revefenacin · Mylan Ireland Ltd · NDA 210598
Yupelri
Earliest generic entry, as listed
23 Oct 2039
Blocked by patent: US 11484531. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11484531 | use U-2440 · sets the listed date | 23 Oct 2039 |
| US 12048692 | use U-2440 | 29 Aug 2039 |
| US 12285417 | use U-2440 | 29 Aug 2039 |
| US 8541451 | drug substance | 25 Aug 2031 |
| US 10550081 | drug substance | 14 Jul 2030 |
| US 11008289 | use U-2440 | 14 Jul 2030 |
| US 11691948 | drug product | 14 Jul 2030 |
| US 11858898 | drug substance, drug product, use U-2440 | 14 Jul 2030 |
| US 9765028 | drug substance | 14 Jul 2030 |
| US 7288657 | drug substance | 31 Oct 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 218088, Lupin Inc. · 210598-001Tentative approval 15 May 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210598 · 001 · RLD | solution, inhalation | 175MCG/3ML | 23 Oct 2039 |