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Generated: June 19, 2018

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CIPRO Drug Profile

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

Cipro is a drug marketed by Bayer Hlthcare, Novartis Pharms Corp, Bayer Pharms, Lupin Ltd, Baxter Hlthcare Corp, Bedford Labs, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Mylan Pharms Inc, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms Inc, Teligent, Watson Labs Inc, Ani Pharms Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms. and is included in fifty-six NDAs. There are eight patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-one drug master file entries for this compound. Four suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
Drug patent expirations by year for CIPRO
Pharmacology for CIPRO
Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial
Synonyms for CIPRO
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-carboxylicacidhydrochloride
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
BB_SC-1870
BBC/258
BG0142
BIM-0048462.P001
C17H18FN3O3.HCl
Cambridge id 5807784
CAS-93107-08-5
Cetraxal
CHEBI:310388
CHEMBL1202
Ciprofloxacin HCl
CIPROFLOXACIN HCL/LACTATE
Ciprofloxacin hydrochloride
ciprofloxacin hydrochloride (anh.)
ciprofloxacin hydrochloride (anhydrous)
Ciprofloxacin Hydrochloride Anhydrous
Ciprofloxacin monohydrochloride
ciprofloxacine hydrochloride
Ciprofloxacinhydrochloride
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
HE064945
HMS1568G08
HY-B0356A
KB-218801
KS-000046JK
KS-5012
LS-141564
MFCD00079044
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

US Patents and Regulatory Information for CIPRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Carlsbad CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076126-004 Jun 9, 2004 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075747-002 Jun 9, 2004 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077809-001 Nov 30, 2010 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa CIPROFLOXACIN ciprofloxacin INJECTABLE;INJECTION 076484-001 Aug 28, 2006 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for CIPRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-003 Oct 22, 1987 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin INJECTABLE;INJECTION 019847-001 Dec 26, 1990 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for CIPRO
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Otic Suspension 0.3%/0.1% ➤ Subscribe 2012-07-31
➤ Subscribe Oral Suspension 250 mg/5 mL and 500 mg/ 5 mL ➤ Subscribe 2009-10-16

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Citi
Cipla
Harvard Business School
Mallinckrodt
Chinese Patent Office
Moodys
US Department of Justice
Express Scripts

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