naftifine hydrochloride · Legacy · NDA 019356, 019599, 204286
Naftin
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 Jan 2033
1 of 2 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 10166205, US 10166206, US 10695303, US 10729667, US 8778365, US 9161914.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10166205 | product | 31 Jan 2033 |
| US 10166206 | product | 31 Jan 2033 |
| US 10695303 | product | 31 Jan 2033 |
| US 10729667 | product | 31 Jan 2033 |
| US 8778365 | product | 31 Jan 2033 |
| US 9161914 | use U-540 | 31 Jan 2033 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019356 · 001 · RLD · discontinued | gel, topical | 1% | open |
| 019599 · 001 · RLD · discontinued | cream, topical | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019599 · 002 · RLD | cream, topical | 2% | open |
| 204286 · 001 · RLD | gel, topical | 2% | 31 Jan 2033 |