posaconazole · Schering · NDA 022003, 205053, 205596
Noxafil
Earliest generic entry, as listed
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 6 unexpired
13 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9493582 | drug product | 27 Feb 2033 |
| US 9023790 | drug product, use U-1698, U-3160, U-3171, U-4415, U-4416 | 4 Jul 2031 |
| US 9023790 listing row | drug product, use U-1698 | 4 Jul 2031 |
| US 9023790 listing row | drug product, use U-3160 | 4 Jul 2031 |
| US 9023790 listing row | drug product, use U-3171 | 4 Jul 2031 |
| US 9023790 listing row | drug product, use U-4415 | 4 Jul 2031 |
| US 9023790 listing row | drug product, use U-4416 | 4 Jul 2031 |
| US 9358297 | drug product, use U-3160, U-3171, U-4415, U-4416 | 24 Jun 2031 |
| US 9358297 listing row | drug product, use U-3160 | 24 Jun 2031 |
| US 9358297 listing row | drug product, use U-3171 | 24 Jun 2031 |
| US 9358297 listing row | drug product, use U-4415 | 24 Jun 2031 |
| US 9358297 listing row | drug product, use U-4416 | 24 Jun 2031 |
| US 10117951 | drug product | 13 Mar 2029 |
| US 8410077 | drug product | 13 Mar 2029 |
| US 9750822 | drug product | 13 Mar 2029 |
Exclusivities · 2 unexpired
| NPP | new patient population | 27 Jan 2029 |
| ODE-355 | orphan drug (7 years) | 17 Jun 2028 |
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 approved · ANDA 213331, Apotex · 205053-001Approved 29 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022003 · 001 · RLD | suspension, oral | 40MG/ML | open |
| 205053 · 001 · RLD · discontinued | tablet, delayed release, oral | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 27 Jan 2029 |
| 205596 · 001 · RLD · discontinued | solution, intravenous | 300MG/16.7ML (18MG/ML) | 27 Feb 2033 |