What FDA approval date applies to fidaxomicin?
Fidaxomicin (brand: Dificid) received FDA approval on May 27, 2011. [1]
When does fidaxomicin exclusivity expire (and what kind of exclusivity)?
For drugs like fidaxomicin, the key timing drivers are usually:
- New Chemical Entity (NCE) exclusivity (5 years) when applicable, and
- Patent term (separate from regulatory exclusivity).
The provided sources here only establish the FDA approval date and do not include the specific regulatory exclusivity end date. To determine the exact exclusivity expiration date for fidaxomicin, you’d need the drug’s exclusivity record details (e.g., NCE status and whether any additional exclusivity periods apply). [1]
Why you may see different “exclusivity” dates online
Different websites may report different dates because they mix:
- FDA exclusivity (regulatory non-approval periods),
- Hatch-Waxman patent listings (Orange Book patent expiry), or
- commercial timelines that assume generic launch conditions.
Those are related but not the same concept, so the “exclusivity expiration” date you see may reflect patents rather than FDA exclusivity.
Where to verify fidaxomicin’s exact exclusivity and patent expiry
The most direct way is to check:
- the drug’s FDA exclusivity information, and
- the Orange Book for listed patents tied to the approved NDA.
The approval date source below is a starting point, but the exact exclusivity expiration requires looking up the exclusivity terms in FDA records/Orange Book. [1]
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Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202593