Orange Book product · Brand (NDA)
DIFICID
FIDAXOMICIN
At a glance
Jan 24, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 24, 2020
6 yr 6 mo ago
Today
Exclusivity ends · ODE-367
Orphan-drug exclusivity (7 years)
Jan 24, 2027
in 7 mo
Patent 7906489 expires
Listed method-of-use patent (U-2741) expiration.
Mar 04, 2027
in 9 mo
Patent 7378508 expires
Listed drug substance patent expiration.
Jul 31, 2027
in 1 yr 2 mo
Patent 7863249 expires
Listed drug product patent expiration.
Jul 31, 2027
in 1 yr 2 mo
Patent 8859510 expires
Listed method-of-use patent (U-2741) expiration.
Jul 31, 2027
in 1 yr 2 mo
Patent 7906489*PED expires
Listed listed patent expiration.
Sep 04, 2027
in 1 yr 3 mo
Patent 7378508*PED expires
Listed listed patent expiration.
Jan 31, 2028
in 1 yr 8 mo
Patent 7863249*PED expires
Listed listed patent expiration.
Jan 31, 2028
in 1 yr 8 mo
Patent 8859510*PED expires
Listed listed patent expiration.
Jan 31, 2028
in 1 yr 8 mo
Patent 9808530 expires
Listed drug product patent expiration.
May 28, 2034
in 8 yr 1 mo
Patent 9808530*PED expires
Listed listed patent expiration.
Nov 28, 2034
in 8 yr 7 mo
Pharmaceutical detail
Active ingredient
FIDAXOMICIN
Strength
40MG/ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 213138
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 (1)
- ODE-367Orphan-drug exclusivity (7 years)
Jan 24, 2027
in 7 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7906489 | Mar 04, 2027 | in 9 mo | U-2741 |
| 7378508 | Jul 31, 2027 | in 1 yr 2 mo | SubstanceProduct |
| 7863249 | Jul 31, 2027 | in 1 yr 2 mo | Product |
| 8859510 | Jul 31, 2027 | in 1 yr 2 mo | U-2741 |
| 7906489*PED | Sep 04, 2027 | in 1 yr 3 mo | |
| 7378508*PED | Jan 31, 2028 | in 1 yr 8 mo | |
| 7863249*PED | Jan 31, 2028 | in 1 yr 8 mo | |
| 8859510*PED | Jan 31, 2028 | in 1 yr 8 mo | |
| 9808530 | May 28, 2034 | in 8 yr 1 mo | Product |
| 9808530*PED | Nov 28, 2034 | in 8 yr 7 mo |
