Last Updated: November 9, 2026

Ciprofloxacin hydrochloride - Generic Drug Details

Name: ciprofloxacin hydrochloride Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for ciprofloxacin hydrochloride and what is the scope of freedom to operate?

Ciprofloxacin hydrochloride is the generic ingredient in eight branded drugs marketed by Sandoz, Altaire Pharms Inc, Fdc Ltd, J Molner, Pharmobedient, Rising, Rubicon Research, The J Molner, Watson Labs Inc, Lab Salvat, Alembic Therap, Depomed Inc, Bayer Hlthcare, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, and Cosette Pharms Nc, and is included in thirty-six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fifty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ciprofloxacin hydrochloride

US Patents:	1
Tradenames:	8
Applicants:	32
NDAs:	36
Finished Product Suppliers / Packagers:	54
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	327
Patent Applications:	6,165
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ciprofloxacin hydrochloride
What excipients (inactive ingredients) are in ciprofloxacin hydrochloride?	ciprofloxacin hydrochloride excipients list
DailyMed Link:	ciprofloxacin hydrochloride at DailyMed

Recent Clinical Trials for ciprofloxacin hydrochloride

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

Sponsor	Phase
Faiz ur rahman	NA
Stanford University	EARLY_PHASE1
Uppsala Clinical Research Center, Sweden	PHASE4

See all ciprofloxacin hydrochloride clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE

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

Drug Class	Fluoroquinolone Antibacterial Quinolone Antimicrobial
Mechanism of Action	Cytochrome P450 1A2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ciprofloxacin hydrochloride

US Patents and Regulatory Information for ciprofloxacin hydrochloride

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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
Taro	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076912-003	Oct 6, 2004		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Taro	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076912-002	Oct 6, 2004		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ivax Sub Teva Pharms	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076089-003	Jun 9, 2004	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ivax Sub Teva Pharms	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076089-004	Jun 9, 2004	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Chartwell	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076896-001	Nov 4, 2004	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Unique	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076639-002	Sep 10, 2004	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Watson Labs	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076794-004	Jun 9, 2004	AB	RX	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 hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	5,972,389	⤷ Start Trial
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,635,280	⤷ Start Trial
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,488,962	⤷ Start Trial
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,340,475	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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