CIPRODEX Drug Patent Profile
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Which patents cover Ciprodex, and when can generic versions of Ciprodex launch?
Ciprodex is a drug marketed by Sandoz and is included in one NDA.
The generic ingredient in CIPRODEX is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ciprodex
A generic version of CIPRODEX was approved as ciprofloxacin; dexamethasone by DR REDDYS on August 10th, 2020.
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Questions you can ask:
- What is the 5 year forecast for CIPRODEX?
- What are the global sales for CIPRODEX?
- What is Average Wholesale Price for CIPRODEX?
Summary for CIPRODEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 10 |
| Patent Applications: | 77 |
| Drug Prices: | Drug price information for CIPRODEX |
| Drug Sales Revenues: | Drug sales revenues for CIPRODEX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CIPRODEX |
| What excipients (inactive ingredients) are in CIPRODEX? | CIPRODEX excipients list |
| DailyMed Link: | CIPRODEX at DailyMed |
Recent Clinical Trials for CIPRODEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. Paul's Hospital, Canada | Phase 4 |
| Boston Medical Center | Phase 4 |
| Exela Pharma Sciences, LLC. | Phase 3 |
Paragraph IV (Patent) Challenges for CIPRODEX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CIPRODEX | Otic Suspension | ciprofloxacin; dexamethasone | 0.3%/0.1% | 021537 | 1 | 2012-07-31 |
US Patents and Regulatory Information for CIPRODEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ 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 CIPRODEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | 9,345,714 | ⤷ Start Trial |
| Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | 4,844,902 | ⤷ Start Trial |
| Sandoz | CIPRODEX | ciprofloxacin; dexamethasone | SUSPENSION/DROPS;OTIC | 021537-001 | Jul 18, 2003 | 9,402,805 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CIPRODEX
See the table below for patents covering CIPRODEX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 3704907 | ⤷ Start Trial | |
| European Patent Office | 0280915 | ⤷ Start Trial | |
| Japan | S63203629 | LOCALLY APPLICABLE BLEND OF DILASE INHIBITOR COMBINED WITH CORTICOSTEROIDS | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CIPRODEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1429780 | CA 2012 00045 | Denmark | ⤷ Start Trial | |
| 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 |
| 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 |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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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