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Last Updated: June 25, 2021

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Ciprofloxacin hydrochloride - Generic Drug Details

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What are the generic drug sources for ciprofloxacin hydrochloride and what is the scope of freedom to operate?

Ciprofloxacin hydrochloride is the generic ingredient in seven branded drugs marketed by Novartis, Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Bayer Hlthcare, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell, 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, 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 thirty-four drug master file entries for ciprofloxacin hydrochloride. Fifty-eight 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
University College, LondonN/A
National Institute for Health Research, United KingdomN/A
University of AlbertaPhase 2

See all ciprofloxacin hydrochloride clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Get Started Free  Get Started FreeEQ 750MG BASETABLET;ORAL
  Get Started Free  Get Started FreeEQ 500MG BASETABLET;ORAL
  Get Started Free  Get Started FreeEQ 250MG 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
Paragraph IV (Patent) Challenges for CIPROFLOXACIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CIPRO TABLET;ORAL ciprofloxacin hydrochloride 019537

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
Taro CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076912-001 Feb 18, 2005 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Mylan CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075685-002 Jun 9, 2004 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Teva CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076136-003 Jun 9, 2004 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Hikma CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076558-002 Jun 9, 2004 AB RX No No   Get Started Free   Get Started Free   Get Started Free
>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
Depomed Inc PROQUIN XR ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744-001 May 19, 2005   Get Started Free   Get Started Free
Depomed Inc PROQUIN XR ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744-001 May 19, 2005   Get Started Free   Get Started Free
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-001 Apr 8, 1996   Get Started Free   Get Started Free
Novartis CILOXAN ciprofloxacin hydrochloride OINTMENT;OPHTHALMIC 020369-001 Mar 30, 1998   Get Started Free   Get Started Free
Depomed Inc PROQUIN XR ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744-001 May 19, 2005   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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