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Last Updated: November 18, 2019

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Ciprofloxacin - Generic Drug Details

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

Ciprofloxacin is the generic ingredient in sixteen branded drugs marketed by Bayer Hlthcare, Lupin Ltd, Otonomy Inc, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Novartis, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, 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, Laboratorios Salvat, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty-three NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin has one hundred and forty patent family members in twenty countries.

There are thirty-four drug master file entries for ciprofloxacin. Seven suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for ciprofloxacin

International Patents:	140
US Patents:	15
Tradenames:	16
Applicants:	46
NDAs:	63
Drug Master File Entries:	34
Suppliers / Packagers:	7
Bulk Api Vendors:	97
Clinical Trials:	217
Patent Applications:	6,921
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ciprofloxacin
Drug Sales Revenues:	Drug sales revenues for ciprofloxacin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ciprofloxacin
DailyMed Link:	ciprofloxacin at DailyMed

See drug prices for ciprofloxacin

Drug Sales Revenue Trends for ciprofloxacin

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Recent Clinical Trials for ciprofloxacin

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Sponsor	Phase
Janssen, LP	Phase 3
Universitaire Ziekenhuizen Leuven	Phase 3
Germans Trias i Pujol Hospital	N/A

See all ciprofloxacin clinical trials

Recent Litigation for ciprofloxacin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Baker v. Bayer Aktiengescellschaft Corporation	2010-04-13
Bayer Schering Pharma AG v. Lupin Ltd.	2010-02-18
Bayer Schering Pharma AG v. Lupin Ltd.	2010-02-17

See all ciprofloxacin litigation

Generic filers with tentative approvals for CIPROFLOXACIN

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	EQ 250MG BASE	TABLET;ORAL
Start Trial	Start Trial	EQ 750MG BASE	TABLET;ORAL
Start Trial	Start Trial	EQ 500MG BASE	TABLET;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

