FDA Orange Book · active-ingredient family
Fidaxomicin
Fidaxomicin: 2 brands, 4 generics; first approved May 27, 2011; generic available.
Generic available2 exclusivity periods
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
4
Listed patents
10
Next patent expiry
Mar 04, 2027
in 5 mo
Brand (NDA) products
Originator applications
Generic (ANDA) products (4)
Abbreviated applications
- FIDAXOMICINSANDOZANDA 2204652026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - FIDAXOMICINAPOTEXANDA 2195592026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - FIDAXOMICINTORRENTANDA 2203742026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB - FIDAXOMICINACTAVIS LABS FLANDA 2084432024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- ODE-367Orphan-drug exclusivity (7 years)
in 3 mo
- ODE-367Orphan-drug exclusivity (7 years)
in 3 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7906489 | in 5 mo | U-2741 | |
| 8859510 | in 10 mo | U-2741 | |
| 7378508 | in 10 mo | SubstanceProduct | |
| 7863249 | in 10 mo | Product | |
| 7906489*PED | in 11 mo | ||
| 7378508*PED | in 1 yr 4 mo | ||
| 7863249*PED | in 1 yr 4 mo | ||
| 8859510*PED | in 1 yr 4 mo | ||
| 9808530 | in 7 yr 9 mo | Product | |
| 9808530*PED | in 8 yr 3 mo |
Approval history
FDA approval span
First approval
15 yr 7 mo ago
Most recent approval
2 mo ago
Approvals span 2011–2026 across 6 FDA applications.
Brand (NDA) 233%
Generic (ANDA) 467%
Fidaxomicin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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