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Ciprofloxacin - Generic Drug Details
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This ingredient has one hundred and twelve patent family members in eighteen countries.
There are thirty drug master file entries for ciprofloxacin. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for Generic Name: ciprofloxacin
| Tradenames: | 16 |
| Patents: | 17 |
| Applicants: | 45 |
| NDAs: | 61 |
| Drug Master File Entries: see list | 30 |
| Suppliers / Packaging: see list | 10 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: ciprofloxacin
| Ingredient-type | Quinolones |
| Drug Class | Quinolone Antimicrobial |
Tentative approvals for CIPROFLOXACIN
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | TABLET; ORAL | 100MG |
| <disabled> | <disabled> | Tablet; Oral | 100MG |
Clinical Trials for: ciprofloxacin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Claris | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 078024-002 | Mar 18, 2008 | RX | No | ||||||||||||||||||||||
Sun Pharm Inds Ltd | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | TABLET;ORAL | 075747-003 | Jun 9, 2004 | RX | No | ||||||||||||||||||||||
Bedford Labs | CIPROFLOXACIN | ciprofloxacin | INJECTABLE;INJECTION | 076992-002 | Aug 28, 2006 | DISCN | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: ciprofloxacin
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 019857-001 | Dec 26, 1990 | 4,705,789*PED | <disabled> | ||||||||||||||||||||||
Bayer Hlthcare | CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 019857-001 | Dec 26, 1990 | 4,808,583*PED | <disabled> | ||||||||||||||||||||||
Bayer Pharms | CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | ciprofloxacin | INJECTABLE;INJECTION | 019858-001 | Dec 26, 1990 | 4,808,583*PED | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,575,122 | Controlled release auris sensory cell modulator compositions and methods for the treatment of otic disorders | <disabled in preview> | |||||||||||||||||||||||||||
| 9,333,171 | Controlled-release CNS modulating compositions and methods for the treatment of otic disorders | <disabled in preview> | |||||||||||||||||||||||||||
| 8,546,363 | Controlled release corticosteroid compositions and methods for the treatment of otic disorders | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: ciprofloxacin
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taiwan | 200950787 | <disabled in preview> | |||||||||||||||||||||||||||
| China | 103417472 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 5903119 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: CIPROFLOXACIN
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0012 | France | <disabled> | 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 | ||||||||||||||||||||||||||
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