Drug Class	Quinolone Antimicrobial

Medical Subject Heading (MeSH) Categories for ciprofloxacin

Anti-Bacterial Agents
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

Synonyms for ciprofloxacin

1-Cyclopropyl-6-fluoro-1,4-dihydro 4-oxo-7-[1-piperazinyl)-quinoline-3-carboxylic Acid
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7- (1-piperazinyl)-3-quinoline-carboxylic acid
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3- quinolinecarboxylic acid
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-quinoline -3-carboxylic acid
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-quinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)quinoline-3-carboxylic acid
1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperzinyl)-3-quinolinecarboxylic acid HCl H2O
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1piperazinyl)-3quinolinecarboxylic acid
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(piperazin-1-yl)-quinoline-3-carboxylic acid
1-Cyclopropyl-6-fluoro-1,4-dihydro-7-(1-piperazinyl)-4-oxo-3-quinoline carboxylic acid
1-Cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)-1,4-dihydro-3-quinolinecarboxylic acid
1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid
1-Cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-1,4-dihydro-quinoline-3-carboxylic acid
1-CYCLOPROPYL-6-FLUORO-4-OXO-7-PIPERAZIN-1-YL-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID
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-quinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid
1-Cyclopropyl-6-fluoro-7-(4-methyl-piperazin-1-yl)-4-oxo-1,4-dihydro-quinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-7-(piperazin-1-yl)-1,4-dihydro-4-oxoquinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-7-hexahydro-1-pyrazinyl-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid
3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-
3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, hydrochloride
3-Quinolinecarboxylic acid, 1,4-dihydro-1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)-
3-Quinolinecarboxylic acid,1,4-dihydro-1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)
3-Quinolinecarboxylicacid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-
5E8K9I0O4U
721C331
85721-33-1
A-8526
AB0011928
AB1009412
AC-7613
AC1L1EEW
AJ-08409
AKOS000269653
ALBB-015909
Alcon Cilox
AN-8829
ARONIS020379
AuriPro
Bacquinor
Baflox
BAS 06989041
Bay 09867
Bay o 9867
Bay o 9867 (Hydrochloride)
BAY q 3939
Bay-09867
BAY-o 9867
BAY-Q-3939
Baycip
BAYQ3939
BBL005612
BC203729
BCP28586
BDBM21690
Bernoflox
Bi-Cipro
BIDD:GT0205
BPBio1_000140
BRD-K04804440-311-02-3
BRN 3568352
BSPBio_000126
BSPBio_003344
C05349
C17H18FN3O3
CAS-93107-08-5
CBMicro_048498
CCG-39345
CCRIS 5241
Cetraxal
CHEBI:100241
CHEMBL8
Ciflox
Cifloxin
Cilab
Ciloxan
Ciloxan (Hydrochloride)
Ciplus
Ciprecu
Ciprine
Ciprinol
Cipro
Cipro (Hydrochloride)
Cipro (TN)
Cipro I.V.
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Cipro IV
Cipro XL
Cipro XR
Ciprobay
Ciprobay Uro
Ciprocinol
Ciprodar
Ciproflox
Ciprofloxacin (Cipro)
Ciprofloxacin (JP17/USP/INN)
Ciprofloxacin [USAN:INN:BAN]
Ciprofloxacin [USAN:USP:INN:BAN]
Ciprofloxacin dihydrochloride
CIPROFLOXACIN EXTENDED RELEASE
Ciprofloxacin Hydrchloride
Ciprofloxacin monohydrochloride
Ciprofloxacin, >=98.0% (HPLC)
Ciprofloxacin, 98%
Ciprofloxacin, Antibiotic for Culture Media Use Only
Ciprofloxacin, European Pharmacopoeia (EP) Reference Standard
Ciprofloxacin, Pharmaceutical Secondary Standard; Certified Reference Material
Ciprofloxacin, United States Pharmacopeia (USP) Reference Standard
Ciprofloxacin, VETRANAL(TM), analytical standard
Ciprofloxacin,(S)
Ciprofloxacina
Ciprofloxacine
Ciprofloxacine [INN-French]
Ciprofloxacino
Ciprofloxacino [INN-Spanish]
Ciprofloxacinum
Ciprofloxacinum [INN-Latin]
Ciprogis
Ciprolin
Ciprolon
Cipromycin
Ciproquinol
Ciprowin
Ciproxan
Ciproxin
Ciproxina
Ciproxine
Ciriax
Citopcin
Cixan
Corsacin
CPD000471901
CPF
CPFX
CS-2410
CTK3E8144
Cycin
Cyprobay
D00186
DB00537
DivK1c_000095
DTXSID8022824
Eni
Fimoflox
Flociprin
FT-0601635
HMS1922E18
HMS2090O07
HMS2093I03
HMS500E17
HSDB 6987
HY-B0356
IDI1_000095
Ipiflox
Italnik
J10137
KB-117181
KB-152640
KBio1_000095
KBio2_000642
KBio2_003210
KBio2_005778
KBio3_002846
KBioGR_001567
KBioSS_000642
KS-000002BQ
KS-00004C43
KS-5006
Linhaliq
Linhaliq [Liposomal Formulation]
Loxan
LS-141563
MCULE-8631780654
MFCD00185755
MLS001336035
MLS006011837
MolPort-000-819-654
MYSWGUAQZAJSOK-UHFFFAOYSA-N
NCGC00016959-01
NCGC00016959-02
NCGC00016959-03
NCGC00016959-04
NCGC00016959-05
NCGC00016959-07
NCGC00095058-01
NCGC00095058-02
NCGC00178128-01
NINDS_000095
NSC-758467
NSC620634
NSC758467
Oprea1_008239
Oprea1_313572
Otiprio
Pharmakon1600-01503614
Prestwick0_000113
Prestwick1_000113
Prestwick2_000113
Prestwick3_000113
Probiox
Proflaxin
Proksi 250
Proksi 500
Quinolid
Quintor
Rancif
RKL10073
Roxytal
s2027
SAM002264604
SBB012554
SBI-0048462.P003
SC-17889
SCHEMBL2900
Septicide
SMP1_000125
SMR000471901
Sophixin Ofteno
SPBio_001474
SPBio_002065
Spectrum_000162
SPECTRUM1503614
Spectrum2_001567
Spectrum3_001872
Spectrum4_000874
Spectrum5_001089
Spitacin
SR-05000001863
SR-05000001863-1
SR-05000001863-3
ST024751
ST24046329
STK021082
Superocin
TX-017484
Unex
UNII-5E8K9I0O4U
Velmonit
Velomonit
Z56933707
ZINC20220
Zumaflox

Paragraph IV (Patent) Challenges for CIPROFLOXACIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
CIPRO	FOR SUSPENSION;ORAL	ciprofloxacin	020780	2009-10-16

US Patents and Regulatory Information for ciprofloxacin

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pliva	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076426-001	Jun 15, 2005		DISCN	No	No	Start Trial	Start Trial				Start Trial
Laboratorios Salvat	OTOVEL	ciprofloxacin hydrochloride; fluocinolone acetonide	SOLUTION/DROPS;OTIC	208251-001	Apr 29, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Baxter Hlthcare Corp	CIPROFLOXACIN	ciprofloxacin	INJECTABLE;INJECTION	078062-002	Apr 29, 2008	AP	RX	No	Yes	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
Dr Reddys	CIPROFLOXACIN	ciprofloxacin	INJECTABLE;INJECTION	077782-001	Aug 28, 2006		DISCN	No	No	Start Trial	Start Trial				Start Trial
Fosun Pharma	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076593-003	Jun 9, 2004		DISCN	No	No	Start Trial	Start Trial				Start Trial
Teva	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076136-003	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Pharms	CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019858-001	Dec 26, 1990	Start Trial	Start Trial
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990	Start Trial	Start Trial
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990	Start Trial	Start Trial
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-001	Sep 26, 1997	Start Trial	Start Trial
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-002	Sep 26, 1997	Start Trial	Start Trial
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-002	Sep 26, 1997	Start Trial	Start Trial
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ciprofloxacin

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Country	Patent Number	Estimated Expiration
Japan	2019085423	Start Trial
South Korea	20160029870	Start Trial
Canada	2721927	Start Trial
Hong Kong	1215394	Start Trial
Canada	2730847	Start Trial
Israel	251768	Start Trial
South Korea	101390607	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ciprofloxacin

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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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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