CIPROFLOXACIN HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for ciprofloxacin hydrochloride and what is the scope of patent protection?
Ciprofloxacin hydrochloride
is the generic ingredient in seven branded drugs marketed by Sandoz, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Key Therap, Depomed Inc, Bayer Hlthcare, 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, Yiling, and Laboratorios Salvat, and is included in thirty-four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are twenty-three drug master file entries for ciprofloxacin hydrochloride. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for CIPROFLOXACIN HYDROCHLORIDE
US Patents: | 1 |
Tradenames: | 7 |
Applicants: | 31 |
NDAs: | 34 |
Drug Master File Entries: | 23 |
Finished Product Suppliers / Packagers: | 56 |
Raw Ingredient (Bulk) Api Vendors: | 110 |
Clinical Trials: | 301 |
Patent Applications: | 4,567 |
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 |
---|---|
Prostate Cancer Foundation | Phase 1/Phase 2 |
Institute of Cancer Research, United Kingdom | Phase 1/Phase 2 |
Shanghai Pulmonary Hospital, Shanghai, China | Phase 4 |
Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 250MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 750MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 500MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Yiling | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 208921-001 | Jun 22, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chartwell | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076896-003 | Nov 4, 2004 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sun Pharm Inds Ltd | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075747-003 | Jun 9, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bayer Hlthcare | CIPRO | ciprofloxacin hydrochloride | TABLET;ORAL | 019537-002 | Oct 22, 1987 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for CIPROFLOXACIN HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | CIPRO | ciprofloxacin hydrochloride | TABLET;ORAL | 019537-004 | Oct 22, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | CILOXAN | ciprofloxacin hydrochloride | OINTMENT;OPHTHALMIC | 020369-001 | Mar 30, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Depomed Inc | PROQUIN XR | ciprofloxacin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021744-001 | May 19, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Depomed Inc | PROQUIN XR | ciprofloxacin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021744-001 | May 19, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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