Orange Book product · Brand (NDA)
NOXAFIL
POSACONAZOLE
At a glance
Mar 13, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 13, 2014
12 yr 5 mo ago
Today
Exclusivity ends · ODE-355
Orphan-drug exclusivity (7 years)
Jun 17, 2028
in 2 yr
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Jan 27, 2029
in 2 yr 8 mo
Patent 10117951 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 8410077 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9750822 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9358297 expires
Listed drug product patent expiration.
Jun 24, 2031
in 5 yr 1 mo
Patent 9358297 expires
Listed drug product patent expiration.
Jun 24, 2031
in 5 yr 1 mo
Patent 9358297 expires
Listed drug product patent expiration.
Jun 24, 2031
in 5 yr 1 mo
Patent 9358297 expires
Listed drug product patent expiration.
Jun 24, 2031
in 5 yr 1 mo
Patent 9023790 expires
Listed drug product patent expiration.
Jul 04, 2031
in 5 yr 1 mo
Patent 9023790 expires
Listed drug product patent expiration.
Jul 04, 2031
in 5 yr 1 mo
Patent 9023790 expires
Listed drug product patent expiration.
Jul 04, 2031
in 5 yr 1 mo
Patent 9023790 expires
Listed drug product patent expiration.
Jul 04, 2031
in 5 yr 1 mo
Patent 9023790 expires
Listed drug product patent expiration.
Jul 04, 2031
in 5 yr 1 mo
Patent 9493582 expires
Listed drug product patent expiration.
Feb 27, 2033
in 6 yr 10 mo
Pharmaceutical detail
Active ingredient
POSACONAZOLE
Strength
300MG/16.7ML (18MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 205596
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2021NOXAFIL POWDERMIX KITBrand (NDA)
NDA 214770 · MSD MERCK CO
- 2013NOXAFILBrand (NDA)
NDA 205053 · MERCK SHARP DOHME
- 2006NOXAFILBrand (NDA)
NDA 022003 · SCHERING
- 2025POSACONAZOLEGeneric (ANDA)
ANDA 217720 · QILU PHARM HAINAN
- 2025POSACONAZOLEGeneric (ANDA)
ANDA 218434 · MSN
- 2024POSACONAZOLEGeneric (ANDA)
ANDA 219057 · ASPIRO
- 2024POSACONAZOLEGeneric (ANDA)
ANDA 217119 · AUROBINDO PHARMA
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 214842 · EUGIA PHARMA
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 209983 · FRESENIUS KABI USA
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 217553 · GLAND
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 211500 · MYLAN LABS LTD
- 2023POSACONAZOLEGeneric (ANDA)
ANDA 216488 · I 3 PHARMS
Marketing exclusivity (2)
- ODE-355Orphan-drug exclusivity (7 years)
Jun 17, 2028
in 2 yr
- NPPNew patient population exclusivity (3 years)
Jan 27, 2029
in 2 yr 8 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10117951 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 8410077 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 9750822 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 9358297 | Jun 24, 2031 | in 5 yr 1 mo | ProductU-3171 |
| 9358297 | Jun 24, 2031 | in 5 yr 1 mo | ProductU-4415 |
| 9358297 | Jun 24, 2031 | in 5 yr 1 mo | ProductU-4416 |
| 9358297 | Jun 24, 2031 | in 5 yr 1 mo | ProductU-3160 |
| 9023790 | Jul 04, 2031 | in 5 yr 1 mo | ProductU-3171 |
| 9023790 | Jul 04, 2031 | in 5 yr 1 mo | ProductU-4415 |
| 9023790 | Jul 04, 2031 | in 5 yr 1 mo | ProductU-4416 |
| 9023790 | Jul 04, 2031 | in 5 yr 1 mo | ProductU-1698 |
| 9023790 | Jul 04, 2031 | in 5 yr 1 mo | ProductU-3160 |
| 9493582 | Feb 27, 2033 | in 6 yr 10 mo | Product |
