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Ciprofloxacin - Generic Drug Details
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What are the generic sources for ciprofloxacin and what is the scope of ciprofloxacin patent protection?
Ciprofloxacin
is the generic ingredient in sixteen branded drugs marketed by Bayer Hlthcare, Lupin Ltd, Otonomy Inc, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Novartis Pharms Corp, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms Inc, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Ani Pharms Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Yiling Pharm Ltd, Laboratorios Salvat, Actavis Labs Fl Inc, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty-three NDAs. There are fifteen 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 twenty-eight patent family members in nineteen countries.
There are thirty-one drug master file entries for ciprofloxacin. Ten suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for ciprofloxacin
| International Patents: | 128 |
| US Patents: | 15 |
| Tradenames: | 16 |
| Applicants: | 47 |
| NDAs: | 63 |
| Drug Master File Entries: | 31 |
| Suppliers / Packagers: | 10 |
| Bulk Api Vendors: | 86 |
| Clinical Trials: | 189 |
| Patent Applications: | 6,875 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ciprofloxacin |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ciprofloxacin |
| DailyMed Link: | ciprofloxacin at DailyMed |
Pharmacology for ciprofloxacin
| Ingredient-type | Quinolones |
| Drug Class | Quinolone Antimicrobial |
Medical Subject Heading (MeSH) Categories for ciprofloxacin
Synonyms for ciprofloxacin
| 1-Cyclopropyl-6-fluoro-1,4-dihydro 4-oxo-7-[1-piperazinyl)-quinoline-3-carboxylic Acid |
| 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7- (1-piperazinyl)-3-quinoline-carboxylic acid |
| 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3- quinolinecarboxylic acid |
| 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid |
| 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid |
| 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-quinoline -3-carboxylic acid |
| 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-quinoline-3-carboxylic acid |
| 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)quinoline-3-carboxylic acid |
| 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperzinyl)-3-quinolinecarboxylic acid HCl H2O |
| 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1piperazinyl)-3quinolinecarboxylic acid |
| 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(piperazin-1-yl)-quinoline-3-carboxylic acid |
| 1-Cyclopropyl-6-fluoro-1,4-dihydro-7-(1-piperazinyl)-4-oxo-3-quinoline carboxylic acid |
| 1-Cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)-1,4-dihydro-3-quinolinecarboxylic acid |
| 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid |
| 1-Cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-1,4-dihydro-quinoline-3-carboxylic acid |
| 1-CYCLOPROPYL-6-FLUORO-4-OXO-7-PIPERAZIN-1-YL-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID |
| 1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-quinoline-3-carboxylic acid |
| 1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic acid |
| 1-cyclopropyl-6-fluoro-4-oxo-7-piperazinylhydroquinoline-3-carboxylic acid |
| 1-Cyclopropyl-6-fluoro-7-(4-methyl-piperazin-1-yl)-4-oxo-1,4-dihydro-quinoline-3-carboxylic acid |
| 1-cyclopropyl-6-fluoro-7-(piperazin-1-yl)-1,4-dihydro-4-oxoquinoline-3-carboxylic acid |
| 1-cyclopropyl-6-fluoro-7-hexahydro-1-pyrazinyl-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid |
| 3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- |
