FDA Orange Book · active-ingredient family
Fidaxomicin
Fidaxomicin is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIFICID · NDA 213138
2
Brand (NDA)
3
Generics (ANDA)
10
Listed patents
2
Exclusivity periods
Brand (NDA) products · for suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIFICIDRLD | CUBIST PHARMS LLC | NDA 213138 | — | Jan 24, 2020 | |
| DIFICIDRLD | CUBIST PHARMS LLC | NDA 201699 | AB | May 27, 2011 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FIDAXOMICIN | APOTEX | ANDA 219559 | AB | Feb 02, 2026 | |
| FIDAXOMICIN | TORRENT | ANDA 220374 | AB | Jan 27, 2026 | |
| FIDAXOMICIN | ACTAVIS LABS FL | ANDA 208443 | AB | Jan 16, 2024 |
Marketing exclusivity (2)
- ODE-367Orphan-drug exclusivity (7 years)
Jan 24, 2027
in 7 mo
- 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 |
| 8859510 | Jul 31, 2027 | in 1 yr 2 mo | U-2741 |
| 7378508 | Jul 31, 2027 | in 1 yr 2 mo | SubstanceProduct |
| 7863249 | Jul 31, 2027 | in 1 yr 2 mo | Product |
| 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 |
Fidaxomicin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
