Carospir is a drug owned by Cmp Development Llc. It is protected by 8 US drug patents filed from 2017 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 28, 2036. Details of Carospir'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). | |||
| US9757394 | Spironolactone aqueous formulations |
Oct, 2036
(11 years from now) | Active |
| US11395828 | Spironolactone aqueous compositions |
Oct, 2036
(11 years from now) | Active |
| US10888570 | Spironolactone aqueous compositions |
Oct, 2036
(11 years from now) | Active |
| US11389461 | Spironolactone aqueous compositions |
Oct, 2036
(11 years from now) | Active |
| US10660907 | Spironolactone aqueous compositions |
Oct, 2036
(11 years from now) | Active |
| US10624906 | Spironolactone aqueous compositions |
Oct, 2036
(11 years from now) | Active |
| US10493083 | Spironolactone aqueous compositions |
Oct, 2036
(11 years from now) | Active |
| US11491166 | Spironolactone aqueous compositions |
Oct, 2036
(11 years from now) | Active |
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 Carospir's patents.
Latest Legal Activities on Carospir's Patents
Given below is the list of recent legal activities going on the following patents of Carospir.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Jun, 2024 | US10888570 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Nov, 2023 | US10660907 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Oct, 2023 | US10624906 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 May, 2023 | US10493083 |
| Patent Issue Date Used in PTA Calculation Critical | 08 Nov, 2022 | US11491166 |
| Recordation of Patent Grant Mailed Critical | 08 Nov, 2022 | US11491166 |
| Email Notification Critical | 20 Oct, 2022 | US11491166 |
| Issue Notification Mailed Critical | 19 Oct, 2022 | US11491166 |
| Application Is Considered Ready for Issue Critical | 11 Oct, 2022 | US11491166 |
| Dispatch to FDC | 11 Oct, 2022 | US11491166 |
US patents provide insights into the exclusivity only within the United States, but Carospir 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 Carospir's family patents as well as insights into ongoing legal events on those patents.
Carospir's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Carospir's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 28, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Carospir Generic API suppliers:
Spironolactone is the generic name for the brand Carospir. 22 different companies have already filed for the generic of Carospir, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Carospir's generic
How can I launch a generic of Carospir before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Carospir's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Carospir'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 Carospir -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg/5 mL | 31 Dec, 2020 | 1 | 28 Oct, 2036 |
About Carospir
Carospir is a drug owned by Cmp Development Llc. It is used for managing edema in cirrhotic patients and treating heart failure with reduced ejection fraction to increase survival and reduce hospitalizations. Carospir uses Spironolactone as an active ingredient. Carospir was launched by Cmp Dev Llc in 2017.
Approval Date:
Carospir was approved by FDA for market use on 04 August, 2017.
Active Ingredient:
Carospir uses Spironolactone as the active ingredient. Check out other Drugs and Companies using Spironolactone ingredient
Treatment:
Carospir is used for managing edema in cirrhotic patients and treating heart failure with reduced ejection fraction to increase survival and reduce hospitalizations.
Dosage:
Carospir is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG/5ML | SUSPENSION | Prescription | ORAL |