Cipro generics — when can they launch?
Cipro (Ciprofloxacin) · Alk Abello · 8 active US patents · 0 expired
Where Cipro sits in the generic timeline
Imminent generic cliff: earliest active US patent for Cipro expires in 2029 (~3 years 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.
- Formulation — 4 patents
- Method of Use — 4 patents
FDA U-codes carved out by Cipro 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-1793 | (no description) |
U-2252 | (no description) |
U-1792 | (no description) |
Sample patent estate
Showing 6 of 8 active US patents. View full estate on the Cipro drug page →
-
This patent protects controlled release compositions and methods for treating otic disorders with antimicrobial agents administered directly to the affected area.USPTO title: Controlled release antimicrobial compositions and methods for the treatment of otic disorders
-
This patent protects methods and compositions for treating otic diseases or conditions using antimicrobial agents applied directly to the affected area.USPTO title: Controlled release antimicrobial compositions and methods for the treatment of otic disorders
-
This patent protects methods and compositions for treating otic diseases or conditions using antimicrobial agents applied directly to the affected area.USPTO title: Controlled release antimicrobial compositions and methods for the treatment of otic disorders
-
This patent protects controlled release compositions and methods for treating otic diseases or conditions with antimicrobial agents administered directly to the affected ear area.USPTO title: Controlled release antimicrobial compositions and methods for the treatment of OTIC disorders
-
This patent protects methods and compositions for treating otic diseases or conditions using antimicrobial agents applied directly to the affected area.USPTO title: Controlled release antimicrobial compositions and methods for the treatment of otic disorders
-
This patent protects methods for making sterilized ciprofloxacin compositions, including otic formulations, through a specific heating and cooling process.USPTO title: Sterilization of ciprofloxacin composition
Sources
- FDA Orange Book — patents listed against Cipro (NDA filed 1987)
- Cipro drug profile — full patent estate, indications, clinical trials, pricing
- Alk Abello patent portfolio
- Patent cliff 2029 — 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.
Get generic entry alerts
Free Pharma CI alerts on Cipro — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →