Orange Book product · Brand (NDA)
CONTEPO
FOSFOMYCIN DISODIUM
At a glance
Oct 22, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 22, 2025
8 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Oct 22, 2028
in 2 yr 5 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Oct 22, 2033
in 7 yr 5 mo
Patent 10086006 expires
Listed method-of-use patent (U-4332) expiration.
Oct 12, 2034
in 8 yr 5 mo
Patent 9345717 expires
Listed method-of-use patent (U-4332) expiration.
Oct 27, 2034
in 8 yr 6 mo
Patent 11541064 expires
Listed method-of-use patent (U-4331) expiration.
Jan 30, 2039
in 12 yr 10 mo
Pharmaceutical detail
Active ingredient
FOSFOMYCIN DISODIUM
Strength
EQ 6GM BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 212271
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
Marketing exclusivity (2)
- NPNew product exclusivity (3 years)
Oct 22, 2028
in 2 yr 5 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Oct 22, 2033
in 7 yr 5 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10086006 | Oct 12, 2034 | in 8 yr 5 mo | U-4332 |
| 9345717 | Oct 27, 2034 | in 8 yr 6 mo | U-4332 |
| 11541064 | Jan 30, 2039 | in 12 yr 10 mo | U-4331 |
