Cleocin T generics — when can they launch?
Cleocin T (CLINDAMYCIN PHOSPHATE) · Pfizer · 3 active US patents · 0 expired
Where Cleocin T sits in the generic timeline
Imminent generic cliff: earliest active US patent for Cleocin T expires in 2026 (~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.
- Method of Use — 2 patents
- Formulation — 1 patent
FDA U-codes carved out by Cleocin T 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-137 | (no description) |
U-3293 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Cleocin T drug page →
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This patent protects a pharmaceutical formulation for treating vaginal conditions in humans with a modified release dosage form that provides extended release of an anti-infective agent.USPTO title: Pharmaceutical delivery system
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This patent protects a pharmaceutical formulation and method for treating bacterial vaginosis using a specific combination of ingredients.USPTO title: Topical formulations and treatments
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This patent protects a pharmaceutical formulation for treating bacterial vaginosis that includes poloxamer F127, xanthan gum, water, and a therapeutically effective amount of a pharmaceutical active ingredient.USPTO title: Topical formulations and treatments
Sources
- FDA Orange Book — patents listed against Cleocin T (NDA filed 1972)
- Cleocin T drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2026 — 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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