| 3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, hydrochloride |
| 3-Quinolinecarboxylic acid, 1,4-dihydro-1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)- |
| 3-Quinolinecarboxylic acid,1,4-dihydro-1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl) |
| 3-Quinolinecarboxylicacid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- |
| 5E8K9I0O4U |
| 721C331 |
| 85721-33-1 |
| A-8526 |
| AB0011928 |
| AB1009412 |
| AC-7613 |
| AC1L1EEW |
| AJ-08409 |
| AK163192 |
| AKOS000269653 |
| ALBB-015909 |
| Alcon Cilox |
| AN-8829 |
| ARONIS020379 |
| AuriPro |
| AuriPro? |
| Bacquinor |
| Baflox |
| BAS 06989041 |
| Bay 09867 |
| Bay o 9867 |
| Bay o 9867 (*Hydrochloride*) |
| BAY q 3939 |
| Bay-09867 |
| BAY-o 9867 |
| BAY-Q-3939 |
| Baycip |
| BAYQ3939 |
| BBL005612 |
| BC203729 |
| BDBM21690 |
| Bernoflox |
| Bi-Cipro |
| BIDD:GT0205 |
| Bio-0540 |
| BPBio1_000140 |
| BRD-K04804440-311-02-3 |
| BRN 3568352 |
| BSPBio_000126 |
| BSPBio_003344 |
| C05349 |
| C17H18FN3O3 |
| CAS-93107-08-5 |
| CBMicro_048498 |
| CCG-39345 |
| CCRIS 5241 |
| Cetraxal |
| CHEBI:100241 |
| CHEMBL8 |
| Ciflox |
| Cifloxin |
| Cilab |
| Ciloxan |
| Ciloxan (*Hydrochloride*) |
| Ciplus |
| Ciprecu |
| Ciprine |
| Ciprinol |
| Cipro |
| Cipro (*Hydrochloride*) |
| Cipro (TN) |
| Cipro I.V. |
| CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER |
| CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Cipro IV |
| Cipro XL |
| Cipro XR |
| Ciprobay |
| Ciprobay Uro |
| Ciprocinol |
| Ciprodar |
| Ciproflox |
| ciprofloxacillin |
| Ciprofloxacin (Cipro) |
| Ciprofloxacin (JP17/USP/INN) |
| Ciprofloxacin [USAN:INN:BAN] |
| Ciprofloxacin [USAN:USP:INN:BAN] |
| Ciprofloxacin dihydrochloride |
| CIPROFLOXACIN EXTENDED RELEASE |
| Ciprofloxacin Hydrchloride |
| Ciprofloxacin In Dextrose 5% |
| Ciprofloxacin In Dextrose 5% In Plastic Container |
| Ciprofloxacin intratympanic - Otonomy |
| Ciprofloxacin monohydrochloride |
| Ciprofloxacin, >=98.0% (HPLC) |
| Ciprofloxacin, Antibiotic for Culture Media Use Only |
| Ciprofloxacin, European Pharmacopoeia (EP) Reference Standard |
| Ciprofloxacin, pharmaceutical secondary standard; traceable to USP and PhEur |
| Ciprofloxacin, United States Pharmacopeia (USP) Reference Standard |
| Ciprofloxacin, VETRANAL(TM), analytical standard |
| Ciprofloxacina |
| Ciprofloxacine |
| Ciprofloxacine [INN-French] |
| Ciprofloxacino |
| Ciprofloxacino [INN-Spanish] |
| Ciprofloxacinum |
| Ciprofloxacinum [INN-Latin] |
| Ciprogis |
| Ciprolin |
| Ciprolon |
| Cipromycin |
| Ciproquinol |
| Ciprowin |
| Ciproxan |
| Ciproxin |
| Ciproxina |
| Ciproxine |
| Ciriax |
| Citopcin |
| Cixan |
| Corsacin |
| CPD000471901 |
| CPF |
| CPFX |
| CS-2410 |
| CTK3E8144 |
| Cycin |
| Cyprobay |
| D00186 |
| D03IHU |
| D0JW1A |
| DB00537 |
| DivK1c_000095 |
| DR001566 |
| DTXSID8022824 |
| Eni |
| Fimoflox |
| Flociprin |
| FT-0601635 |
| HE397506 |
| HMS1922E18 |
| HMS2090O07 |
| HMS2093I03 |
| HMS500E17 |
| HSDB 6987 |
| HY-B0356 |
| IDI1_000095 |
| Ipiflox |
| Italnik |
| J10137 |
| KB-117181 |
| KB-152640 |
| KBio1_000095 |
| KBio2_000642 |
| KBio2_003210 |
| KBio2_005778 |
| KBio3_002846 |
| KBioGR_001567 |
| KBioSS_000642 |
| KS-000002BQ |
| KS-00004C43 |
| KS-5006 |
| Linhaliq |
| Linhaliq [Liposomal Formulation] |
| Loxan |
| LS-141563 |
| MCULE-8631780654 |
| MFCD00185755 |
| MLS001336035 |
| MLS006011837 |
| MolPort-000-819-654 |
| MYSWGUAQZAJSOK-UHFFFAOYSA-N |
| NCGC00016959-01 |
| NCGC00016959-02 |
| NCGC00016959-03 |
| NCGC00016959-04 |
| NCGC00016959-05 |
| NCGC00016959-07 |
| NCGC00095058-01 |
| NCGC00095058-02 |
| NCGC00178128-01 |
| NINDS_000095 |
| NSC-758467 |
| NSC620634 |
| NSC758467 |
| Oprea1_008239 |
| Oprea1_313572 |
| Otiprio |
