Drug facts

Molecule

Ciprofloxacin (Cipro)

Generics already compete: 15 makers on the market. 33 A-rated products from 15 makers substitute at the counter.

Cipro was first approved by the FDA on 10/22/1987 under NDA 019537; the application holder is Bayer Healthcare Pharmaceuticals Inc.

The latest NADAC for CIPROFLOXACIN HCL 500 MG TAB is $0.12 per unit (as of 10/28/2026).

Holder Bayer Healthcare Pharmaceuticals IncApplication NDA 019537Approved 10/22/1987

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

Latest patent
No Cipro patent listed in the Orange Book
Orange Book

02Competition

Generics
15 generic makers
Orange Book
First generic approved
06/09/2004
Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Ciprofloxacin profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$0.12 per unitCIPROFLOXACIN HCL 500 MG TAB, mid-priced of 3 strengths, as of 10/28/2026
CMS NADAC
Latest recall
03/11/2025Class II, Ciprofloxacin, Fdc Limited
FDA enforcement

04Product

Application holder
Bayer Healthcare Pharmaceuticals Inc
Orange Book
Application
NDA 019537
Orange Book
First approved
10/22/1987
Orange Book
Dosage forms
ointment; solution/drops; tablet
Routes
ophthalmic, oral, otic
Other brand names
CetraxalCiloxan

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.