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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 ciprofloxacin 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, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Novartis Pharms Corp, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms Inc, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Ani Pharms Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Laboratorios Salvat, Actavis Labs Fl Inc, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty-two 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 twenty-eight patent family members in nineteen countries.

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

Summary for ciprofloxacin

International Patents:	128
US Patents:	15
Tradenames:	16
Applicants:	46
NDAs:	62
Drug Master File Entries:	31
Suppliers / Packagers:	10
Bulk Api Vendors:	80
Clinical Trials:	189
Patent Applications:	6,919
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ciprofloxacin
DailyMed Link:	ciprofloxacin at DailyMed

Pharmacology for ciprofloxacin

Ingredient-type	Quinolones
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-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

AK163192

AKOS000269653

ALBB-015909

Alcon Cilox

AN-8829

ARONIS020379

AuriPro

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

BDBM21690

Bernoflox

Bi-Cipro

BIDD:GT0205

Bio-0540

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

ciprofloxacillin

Ciprofloxacin (Cipro)

Ciprofloxacin (JP17/USP/INN)

Ciprofloxacin [USAN:INN:BAN]

Ciprofloxacin [USAN:USP:INN:BAN]

Ciprofloxacin dihydrochloride

CIPROFLOXACIN EXTENDED RELEASE

Ciprofloxacin Hydrchloride

Ciprofloxacin In Dextrose 5%

Ciprofloxacin In Dextrose 5% In Plastic Container

Ciprofloxacin intratympanic - Otonomy

Ciprofloxacin monohydrochloride

Ciprofloxacin, >=98.0% (HPLC)

Ciprofloxacin, Antibiotic for Culture Media Use Only

Ciprofloxacin, European Pharmacopoeia (EP) Reference Standard

Ciprofloxacin, pharmaceutical secondary standard; traceable to USP and PhEur

Ciprofloxacin, United States Pharmacopeia (USP) Reference Standard

Ciprofloxacin, VETRANAL(TM), analytical standard

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

D03IHU

D0JW1A

DB00537

DivK1c_000095

DR001566

DTXSID8022824

Eni

Fimoflox

Flociprin

FT-0601635

HE397506

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

OTO-201

Pharmakon1600-01503614

Prestwick0_000113

Prestwick1_000113

Prestwick2_000113

Prestwick3_000113

Probiox

Proflaxin

Proksi 250

Proksi 500

Quinolid

Quintor

Rancif

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-05000001863-3

ST024751

ST24046329

STK021082

Superocin

TX-017484

Unex

UNII-5E8K9I0O4U

Velmonit

Velomonit

Z56933707

ZINC20220

Zumaflox

Tentative approvals for CIPROFLOXACIN

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

US Patents and Regulatory Information for ciprofloxacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	CIPROFLOXACIN	ciprofloxacin	INJECTABLE;INJECTION	077245-001	Aug 28, 2006	AP	RX	No	No
Baxter Hlthcare Corp	CIPROFLOXACIN	ciprofloxacin	INJECTABLE;INJECTION	078062-001	Apr 29, 2008	AP	RX	No	Yes
Hikma Farmaceutica	CIPROFLOXACIN	ciprofloxacin	INJECTABLE;INJECTION	076717-002	Dec 22, 2009	AP	RX	No	No
Lupin Ltd	CIPROFLOXACIN	ciprofloxacin	FOR SUSPENSION;ORAL	200563-002	Mar 5, 2014	AB	RX	No	No

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Expired US Patents for ciprofloxacin

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

Non-Orange Book US Patents for 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
8,648,119	Controlled release immunomodulator compositions and methods for the treatment of otic disorders
8,399,018	Controlled release ion channel modulator compositions and methods for the treatment of otic disorders
8,030,297	Controlled release corticosteroid compositions and methods for the treatment of OTIC disorders
9,333,171	Controlled-release CNS modulating compositions and methods for the treatment of otic disorders

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International Patents for ciprofloxacin

Country	Document Number	Estimated Expiration
Canada	2732686
Australia	2009239429
Canada	2730847
World Intellectual Property Organization (WIPO)	2010011609

Supplementary Protection Certificates for ciprofloxacin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0012	France		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
C/GB12/058	United Kingdom		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