CIPROFLOXACIN HYDROCHLORIDE Drug Patent Profile
Which patents cover Ciprofloxacin Hydrochloride, and what generic alternatives are available?
Ciprofloxacin Hydrochloride is a drug marketed by Altaire Pharms Inc, Fdc Ltd, J Molner, Pharmobedient, Rising, Rubicon Research, The J Molner, Watson Labs Inc, Alembic Therap, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, and Cosette Pharms Nc. and is included in twenty-nine NDAs.
The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride; hydrocortisone. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride; hydrocortisone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ciprofloxacin Hydrochloride
A generic version of CIPROFLOXACIN HYDROCHLORIDE was approved as ciprofloxacin hydrochloride; hydrocortisone by COSETTE PHARMS NC on November 10th, 2025.
AI Deep Research
Questions you can ask:
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Summary for CIPROFLOXACIN HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 27 |
| NDAs: | 29 |
| Finished Product Suppliers / Packagers: | 51 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 327 |
| Patent Applications: | 4,141 |
| 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 |
|---|---|
| Faiz ur rahman | NA |
| Stanford University | EARLY_PHASE1 |
| Uppsala University | PHASE4 |
Pharmacology for CIPROFLOXACIN HYDROCHLORIDE
| Drug Class | Fluoroquinolone Antibacterial Quinolone Antimicrobial |
| Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CIPROFLOXACIN HYDROCHLORIDE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nostrum Labs | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076138-002 | Jun 9, 2004 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hikma | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076558-003 | Jun 9, 2004 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Rising | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075817-003 | Jun 9, 2004 | AB | RX | 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 |

