Cipro is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 09, 2015. Details of Cipro'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). | |||
|
US5695784 (Pediatric) | Flavor-masked pharmaceutical compositions |
Jun, 2015
(9 years ago) |
Expired
|
| US5695784 | Flavor-masked pharmaceutical compositions |
Dec, 2014
(9 years ago) |
Expired
|
|
US6136347 (Pediatric) | Flavor-masked pharmaceutical compositions |
Jul, 2013
(11 years ago) |
Expired
|
| US6136347 | Flavor-masked pharmaceutical compositions |
Jan, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Cipro 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 Cipro's family patents as well as insights into ongoing legal events on those patents.
Cipro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cipro's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 09, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cipro Generic API suppliers:
Ciprofloxacin is the generic name for the brand Cipro. 11 different companies have already filed for the generic of Cipro, with Hikma Farmaceutica having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cipro's generic
How can I launch a generic of Cipro before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cipro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cipro'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 Cipro -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 250 mg/5 mL and 500 mg/ 5 mL | 16 Oct, 2009 | 1 | 05 Mar, 2014 | 09 Dec, 2014 | Deferred |
Alternative Brands for Cipro
Cipro which is used for treating a variety of approved disease indications., has several other brand drugs using the same active ingredient (Ciprofloxacin). 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.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Alk Abello |
| ||
| Bayer Hlthcare |
| ||
| Depomed Inc |
| ||
| Laboratorios Salvat |
| ||
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ciprofloxacin, Cipro's active ingredient. Check the complete list of approved generic manufacturers for Cipro
About Cipro
Cipro is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for treating a variety of approved disease indications. Cipro uses Ciprofloxacin as an active ingredient. Cipro was launched by Bayer Hlthcare in 1997.
Approval Date:
Cipro was approved by FDA for market use on 26 September, 1997.
Active Ingredient:
Cipro uses Ciprofloxacin as the active ingredient. Check out other Drugs and Companies using Ciprofloxacin ingredient
Treatment:
Cipro is used for treating a variety of approved disease indications.
Dosage:
Cipro is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG/5ML | FOR SUSPENSION | Prescription | ORAL |
| 500MG/5ML | FOR SUSPENSION | Prescription | ORAL |