brimonidine tartrate · Galderma Labs Lp · NDA 204708
Mirvaso
Earliest generic entry, as listed
13 Jun 2031
Blocked by patent: US 10201517, US 8053427, US 8163725.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10201517 | product | 13 Jun 2031 |
| US 8053427 | product, use U-1428 | 13 Jun 2031 |
| US 8163725 | product | 13 Jun 2031 |
| US 8513247 | product, use U-1428 | 25 Mar 2031 |
| US 8513249 | product, use U-1428 | 25 Mar 2031 |
| US 9861631 | use U-1428 | 25 Mar 2031 |
| US 9861632 | use U-1428 | 25 Mar 2031 |
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
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 |
|---|---|---|---|
| 204708 · 001 · RLD | gel, topical | EQ 0.33% BASE | 13 Jun 2031 |