oxymetazoline hydrochloride · Mayne Pharma · NDA 208552
Rhofade
Earliest generic entry, as listed
11 Jun 2035
Blocked by patent: US 10335391, US 10751325, US 11517560, US 12350255, US 9974773. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10335391 | use U-2567 | 11 Jun 2035 |
| US 10751325 | use U-2921 | 11 Jun 2035 |
| US 11517560 | use U-3494 | 11 Jun 2035 |
| US 12350255 | use U-3494 | 11 Jun 2035 |
| US 9974773 | use U-2306 | 11 Jun 2035 |
| US 8883838 | product | 1 Dec 2031 |
| US 7812049 | use U-1959 | 2 May 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
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 |
|---|---|---|---|
| 208552 · 001 · RLD | cream, topical | 1% | 11 Jun 2035 |