vibegron · Sumitomo Pharma Am · NDA 213006
Gemtesa
Earliest generic entry, as listed
6 Jul 2042
Blocked by patent: US 12357636. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
6 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12357636 | use U-4219 · sets the listed date | 6 Jul 2042 |
| US 12102638 | use U-3045 | 22 Mar 2040 |
| US 8247415 | drug substance, drug product, use U-3045, U-4219 | 23 Dec 2034 |
| US 8247415 listing row | drug substance, drug product, use U-3045 | 23 Dec 2034 |
| US 8247415 listing row | drug substance, drug product, use U-4219 | 23 Dec 2034 |
| US 12180219 | drug substance, drug product | 12 Mar 2034 |
| US 8653260 | drug substance | 2 Apr 2029 |
Exclusivities · 1 unexpired
| I-955 | new indication (3 years) | 18 Dec 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213006 · 001 · RLD | tablet, oral | 75MG | 6 Jul 2042 |