Ciprofloxacin hydrochloride - Generic Drug Details

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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 seven branded drugs marketed by Sandoz, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Key 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, Yiling, and Laboratorios Salvat, and is included in thirty-four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for ciprofloxacin hydrochloride. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ciprofloxacin hydrochloride

US Patents:	1
Tradenames:	7
Applicants:	31
NDAs:	34
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	56
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	301
Patent Applications:	4,567
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
Institute of Cancer Research, United Kingdom	Phase 1/Phase 2
Prostate Cancer Foundation	Phase 1/Phase 2
Shanghai Pulmonary Hospital, Shanghai, China	Phase 4

See all ciprofloxacin hydrochloride clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 750MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 500MG BASE	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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
Watson Labs Inc	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	076673-001	Jan 21, 2005	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Natco	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075685-002	Jun 9, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076089-004	Jun 9, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075817-004	Jun 9, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
The J Molner	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	076754-001	Jun 9, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nostrum Labs	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076138-003	Jun 9, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Unique	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076639-003	Sep 10, 2004	AB	RX	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

Expired US Patents for ciprofloxacin hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-004	Oct 22, 1987	⤷ Sign Up	⤷ Sign Up
Sandoz	CILOXAN	ciprofloxacin hydrochloride	OINTMENT;OPHTHALMIC	020369-001	Mar 30, 1998	⤷ Sign Up	⤷ Sign Up
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	⤷ Sign Up	⤷ Sign Up
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-002	Oct 22, 1987	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-002	Oct 22, 1987	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-003	Oct 22, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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