product, use U-2518 | 9 Feb 2036 |
| US 10898482 listing row | drug product, use U-3065 | 9 Feb 2036 |
| US 10898482 listing row | drug product, use U-3066 | 9 Feb 2036 |
| US 10898482 listing row | drug product, use U-3067 | 9 Feb 2036 |
| US 10898482 listing row | drug product, use U-3805 | 9 Feb 2036 |
| US 10898482 listing row | drug product, use U-3806 | 9 Feb 2036 |
| US 10898482 listing row | drug product, use U-3807 | 9 Feb 2036 |
| US 11684620 | use U-3805, U-3806, U-3807 | 9 Feb 2036 |
| US 11684620 listing row | use U-3805 | 9 Feb 2036 |
| US 11684620 listing row | use U-3806 | 9 Feb 2036 |
| US 11684620 listing row | use U-3807 | 9 Feb 2036 |
| US 12037644 | use U-3972 | 18 Oct 2035 |
| US 9902714 | drug product | 26 Mar 2035 |
| US 8895601 | drug substance, drug product | 12 Apr 2033 |
| US 9464071 | use U-3805 | 28 Apr 2031 |
Exclusivities · 1 unexpired
| I-930 | new indication (3 years) | 19 Jan 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic tentatively approved · ANDA 218578, Natco Pharma Ltd · 212018-001Tentative approval 2 Feb 2026Detected 25 Oct 2026Historical import
- Exclusivity expires within 90 days I-930 · 212018-003Exclusivity expires 19 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days I-930 · 212018-002Exclusivity expires 19 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days I-930 · 212018-001Exclusivity expires 19 Jan 2027Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212018 · 001 · RLD | tablet, oral | 3MG | 2 Feb 2038 |
| 212018 · 002 · RLD | tablet, oral | 4MG | 2 Feb 2038 |
| 212018 · 003 · RLD | tablet, oral | 5MG | 2 Feb 2038 |