Dificid generics — when can they launch?
Dificid (FIDAXOMICIN) · Cubist Pharms Llc · 18 active US patents · 0 expired
Where Dificid sits in the generic timeline
Imminent generic cliff: earliest active US patent for Dificid expires in 2027 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Other — 9 patents
- Method of Use — 4 patents
- Composition of Matter — 3 patents
- Formulation — 2 patents
FDA U-codes carved out by Dificid patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-319 | (no description) |
U-2741 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the Dificid drug page →
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This patent protects the use of OPT-80, a potent drug for treating C. difficile infections, which is also known as Dificid.USPTO title: 18-membered macrocycles and analogs thereof
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This patent protects the use of OPT-80, a potent drug for treating C. difficile infections, which is also known as Dificid.USPTO title: 18-membered macrocycles and analogs thereof
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This patent protects novel forms of compounds with broad spectrum antibiotic activity, including crystalline and amorphous forms, and methods for their manufacture and use.USPTO title: Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
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This patent protects novel forms of compounds with broad-spectrum antibiotic activity, including crystalline and amorphous forms, and methods for manufacturing and using them.USPTO title: Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
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This patent protects novel forms of compounds with broad spectrum antibiotic activity, including crystalline and amorphous forms, and methods for their manufacture and use.USPTO title: Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
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This patent protects novel crystalline and amorphous forms of the antibiotic compound tiacumicin B.USPTO title: Polymorphic crystalline forms of tiacumicin B
Sources
- FDA Orange Book — patents listed against Dificid (NDA filed 2011)
- Dificid drug profile — full patent estate, indications, clinical trials, pricing
- Cubist Pharms Llc patent portfolio
- Patent cliff 2027 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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