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Last Updated: December 14, 2019

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Ciprofloxacin hydrochloride - Generic Drug Details

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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. Sixty 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
Janssen, LPPhase 3
Universitaire Ziekenhuizen LeuvenPhase 3
NeuroSense Therapeutics Ltd.Phase 2

See all ciprofloxacin hydrochloride clinical trials

Recent Litigation for ciprofloxacin hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
In re: Depomed, Inc.2015-12-30
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15
Purdue Pharma L.P. v. Depomed, Inc.2015-09-15

See all ciprofloxacin hydrochloride litigation

PTAB Litigation
PetitionerDate
Endo Pharmaceutical Inc.2014-04-17
Purdue Pharma L.P.2014-01-24

See all ciprofloxacin hydrochloride litigation

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
Synonyms for ciprofloxacin hydrochloride
0MP32MFP6C
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid HCl
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid monohydrochloride
1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)-1,4-dihydro-3-quinolinecarboxylic acid hydrochloride
1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride(1:x)
1-Cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-1,4-dihydro-quinoline-3-carboxylic acid; hydrochloride
1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-quinoline-3-carboxylic acid hydrochloride
1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic acid hydrochloride
1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic acid;hydrochloride
1-cyclopropyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid, ch loride
3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, hydrochloride
3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, monohydrochloride
3-Quinolinecarboxylic acid, 1,4-dihydro-1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)-, hydrochloride
4-(3-Carboxy-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-quinolin-7-yl)-piperazin-1-ium; chloride
86483-48-9
93107-08-5
9311AF
AC-23972
AC1L1Y6P
AC1Q3E6U
AK126819
AK176012
AKOS005111008
AN-35553
API0002028
ARONIS24122
AX8035163
BAY-o 9867
BAY-O-9867
Bay-o-9867 monohydrate
BBC/258
BCP13634
BCP14336
BG0142
BIM-0048462.P001
C17H18FN3O3.HCl
Cambridge id 5807784
CAS-93107-08-5
Cetraxal
CHEBI:310388
CHEMBL1202
Ciloxan
Cipro
Ciprofloxacin HCl
CIPROFLOXACIN HCL/LACTATE
ciprofloxacin hydrochloride (anh.)
ciprofloxacin hydrochloride (anhydrous)
Ciprofloxacin Hydrochloride Anhydrous
Ciprofloxacin monohydrochloride
ciprofloxacine hydrochloride
CS-8134
DIOIOSKKIYDRIQ-UHFFFAOYSA-N
DSSTox_CID_27768
DSSTox_GSID_47788
DSSTox_RID_82545
DTXSID1047788
Epitope ID:174846
F0001-2378
FT-0623850
FT-0623851
GP9406
HMS1568G08
HY-B0356A
KB-218801
KS-000046JK
KS-5012
LS-141564
MolPort-002-338-774
NCGC00016959-01
NCGC00016959-06
NSC-620634
NSC620634
Prestwick_67
Q-200860
SBB080619
SC-12658
SCHEMBL42310
Tox21_110712
Tox21_110712_1
UNII-0MP32MFP6C
Z-0831
ZX-AS004472
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
Depomed Inc PROQUIN XR ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744-001 May 19, 2005 DISCN No No   Start Trial   Start Trial Y   Start Trial
Teva CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076136-001 Jun 9, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075939-001 Mar 3, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075939-002 Jun 9, 2004 DISCN 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
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-001 Apr 8, 1996   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987   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 019537-002 Oct 22, 1987   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 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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Merck
McKesson
Mallinckrodt
Express Scripts

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