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
(11 years ago) |
Expired
|
| US5695784 | Flavor-masked pharmaceutical compositions |
Dec, 2014
(11 years ago) |
Expired
|
|
US6136347 (Pediatric) | Flavor-masked pharmaceutical compositions |
Jul, 2013
(13 years ago) |
Expired
|
| US6136347 | Flavor-masked pharmaceutical compositions |
Jan, 2013
(13 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
Clinical Trials
Recent Clinical Trials on Cipro:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia | St. Jude Children's Research Hospital | NA | RECRUITING
(Sep 1, 2026) | PHASE1 |
| Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2 | Major Extremity Trauma Research Consortium | NA | RECRUITING
(Jun 1, 2026) | PHASE3 |
| Antibiotic Prophylaxis for Neurogenic Bladder Botox | University of Alberta | NA | RECRUITING
(May 1, 2026) | PHASE2 |
| A Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia (FOVOCIP) | Fundación para la Investigación Biosanitaria del Principado de Asturias | NA | COMPLETED
(May 1, 2026) | PHASE3 |
| Bacteriophages in Addition to Antibiotics for the Treatment of Patients With Infective Endocarditis | University Clinical Hospital na V.V.Vinogradov (branch of RUDN university na Patrice Lumumba) | NA | RECRUITING
(Mar 1, 2026) | PHASE3 |
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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 16 Oct, 2009 | 09 Dec, 2014 | Deferred | 05 Mar, 2014 | Less |
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 |
| ||
| Lab 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 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 |