➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
AstraZeneca
Baxter
Express Scripts
Johnson and Johnson

Last Updated: July 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019537


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 019537 describes CIPRO, which is a drug marketed by Bayer Hlthcare, Novartis, Bayer Pharms, Lupin Ltd, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Anchen Pharms, Ani Pharms Inc, Dr Reddys Labs Ltd, Fosun Pharma, Mylan Pharms Inc, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, Yiling Pharm Ltd, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in fifty-seven NDAs. It is available from one supplier. There are eight patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CIPRO profile page.

The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
Summary for 019537
Tradename:CIPRO
Applicant:Bayer Hlthcare
Ingredient:ciprofloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019537
Suppliers and Packaging for NDA: 019537
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-754 50419-754-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-754-01)
CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-758 50419-758-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-758-01)
Paragraph IV (Patent) Challenges for 019537
Tradename Dosage Ingredient NDA Submissiondate
CIPRO TABLET;ORAL ciprofloxacin hydrochloride 019537

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 8, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Oct 22, 1987TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Oct 22, 1987TE:ABRLD:Yes

Expired US Patents for NDA 019537

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-003 Oct 22, 1987   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-001 Apr 8, 1996   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-002 Oct 22, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Harvard Business School
Colorcon
Dow
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.