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CIPROFLOXACIN HYDROCHLORIDE Drug Profile
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Which patents cover Ciprofloxacin Hydrochloride, and what generic alternatives are available?
Ciprofloxacin Hydrochloride is a drug marketed by Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell, 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, and Yiling. and is included in twenty-seven NDAs.
The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ciprofloxacin Hydrochloride
A generic version of CIPROFLOXACIN HYDROCHLORIDE was approved as ciprofloxacin hydrochloride by TELIGENT on June 9th, 2004.
Summary for CIPROFLOXACIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 26 |
| NDAs: | 27 |
| Finished Product Suppliers / Packagers: | 52 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Clinical Trials: | 243 |
| Patent Applications: | 1,808 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| University College, London | N/A |
| National Institute for Health Research, United Kingdom | N/A |
| University of Alberta | Phase 2 |
Pharmacology for CIPROFLOXACIN HYDROCHLORIDE
| Drug Class | Quinolone Antimicrobial |
ATC Classes for CIPROFLOXACIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CIPROFLOXACIN HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CIPRO | TABLET;ORAL | ciprofloxacin hydrochloride | 019537 |
US Patents and Regulatory Information for CIPROFLOXACIN HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075685-003 | Jun 9, 2004 | DISCN | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Hikma | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076558-002 | Jun 9, 2004 | AB | RX | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Pliva | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076426-002 | Jun 15, 2005 | DISCN | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Teva | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076136-002 | Jun 9, 2004 | DISCN | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
