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CIPROFLOXACIN HYDROCHLORIDE Drug Profile
When do Ciprofloxacin Hydrochloride patents expire, and what generic alternatives are available?
Ciprofloxacin Hydrochloride is a drug marketed by Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell Molecules, 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 Pharm Ltd. 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. Sixty-one suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.
Summary for CIPROFLOXACIN HYDROCHLORIDE
Recent Clinical Trials for CIPROFLOXACIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen, LP | Phase 3 |
| Universitaire Ziekenhuizen Leuven | Phase 3 |
| Germans Trias i Pujol Hospital | N/A |
Recent Litigation for CIPROFLOXACIN HYDROCHLORIDE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| In re: Depomed, Inc. | 2015-12-30 |
| Purdue Pharma L.P. v. Depomed, Inc. | 2015-09-15 |
| Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-15 |
See all CIPROFLOXACIN HYDROCHLORIDE litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Endo Pharmaceutical Inc. | 2014-04-17 |
| Purdue Pharma L.P. | 2014-01-24 |
Pharmacology for CIPROFLOXACIN HYDROCHLORIDE
| Drug Class | Quinolone Antimicrobial |
Synonyms for CIPROFLOXACIN HYDROCHLORIDE
| 0MP32MFP6C |
| 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid HCl |
| 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride |
| 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid monohydrochloride |
| 1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)-1,4-dihydro-3-quinolinecarboxylic acid hydrochloride |
| 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride |
| 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride(1:x) |
| 1-Cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-1,4-dihydro-quinoline-3-carboxylic acid; hydrochloride |
| 1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-quinoline-3-carboxylic acid hydrochloride |
| 1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic acid hydrochloride |
| 1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic acid;hydrochloride |
| 1-cyclopropyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid, ch loride |
| 3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, hydrochloride |
| 3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, monohydrochloride |
| 3-Quinolinecarboxylic acid, 1,4-dihydro-1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)-, hydrochloride |
| 4-(3-Carboxy-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-quinolin-7-yl)-piperazin-1-ium; chloride |
| 86483-48-9 |
| 93107-08-5 |
| 9311AF |
| AC-23972 |
| AC1L1Y6P |
| AC1Q3E6U |
| AK126819 |
| AK176012 |
| AKOS005111008 |
| AN-35553 |
| API0002028 |
| ARONIS24122 |
| AX8035163 |
| BAY-o 9867 |
| BAY-O-9867 |
| Bay-o-9867 monohydrate |
| BBC/258 |
| BCP13634 |
| BCP14336 |
| BG0142 |
| BIM-0048462.P001 |
| C17H18FN3O3.HCl |
| Cambridge id 5807784 |
| CAS-93107-08-5 |
| Cetraxal |
| CHEBI:310388 |
| CHEMBL1202 |
| Ciloxan |
| Cipro |
| Ciprofloxacin HCl |
| CIPROFLOXACIN HCL/LACTATE |
| ciprofloxacin hydrochloride (anh.) |
| ciprofloxacin hydrochloride (anhydrous) |
| Ciprofloxacin Hydrochloride Anhydrous |
| Ciprofloxacin monohydrochloride |
| ciprofloxacine hydrochloride |
| CS-8134 |
| DIOIOSKKIYDRIQ-UHFFFAOYSA-N |
| DSSTox_CID_27768 |
| DSSTox_GSID_47788 |
| DSSTox_RID_82545 |
| DTXSID1047788 |
| Epitope ID:174846 |
| F0001-2378 |
| FT-0623850 |
| FT-0623851 |
| GP9406 |
| HMS1568G08 |
| HY-B0356A |
| KB-218801 |
| KS-000046JK |
| KS-5012 |
| LS-141564 |
| MolPort-002-338-774 |
| NCGC00016959-01 |
| NCGC00016959-06 |
| NSC-620634 |
| NSC620634 |
| Prestwick_67 |
| Q-200860 |
| SBB080619 |
| SC-12658 |
| SCHEMBL42310 |
| Tox21_110712 |
| Tox21_110712_1 |
| UNII-0MP32MFP6C |
| Z-0831 |
| ZX-AS004472 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Hikma | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076558-002 | Jun 9, 2004 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Pliva | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076426-002 | Jun 15, 2005 | 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 |
