.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Ciprofloxacin - Generic Drug Details

« Back to Dashboard
Ciprofloxacin is the generic ingredient in sixteen branded drugs marketed by Bedford, Hikma Farmaceutica, Claris, Teva Pharms, Hospira, Bayer Hlthcare, Acs Dobfar Info Sa, Bayer Pharms, Lupin Ltd, Teva Pharms Usa, Fresenius Kabi Usa, Otonomy Inc, Baxter Hlthcare, Bedford Labs, Taro, Mylan, Wraser Pharms, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Depomed Inc, Sun Pharm Inds Ltd, Teligent Pharma Inc, Akorn Inc, Hikma, Aurobindo Pharma, Fdc Ltd, Alcon Pharms Ltd, Watson Labs Inc, Rising Pharms Inc, Ivax Sub Teva Pharms, Dr Reddys Labs Ltd, Sandoz, Watson Labs, Apotex, Pharmaforce, Laboratorios Salvat, Actavis Labs Fl Inc, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty-one NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and six patent family members in seventeen countries.

There are thirty drug master file entries for ciprofloxacin. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: ciprofloxacin

Tradenames:16
Patents:17
Applicants:45
NDAs:61
Drug Master File Entries: see list30
Suppliers / Packaging: see list10
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ciprofloxacin

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Tentative approvals for CIPROFLOXACIN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL100MG
<disabled><disabled>Tablet; Oral100MG

Clinical Trials for: ciprofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-001Sep 26, 1997RXNo<disabled><disabled>
Aurobindo Pharma
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL077859-002Apr 26, 2007RXNo<disabled><disabled>
Mylan
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075817-002Jun 9, 2004RXNo<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: ciprofloxacin

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019857-001Dec 26, 19904,705,789*PED<disabled>
Bayer Pharms
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019858-001Dec 26, 19904,705,789*PED<disabled>
Bayer Hlthcare
CIPRO
ciprofloxacin
INJECTABLE;INJECTION019847-001Dec 26, 19904,705,789*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: ciprofloxacin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,575,122Controlled release auris sensory cell modulator compositions and methods for the treatment of otic disorders<disabled in preview>
8,349,353Controlled release cytotoxic agent compositions and methods for the treatment of otic disorders<disabled in preview>
8,680,082Controlled release corticosteroid compositions and methods for the treatment of otic disorders<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: ciprofloxacin

Country Document Number Estimated Expiration
China102014957<disabled in preview>
South Korea20110033295<disabled in preview>
European Patent Office2303227<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: CIPROFLOXACIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0012France<disabled>PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

`abc