DrugPatentWatch Database Preview
Ciprofloxacin - Generic Drug Details
» See Plans and Pricing
What are the generic sources for ciprofloxacin and what is the scope of patent protection?
Ciprofloxacin
is the generic ingredient in seventeen branded drugs marketed by Bayer Hlthcare, Chartwell, Otonomy Inc, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Novartis, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, 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, Yiling, Laboratorios Salvat, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty-three NDAs. There are fifteen 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 forty-six 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: | 146 |
US Patents: | 15 |
Tradenames: | 17 |
Applicants: | 45 |
NDAs: | 63 |
Drug Master File Entries: | 34 |
Suppliers / Packagers: | 5 |
Bulk Api Vendors: | 105 |
Clinical Trials: | 240 |
Patent Applications: | 6,983 |
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 |
Recent Clinical Trials for ciprofloxacin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute for Health Research, United Kingdom | N/A |
University College, London | N/A |
Lee's Pharmaceutical Limited | Phase 3 |
Generic filers with tentative approvals for CIPROFLOXACIN
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
Drug Class | Quinolone Antimicrobial |
Medical Subject Heading (MeSH) Categories for ciprofloxacin
Paragraph IV (Patent) Challenges for CIPROFLOXACIN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
CIPRO | FOR SUSPENSION;ORAL | ciprofloxacin | 020780 | 2009-10-16 |
US Patents and Regulatory Information for ciprofloxacin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma Farmaceutica | CIPROFLOXACIN | ciprofloxacin | INJECTABLE;INJECTION | 076717-001 | Dec 22, 2009 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Baxter Hlthcare | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 077888-001 | Mar 18, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Ani Pharms Inc | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075939-003 | Jun 9, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Inforlife | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 078252-001 | Mar 18, 2008 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Barr | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 074124-001 | Jun 9, 2004 | DISCN | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Pharms | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 019858-001 | Dec 26, 1990 | Start Trial | Start Trial |
Bayer Hlthcare | CIPRO | ciprofloxacin | INJECTABLE;INJECTION | 019847-001 | Dec 26, 1990 | Start Trial | Start Trial |
Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-001 | Sep 26, 1997 | Start Trial | Start Trial |
Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-002 | Sep 26, 1997 | Start Trial | Start Trial |
Bayer Pharms | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 019858-001 | Dec 26, 1990 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ciprofloxacin
Country | Patent Number | Estimated Expiration |
---|---|---|
Chile | 2009000956 | Start Trial |
United Kingdom | 0823378 | Start Trial |
China | 102112111 | Start Trial |
China | 102105133 | Start Trial |
Brazil | PI0910850 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ciprofloxacin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1429780 | 132013902137451 | Italy | Start Trial | PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106 |
1429780 | 13C0012 | France | Start Trial | 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 | SPC/GB12/058 | United Kingdom | Start Trial | 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 | Start Trial | PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:






Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.