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Last Updated: November 24, 2024

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.

Recent Clinical Trials for CIPROFLOXACIN HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Prostate Cancer FoundationPhase 1/Phase 2
Institute of Cancer Research, United KingdomPhase 1/Phase 2
Shanghai Pulmonary Hospital, Shanghai, ChinaPhase 4

See all CIPROFLOXACIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 250MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 750MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 500MG BASETABLET;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

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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