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Generated: July 26, 2017
What are the generic sources for ciprofloxacin and what is the scope of ciprofloxacin patent protection?
Ciprofloxacin is the generic ingredient in sixteen branded drugs marketed by Bedford, Hikma Farmaceutica, Claris, Teva Pharms, Hospira, Bayer Hlthcare, Acs Dobfar Info Sa, Bayer Pharms, Lupin Ltd, Teva Pharms Usa, Fresenius Kabi Usa, Otonomy Inc, Baxter Hlthcare, Bedford Labs, Taro Pharm, Mylan, Wraser Pharms, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Depomed Inc, Sun Pharm Inds Ltd, Teligent, Akorn Inc, Hikma, Aurobindo Pharma, Fdc Ltd, Novartis Pharms Corp, Watson Labs Inc, Rising Pharms Inc, Ivax Sub Teva Pharms, Dr Reddys Labs Ltd, Sandoz, Watson Labs, Apotex, Amring Pharms, Laboratorios Salvat, Actavis Labs Fl Inc, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty-one NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 16 |
| Patents: | 18 |
| Applicants: | 45 |
| NDAs: | 61 |
| Drug Master File Entries: see list | 31 |
| Suppliers / Packagers: see list | 10 |
| Bulk Api Vendors: see list | 70 |
| Clinical Trials: see list | 180 |
| Patent Applications: see list | 6,417 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | ciprofloxacin at DailyMed |
| Ingredient-type | Quinolones |
| Drug Class | Quinolone Antimicrobial |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | EQ 750MG BASE | TABLET;ORAL |
| ► Subscribe | ► Subscribe | EQ 500MG BASE | TABLET;ORAL |
| ► Subscribe | ► Subscribe | EQ 250MG BASE | TABLET;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pliva | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076426-004 | Jun 15, 2005 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Watson Labs | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076794-003 | Jun 9, 2004 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Mylan | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075685-003 | Jun 9, 2004 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Ivax Sub Teva Pharms | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076089-004 | Jun 9, 2004 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Mylan | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075817-004 | Jun 9, 2004 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 019857-001 | Dec 26, 1990 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-001 | Sep 26, 1997 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Bayer Pharms | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 019858-001 | Dec 26, 1990 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Bayer Hlthcare | CIPRO | ciprofloxacin | INJECTABLE;INJECTION | 019847-001 | Dec 26, 1990 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-001 | Sep 26, 1997 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,575,122 | Controlled release auris sensory cell modulator compositions and methods for the treatment of otic disorders | ► Subscribe | |||||||||||||||||||||||||||
| 8,846,770 | Controlled release aural pressure modulator compositions and methods for the treatment of OTIC disorders | ► Subscribe | |||||||||||||||||||||||||||
| 8,784,870 | Controlled release compositions for modulating free-radical induced damage and methods of use thereof | ► Subscribe | |||||||||||||||||||||||||||
| 9,427,472 | Controlled release compositions for modulating free-radical induced damage and methods of use thereof | ► Subscribe | |||||||||||||||||||||||||||
| 8,030,297 | Controlled release corticosteroid compositions and methods for the treatment of OTIC disorders | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2009274229 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 201008598 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20160029870 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 2461962 | ► Subscribe | |||||||||||||||||||||||||||
| China | 102112112 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB12/058 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C0012 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ 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 verifification 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.
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