Who owns the fidaxomicin (Dificid) patents, and what are the key patent types?
Fidaxomicin is the active ingredient in Dificid (Merck’s brand). The key “patent questions” people ask for drugs like fidaxomicin usually split into (1) compound or formulation patents, (2) method-of-use patents, and (3) exclusivity protections that can extend protection even after a patent expires.
When do fidaxomicin patents expire?
The exact expiration dates depend on which specific patent family, country, and patent number you mean. Patent terms also differ for primary patents versus later-life patents (for example, specific formulations, polymorphs, or dosing regimens), and they can be adjusted by patent term extensions where permitted.
Can exclusivity extend beyond patent expiry for fidaxomicin?
Yes. For brand drugs, regulatory exclusivity can extend market protection even after certain patents end. Whether this applies to fidaxomicin depends on the specific U.S. regulatory pathway and the timing of approvals, and it will vary by jurisdiction (U.S. vs. EU vs. elsewhere).
Are there challenges from generics or biosimilars for fidaxomicin?
For small-molecule antibiotics like fidaxomicin, the main competitive threat is typically generic entry (or “authorized” competition) after patents and exclusivity end. The details depend on what patents the brand listed and which claims a generic targets.
Which countries have the most relevant fidaxomicin patent filings?
Users usually care about the U.S. (FDA/NDA exclusivity and Orange Book listings), the European Union (EMA/Member State enforcement), and sometimes other large markets. The patent landscape can differ widely by country because filings and prosecution outcomes vary.
How to look up the exact fidaxomicin patent(s) and expiration date you need
If you want the precise expiration timeline, the most direct route is to search:
- U.S. FDA Orange Book for Dificid and identify each listed patent, then check its listed expiration date.
- The relevant patent offices (USPTO/EP/WO) for the underlying patent numbers in that family.
If you tell me the jurisdiction (U.S. or EU, etc.) and whether you mean Dificid specifically, I can help you pinpoint what to look for and how to interpret the listed expiration dates.
What to share so I can give a precise answer
To answer “When does the fidaxomicin patent expire?” with exact dates, share one of the following:
- the country/jurisdiction (e.g., “U.S.”),
- the brand name (e.g., “Dificid”),
- or the patent numbers (or an Orange Book listing ID) you’re looking at.
Sources
No sources were provided in your prompt, so I can’t cite specific patent numbers or expiration dates accurately.