Ciprodex is a drug owned by Sandoz Inc. It is protected by 6 US drug patents filed from 2013 to 2016. Out of these, 1 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 04, 2025. Details of Ciprodex's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8846650 | Method of treating middle ear infections |
Jun, 2025
(12 days from now) | Active |
| US9402805 | Method of treating middle ear infections |
Sep, 2022
(2 years ago) |
Expired
|
| US9149486 | Method of treating middle ear infections |
Sep, 2022
(2 years ago) |
Expired
|
| US9345714 | Method of treating middle ear infections |
Sep, 2022
(2 years ago) |
Expired
|
| US6284804 | Topical suspension formulations containing ciprofloxacin and dexamethasone |
Aug, 2020
(4 years ago) |
Expired
|
| US6359016 | Topical suspension formulations containing ciprofloxacin and dexamethasone |
Aug, 2020
(4 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ciprodex's patents.
Latest Legal Activities on Ciprodex's Patents
Given below is the list of recent legal activities going on the following patents of Ciprodex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 01 Jul, 2024 | US9345714 |
| Maintenance Fee Reminder Mailed Critical | 15 Jan, 2024 | US9345714 |
| Expire Patent Critical | 13 Nov, 2023 | US9149486 |
| Maintenance Fee Reminder Mailed Critical | 29 May, 2023 | US9149486 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Mar, 2022 | US8846650 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Jan, 2020 | US9402805 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Nov, 2019 | US9345714 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Mar, 2019 | US9149486 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Mar, 2018 | US8846650 |
| Email Notification Critical | 26 Aug, 2016 | US9402805 |
Several oppositions have been filed on Ciprodex's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Ciprodex's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ciprodex patents.
Ciprodex's Oppositions Filed in EPO
Ciprodex has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 21, 2006, by Strawman Limited. This opposition was filed on patent number EP02799587A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP02799587A | Sep, 2006 | STRAWMAN LIMITED | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Ciprodex is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ciprodex's family patents as well as insights into ongoing legal events on those patents.
Ciprodex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ciprodex's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 04, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ciprodex Generic API suppliers:
Ciprofloxacin; Dexamethasone is the generic name for the brand Ciprodex. 4 different companies have already filed for the generic of Ciprodex, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ciprodex's generic
How can I launch a generic of Ciprodex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ciprodex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ciprodex's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ciprodex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.3%/0.1% | 31 Jul, 2012 | 1 | 10 Aug, 2020 | Extinguished |
Alternative Brands for Ciprodex
Ciprodex which is used for treating ear infections., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
About Ciprodex
Ciprodex is a drug owned by Sandoz Inc. It is used for treating ear infections. Ciprodex uses Ciprofloxacin; Dexamethasone as an active ingredient. Ciprodex was launched by Sandoz in 2003.
Approval Date:
Ciprodex was approved by FDA for market use on 18 July, 2003.
Active Ingredient:
Ciprodex uses Ciprofloxacin; Dexamethasone as the active ingredient. Check out other Drugs and Companies using Ciprofloxacin; Dexamethasone ingredient
Treatment:
Ciprodex is used for treating ear infections.
Dosage:
Ciprodex is available in suspension/drops form for otic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.3%;0.1% | SUSPENSION/DROPS | Prescription | OTIC |