CIPROFLOXACIN Drug Patent Profile
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When do Ciprofloxacin patents expire, and what generic alternatives are available?
Ciprofloxacin is a drug marketed by Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Sentiss, Sun Pharm, Anchen Pharms, Ani Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Rising, Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rubicon, Watson Labs Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms. and is included in fifty-one NDAs.
The generic ingredient in CIPROFLOXACIN is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ciprofloxacin
A generic version of CIPROFLOXACIN was approved as ciprofloxacin hydrochloride by RUBICON on June 9th, 2004.
Summary for CIPROFLOXACIN
| US Patents: | 0 |
| Applicants: | 41 |
| NDAs: | 51 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 123 |
| Clinical Trials: | 297 |
| Patent Applications: | 4,475 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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
Recent Clinical Trials for CIPROFLOXACIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Missouri-Columbia | Phase 4 |
| Sanofi | Phase 1 |
| Institut de Recherches Internationales Servier | Phase 1 |
Pharmacology for CIPROFLOXACIN
| Drug Class | Fluoroquinolone Antibacterial Quinolone Antimicrobial |
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Medical Subject Heading (MeSH) Categories for CIPROFLOXACIN
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
| 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 | 076426-002 | Jun 15, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Baxter Hlthcare Corp | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 078024-001 | Mar 18, 2008 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amneal | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075939-003 | Jun 9, 2004 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Pai Holdings Pharm | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 076754-001 | Jun 9, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
