CIPROFLOXACIN - Generic Drug Details

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

Ciprofloxacin is the generic ingredient in eighteen branded drugs marketed by Bayer Hlthcare, Chartwell, Alk Abello, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Sandoz, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rising, Rubicon, Saptalis Pharms, Watson Labs Inc, Key Therap, Depomed Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Laboratorios Salvat, Anchen Pharms, Ani Pharms, Fosun Pharma, Sentiss, and Sun Pharm, and is included in sixty-six NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin has one hundred and fifty patent family members in twenty countries.

There are thirty-four drug master file entries for ciprofloxacin. Five suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for CIPROFLOXACIN

International Patents:	150
US Patents:	10
Tradenames:	18
Applicants:	48
NDAs:	66
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	301
Patent Applications:	7,176
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for CIPROFLOXACIN
Drug Sales Revenues:	Drug sales revenues for CIPROFLOXACIN
What excipients (inactive ingredients) are in CIPROFLOXACIN?	CIPROFLOXACIN excipients list
DailyMed Link:	CIPROFLOXACIN at DailyMed

See drug prices for CIPROFLOXACIN

Drug Sales Revenue Trends for CIPROFLOXACIN

See drug sales revenues for CIPROFLOXACIN

Recent Clinical Trials for CIPROFLOXACIN

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 clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN

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

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

Medical Subject Heading (MeSH) Categories for CIPROFLOXACIN

Anti-Bacterial Agents
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CIPROFLOXACIN

Paragraph IV (Patent) Challenges for CIPROFLOXACIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CIPRO	Oral Suspension	ciprofloxacin	250 mg/5 mL and 500 mg/ 5 mL	020780	1	2009-10-16

US Patents and Regulatory Information for CIPROFLOXACIN

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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
Teva	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076136-003	Jun 9, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Key Therap	CETRAXAL	ciprofloxacin hydrochloride	SOLUTION/DROPS;OTIC	021918-001	May 1, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	CIPROFLOXACIN EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077809-002	Nov 30, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076136-001	Jun 9, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Carlsbad	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076126-003	Jun 9, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Ltd	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075593-002	Jun 9, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	077888-001	Mar 18, 2008		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

Expired US Patents for CIPROFLOXACIN

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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 Pharms	CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019858-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
Bayer Pharms	CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019858-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-001	Sep 26, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CIPROFLOXACIN

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Country	Patent Number	Title	Estimated Expiration
Japan	6207093		⤷ Sign Up
European Patent Office	2296632	COMPOSITIONS ET PROCÉDÉS MODULANT L APOPTOSE À LIBÉRATION CONTRÔLÉE POUR LE TRAITEMENT DE TROUBLES OTIQUES (CONTROLLED-RELEASE APOPTOSIS MODULATING COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTIC DISORDERS)	⤷ Sign Up
South Korea	20190026056	귀 질환 및 병태를 치료하기 위한 귀 조제물 (AURIS FORMULATIONS FOR TREATING OTIC DISEASES AND CONDITIONS)	⤷ Sign Up
Russian Federation	2010150863	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ЛЕЧЕНИЯ УШНЫХ ЗАБОЛЕВАНИЙ	⤷ Sign Up
Japan	6014069		⤷ Sign Up
United Kingdom	2461961	Sterile anti-apoptotic agent for treatment of ear diseases	⤷ Sign Up
Hong Kong	1215394	控制釋放型耳結構調節和先天性免疫系統調節組合物、裝置以及治療耳部病症的方法 (CONTROLLED-RELEASE OTIC STRUCTURE MODULATING AND INNATE IMMUNE SYSTEM MODULATING COMPOSITIONS, DEVICES, AND METHODS FOR THE TREATMENT OF OTIC DISORDERS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CIPROFLOXACIN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	SPC/GB12/058	United Kingdom	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1429780	122012000070	Germany	⤷ Sign Up	PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
1429780	13C0012	France	⤷ Sign Up	PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1429780	132013902137451	Italy	⤷ Sign Up	PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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