FDA Orange Book · active-ingredient family
Ciprofloxacin
Ciprofloxacin: 5 brands, 16 generics; first approved Dec 26, 1990; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
16
Listed patents
8
Next patent expiry
Apr 21, 2029
in 2 yr 9 mo
Brand (NDA) products
Originator applications
- OTIPRIORLDALK ABELLONDA 2079862015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6% (60MG/ML) INJECTABLE, SUSPENSION OTIC Discontinued — - CIPRORLDBAYER HLTHCARENDA 02078019972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML FOR SUSPENSION ORAL Rx AB 500MG/5ML FOR SUSPENSION ORAL Rx AB - CIPRORLDBAYER HLTHCARENDA 01984719903 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG/40ML (10MG/ML) INJECTABLE INJECTION Discontinued — 200MG/20ML (10MG/ML) INJECTABLE INJECTION Discontinued — 1200MG/120ML (10MG/ML) INJECTABLE INJECTION Discontinued — - BAYER HLTHCARENDA 01985719902 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Discontinued — 400MG/200ML INJECTABLE INJECTION Discontinued — - BAYER PHARMSNDA 0198581990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- CIPROFLOXACINCHARTWELLANDA 20056320142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML FOR SUSPENSION ORAL Rx AB 500MG/5ML FOR SUSPENSION ORAL Rx AB - CIPROFLOXACINRSHIKMA FARMACEUTICAANDA 07671720092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/20ML (10MG/ML) INJECTABLE INJECTION Rx — 400MG/40ML (10MG/ML) INJECTABLE INJECTION Rx — - HIKMA FARMACEUTICAANDA 0784312009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG/200ML INJECTABLE INJECTION Rx AP - CIPROFLOXACINBAXTER HLTHCARE CORPANDA 07806220082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/20ML (10MG/ML) INJECTABLE INJECTION Discontinued — 400MG/40ML (10MG/ML) INJECTABLE INJECTION Discontinued — - HIKMA FARMACEUTICAANDA 0767572008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCAREANDA 07788820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Discontinued — 400MG/200ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCARE CORPANDA 07802420082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Discontinued — 400MG/200ML INJECTABLE INJECTION Discontinued — - BEDFORDANDA 07811420082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Discontinued — 400MG/200ML INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 07775320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Rx AP 400MG/200ML INJECTABLE INJECTION Rx AP - INFORLIFEANDA 07825220082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Rx AP 400MG/200ML INJECTABLE INJECTION Rx AP - TEVA PHARMSANDA 07713820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/100ML INJECTABLE INJECTION Discontinued — 400MG/200ML INJECTABLE INJECTION Discontinued — - CIPROFLOXACINBEDFORD LABSANDA 07699220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/20ML (10MG/ML) INJECTABLE INJECTION Discontinued — 400MG/40ML (10MG/ML) INJECTABLE INJECTION Discontinued — - CIPROFLOXACINBEDFORD LABSANDA 0769932006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1200MG/120ML (10MG/ML) INJECTABLE INJECTION Discontinued — - CIPROFLOXACINDR REDDYSANDA 07778220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/20ML (10MG/ML) INJECTABLE INJECTION Discontinued — 400MG/40ML (10MG/ML) INJECTABLE INJECTION Discontinued — - CIPROFLOXACINFRESENIUS KABI USAANDA 07648420062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/20ML (10MG/ML) INJECTABLE INJECTION Discontinued — 400MG/40ML (10MG/ML) INJECTABLE INJECTION Discontinued — - CIPROFLOXACINHOSPIRAANDA 07724520062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/20ML (10MG/ML) INJECTABLE INJECTION Discontinued — 400MG/40ML (10MG/ML) INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9603796 | in 2 yr 9 mo | SubstanceProductU-2252 | |
| 9205048 | in 2 yr 9 mo | U-1793 | |
| 11369566 | in 2 yr 9 mo | Product | |
| 9233068 | in 3 yr 4 mo | Product | |
| 8318817 | in 3 yr 9 mo | U-1792 | |
| 9220796 | in 9 yr | Product | |
| 11040004 | in 11 yr 5 mo | U-2252 | |
| 11246863 | in 12 yr 5 mo | Product |
Approval history
FDA approval span
First approval
36 yr 2 mo ago
Most recent approval
10 yr 10 mo ago
Approvals span 1990–2015 across 21 FDA applications.
Brand (NDA) 524%
Generic (ANDA) 1676%
Ciprofloxacin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
