You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Dow
Moodys
AstraZeneca
Express Scripts
McKesson
Baxter

Last Updated: August 10, 2020

DrugPatentWatch Database Preview

CIPROFLOXACIN HYDROCHLORIDE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic sources for ciprofloxacin hydrochloride and what is the scope of patent protection?

Ciprofloxacin hydrochloride is the generic ingredient in seven branded drugs marketed by Novartis, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Bayer Hlthcare, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, Yiling Pharm Ltd, and Laboratorios Salvat, and is included in thirty-four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin hydrochloride has nineteen patent family members in fourteen countries.

There are thirty-four drug master file entries for ciprofloxacin hydrochloride. Fifty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for CIPROFLOXACIN HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Women and Children's Health Research Institute, CanadaPhase 4
Department for International Development, United KingdomPhase 4
Wellcome TrustPhase 4

See all CIPROFLOXACIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 750MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 500MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 250MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CIPROFLOXACIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CIPROFLOXACIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CIPRO TABLET;ORAL ciprofloxacin hydrochloride 019537

US Patents and Regulatory Information for CIPROFLOXACIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amring Pharms CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 078598-001 Jan 16, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075747-003 Jun 9, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075817-004 Jun 9, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Carlsbad CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076126-003 Jun 9, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CIPROFLOXACIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc PROQUIN XR ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744-001 May 19, 2005   Start Trial   Start Trial
Novartis CILOXAN ciprofloxacin hydrochloride OINTMENT;OPHTHALMIC 020369-001 Mar 30, 1998   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-001 Apr 8, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CIPROFLOXACIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 SPC/GB12/058 United Kingdom   Start Trial PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1429780 122012000070 Germany   Start Trial PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
1429780 13C0012 France   Start Trial 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
1429780 132013902137451 Italy   Start Trial PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Medtronic
Dow
AstraZeneca
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.