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Last Updated: March 19, 2024

CIPRO Drug Patent Profile


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Which patents cover Cipro, and when can generic versions of Cipro launch?

Cipro is a drug marketed by Bayer Hlthcare, Sandoz, Bayer Pharms, Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Sentiss, Sun Pharm, Anchen Pharms, Ani Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Rising, Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rubicon, Watson Labs Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms. and is included in fifty-nine NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Paragraph IV (Patent) Challenges for CIPRO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CIPRO Oral Suspension ciprofloxacin 250 mg/5 mL and 500 mg/ 5 mL 020780 1 2009-10-16

US Patents and Regulatory Information for CIPRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075593-003 Jun 9, 2004 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076912-004 Oct 6, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fosun Pharma CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 078712-001 Dec 11, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys CIPROFLOXACIN AND DEXAMETHASONE ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 205548-001 Aug 10, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nostrum Labs CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076138-003 Jun 9, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Farmaceutica CIPROFLOXACIN IN DEXTROSE 5% ciprofloxacin INJECTABLE;INJECTION 076757-001 Apr 21, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 CIPRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CIPRO ciprofloxacin INJECTABLE;INJECTION 019847-001 Dec 26, 1990 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-001 Sep 26, 1997 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-003 Oct 22, 1987 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CIPRO

See the table below for patents covering CIPRO around the world.

Country Patent Number Title Estimated Expiration
Netherlands 930033 ⤷  Try a Trial
South Korea 870001958 ⤷  Try a Trial
Czech Republic 283787 Chuťově maskovaný farmaceutický prostředek (BY MICRO-ENCAPSULATION TASTE-SEQUESTERED PHARMACEUTICAL PREPARATION AND PROCESS FOR PREPARING THEREOF) ⤷  Try a Trial
China 1084188 ⤷  Try a Trial
Hong Kong 1005987 ⤷  Try a Trial
South Africa 8204829 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CIPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 SPC/GB12/058 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1429780 13C0012 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1429780 132013902137451 Italy ⤷  Try a Trial PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780 122012000070 Germany ⤷  Try a Trial PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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