| OTO-201 |
| Pharmakon1600-01503614 |
| Prestwick0_000113 |
| Prestwick1_000113 |
| Prestwick2_000113 |
| Prestwick3_000113 |
| Probiox |
| Proflaxin |
| Proksi 250 |
| Proksi 500 |
| Quinolid |
| Quintor |
| Rancif |
| Roxytal |
| s2027 |
| SAM002264604 |
| SBB012554 |
| SBI-0048462.P003 |
| SC-17889 |
| SCHEMBL2900 |
| Septicide |
| SMP1_000125 |
| SMR000471901 |
| Sophixin Ofteno |
| SPBio_001474 |
| SPBio_002065 |
| Spectrum_000162 |
| SPECTRUM1503614 |
| Spectrum2_001567 |
| Spectrum3_001872 |
| Spectrum4_000874 |
| Spectrum5_001089 |
| Spitacin |
| SR-05000001863 |
| SR-05000001863-3 |
| ST024751 |
| ST24046329 |
| STK021082 |
| Superocin |
| TX-017484 |
| Unex |
| UNII-5E8K9I0O4U |
| Velmonit |
| Velomonit |
| Z56933707 |
| ZINC20220 |
| Zumaflox |
Tentative approvals for CIPROFLOXACIN
| Applicant | Application No. | Strength | Dosage Form |
| ➤ Try a Free Trial | ➤ Try a Free Trial | EQ 750MG BASE | TABLET;ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | EQ 500MG BASE | TABLET;ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | EQ 250MG BASE | TABLET;ORAL |
US Patents and Regulatory Information for ciprofloxacin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unique Pharm Labs | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076639-001 | Sep 10, 2004 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Depomed Inc | PROQUIN XR | ciprofloxacin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021744-001 | May 19, 2005 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Actavis Labs Fl Inc | CIPROFLOXACIN EXTENDED RELEASE | ciprofloxacin; ciprofloxacin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 077417-001 | Nov 30, 2010 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Teva | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 076136-002 | Jun 9, 2004 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for ciprofloxacin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-002 | Sep 26, 1997 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Bayer Pharms | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 019858-001 | Dec 26, 1990 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Bayer Hlthcare | CIPRO | ciprofloxacin | FOR SUSPENSION;ORAL | 020780-001 | Sep 26, 1997 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Bayer Pharms | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 019858-001 | Dec 26, 1990 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for ciprofloxacin
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,030,297 | Controlled release corticosteroid compositions and methods for the treatment of OTIC disorders | ➤ Try a Free Trial |
| 8,349,353 | Controlled release cytotoxic agent compositions and methods for the treatment of otic disorders | ➤ Try a Free Trial |
| 8,399,018 | Controlled release ion channel modulator compositions and methods for the treatment of otic disorders | ➤ Try a Free Trial |
| 8,496,957 | Controlled release auris sensory cell modulator compositions and methods for the treatment of otic disorders | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for ciprofloxacin
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Mexico | 2011000545 | ➤ Try a Free Trial |
| United Kingdom | 0907065 | ➤ Try a Free Trial |
| Taiwan | 201004633 | ➤ Try a Free Trial |
| South Korea | 20160029870 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ciprofloxacin
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB12/058 | United Kingdom | ➤ Try a Free 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 |
| C0012 | France | ➤ Try a Free 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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