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CIPROFLOXACIN HYDROCHLORIDE Drug Profile

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Which patents cover Ciprofloxacin Hydrochloride, 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-one 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 June 9^th, 2004.

Summary for CIPROFLOXACIN HYDROCHLORIDE

US Patents:	0
Applicants:	26
NDAs:	27
Suppliers / Packagers:	45
Bulk Api Vendors:	82
Clinical Trials:	228
Patent Applications:	1,708
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
Department for International Development, United Kingdom	Phase 4
Wellcome Trust	Phase 4
Medical Research Council	Phase 4

See all CIPROFLOXACIN HYDROCHLORIDE clinical trials

Pharmacology for CIPROFLOXACIN HYDROCHLORIDE

Drug Class

Quinolone Antimicrobial

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