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CIPROFLOXACIN HYDROCHLORIDE Drug Profile

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When do Ciprofloxacin Hydrochloride patents expire, and what generic alternatives are available?

Ciprofloxacin Hydrochloride is a drug marketed by Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs 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, and Yiling Pharm Ltd. and is included in twenty-seven NDAs.

The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Ciprofloxacin Hydrochloride

A generic version of CIPROFLOXACIN HYDROCHLORIDE was approved as ciprofloxacin hydrochloride by TELIGENT on January 27^th, 2020.

Summary for CIPROFLOXACIN HYDROCHLORIDE

US Patents:	0
Applicants:	26
NDAs:	27
Suppliers / Packagers:	47
Bulk Api Vendors:	77
Clinical Trials:	224
Patent Applications:	1,671
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CIPROFLOXACIN HYDROCHLORIDE
DailyMed Link:	CIPROFLOXACIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CIPROFLOXACIN HYDROCHLORIDE

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

Sponsor	Phase
Janssen, LP	Phase 3
Universitaire Ziekenhuizen Leuven	Phase 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 Name	Date
In re: Depomed, Inc.	2015-12-30
Purdue Pharma L.P. v. Depomed, Inc.	2015-09-15
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2015-09-15

See all CIPROFLOXACIN HYDROCHLORIDE litigation

PTAB Litigation

Petitioner	Date
Endo Pharmaceutical Inc.	2014-04-17
Purdue Pharma L.P.	2014-01-24

See all CIPROFLOXACIN HYDROCHLORIDE litigation

Pharmacology for CIPROFLOXACIN HYDROCHLORIDE

Drug Class

Quinolone Antimicrobial

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
Mylan	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075685-003	Jun 9, 2004		DISCN	No	No
Hikma	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076558-002	Jun 9, 2004	AB	RX	No	No
Pliva	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076426-002	Jun 15, 2005		DISCN	No	No
Teva	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076136-002	Jun 9, 2004		DISCN	No	No
Nostrum Labs	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076138-001	Jun 9, 2004		DISCN	No	No
Pliva	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076426-003	Jun 15, 2005		DISCN	No	No
Taro	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076912-001	Feb 18, 2005	AB	RX	No	No