CIPROFLOXACIN - Generic Drug Details
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What are the generic drug sources for ciprofloxacin and what is the scope of freedom to operate?
Ciprofloxacin
is the generic ingredient in seventeen branded drugs marketed by Bayer Hlthcare, Chartwell, Alk Abello, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Sandoz, Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rising, Rubicon, Watson Labs Inc, Wraser Pharms, Depomed Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Laboratorios Salvat, Anchen Pharms, Ani Pharms, Fosun Pharma, Sentiss, and Sun Pharm, and is included in sixty-five NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Ciprofloxacin has one hundred and fifty patent family members in twenty countries.
There are thirty-four drug master file entries for ciprofloxacin. Five suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for CIPROFLOXACIN
International Patents: | 150 |
US Patents: | 10 |
Tradenames: | 17 |
Applicants: | 48 |
NDAs: | 65 |
Drug Master File Entries: | 34 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 123 |
Clinical Trials: | 297 |
Patent Applications: | 7,194 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for CIPROFLOXACIN |
Drug Sales Revenues: | Drug sales revenues for CIPROFLOXACIN |
What excipients (inactive ingredients) are in CIPROFLOXACIN? | CIPROFLOXACIN excipients list |
DailyMed Link: | CIPROFLOXACIN at DailyMed |
Recent Clinical Trials for CIPROFLOXACIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Missouri-Columbia | Phase 4 |
Sanofi | Phase 1 |
Servier Bio-Innovation LLC | Phase 1 |
Generic filers with tentative approvals for CIPROFLOXACIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | EQ 500MG BASE | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | EQ 250MG BASE | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | EQ 750MG 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
Drug Class | Fluoroquinolone Antibacterial Quinolone Antimicrobial |
Mechanism of Action | Cytochrome P450 1A2 Inhibitors |
Medical Subject Heading (MeSH) Categories for CIPROFLOXACIN
Paragraph IV (Patent) Challenges for CIPROFLOXACIN
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 CIPROFLOXACIN
Expired US Patents for CIPROFLOXACIN
International Patents for CIPROFLOXACIN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2011528716 | ⤷ Try a Trial | |
Canada | 2732686 | COMPOSITIONS DE MODULATEUR DE CELLULES SENSORIELLES AURICULAIRES A LIBERATION CONTROLEE ET PROCEDES DE TRAITEMENT DE TROUBLES OTIQUES (CONTROLLED RELEASE AURIS SENSORY CELL MODULATOR COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTIC DISORDERS) | ⤷ Try a Trial |
Japan | 6014069 | ⤷ Try a Trial | |
Taiwan | I450732 | ⤷ Try a Trial | |
European Patent Office | 2299979 | COMPOSITIONS ANTIMICROBIENNES À LIBÉRATION CONTRÔLÉE ET PROCÉDÉS POUR LE TRAITEMENT DE TROUBLES OTIQUES (CONTROLLED RELEASE ANTIMICROBIAL COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTIC DISORDERS) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2018053173 | ⤷ Try a Trial | |
Australia | 2019275578 | Sterilization of ciprofloxacin composition | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CIPROFLOXACIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 | 132013902137451 | Italy | ⤷ Try a Trial | PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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