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CIPROFLOXACIN; DEXAMETHASONE - Generic Drug Details
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What are the generic sources for ciprofloxacin; dexamethasone and what is the scope of freedom to operate?
Ciprofloxacin; dexamethasone
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Ciprofloxacin; dexamethasone has forty-three patent family members in twenty-two countries.
There are thirty-four drug master file entries for ciprofloxacin; dexamethasone. Three suppliers are listed for this compound.
Summary for CIPROFLOXACIN; DEXAMETHASONE
| International Patents: | 43 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 34 |
| Suppliers / Packagers: | 3 |
| Clinical Trials: | 13 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CIPROFLOXACIN; DEXAMETHASONE |
| DailyMed Link: | CIPROFLOXACIN; DEXAMETHASONE at DailyMed |
Recent Clinical Trials for CIPROFLOXACIN; DEXAMETHASONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
| St. Paul's Hospital, Canada | Phase 4 |
| Spectrum Pharmaceuticals, Inc | Phase 1 |
Recent Litigation for CIPROFLOXACIN; DEXAMETHASONE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ALCON PHARMACEUTICALS LTD. v. DR. REDDYS LABORATORIES, INC. | 2015-07-24 |
| Baker v. Bayer Aktiengescellschaft Corporation | 2010-04-13 |
| Alcon Pharmaceuticals v. Teva Pharmaceuticals | 2009-12-02 |
Pharmacology for CIPROFLOXACIN; DEXAMETHASONE
| Drug Class | Quinolone Antimicrobial Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Paragraph IV (Patent) Challenges for CIPROFLOXACIN; DEXAMETHASONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CIPRODEX | SUSPENSION/DROPS;OTIC | ciprofloxacin; dexamethasone | 021537 | 2012-07-31 |
US Patents and Regulatory Information for CIPROFLOXACIN; DEXAMETHASONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 CIPROFLOXACIN; DEXAMETHASONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CIPROFLOXACIN; DEXAMETHASONE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1231218 | Start Trial |
| Brazil | 0212898 | Start Trial |
| European Patent Office | 1214056 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CIPROFLOXACIN; DEXAMETHASONE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1429780 | CA 2012 00045 | Denmark | Start Trial | |
| 1429780 | SPC/GB12/058 | United Kingdom | Start 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 | Start 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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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 verifification 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.
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