Orange Book product · Brand (NDA)
DIFICID
FIDAXOMICIN
At a glance
May 27, 2011
Approved
Brand (NDA)
Application
AB
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 27, 2011
15 yr 3 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-319) expiration.
Mar 04, 2027
in 9 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 substance patent expiration.
Jul 31, 2027
in 1 yr 2 mo
Patent 8859510 expires
Listed method-of-use patent (U-319) 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
Pharmaceutical detail
Active ingredient
FIDAXOMICIN
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 201699
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-319 |
| 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 | SubstanceProduct |
| 8859510 | Jul 31, 2027 | in 1 yr 2 mo | U-319 |
| 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 |
