Clenpiq is a drug owned by Ferring Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2018 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 26, 2034. Details of Clenpiq'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). | |||
| US9827231 | Liquid pharmaceutical composition |
Jun, 2034
(9 years from now) | Active |
| US10624879 | Liquid pharmaceutical composition |
Jun, 2034
(9 years from now) | Active |
| US11191753 | Liquid pharmaceutical composition |
Jun, 2034
(9 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 Clenpiq's patents.
Latest Legal Activities on Clenpiq's Patents
Given below is the list of recent legal activities going on the following patents of Clenpiq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Oct, 2023 | US10624879 |
| Recordation of Patent Grant Mailed Critical | 07 Dec, 2021 | US11191753 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Dec, 2021 | US11191753 |
| Email Notification Critical | 19 Nov, 2021 | US11191753 |
| Issue Notification Mailed Critical | 17 Nov, 2021 | US11191753 |
| Application Is Considered Ready for Issue Critical | 05 Nov, 2021 | US11191753 |
| Dispatch to FDC | 05 Nov, 2021 | US11191753 |
| Issue Fee Payment Verified Critical | 04 Nov, 2021 | US11191753 |
| Issue Fee Payment Received Critical | 04 Nov, 2021 | US11191753 |
| Response to Reasons for Allowance | 04 Nov, 2021 | US11191753 |
FDA has granted several exclusivities to Clenpiq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Clenpiq, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Clenpiq.
Exclusivity Information
Clenpiq holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Clenpiq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Aug 15, 2021 |
US patents provide insights into the exclusivity only within the United States, but Clenpiq 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 Clenpiq's family patents as well as insights into ongoing legal events on those patents.
Clenpiq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Clenpiq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 26, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Clenpiq Generic API suppliers:
Citric Acid; Magnesium Oxide; Sodium Picosulfate is the generic name for the brand Clenpiq. 1 company has already filed for the generic of Clenpiq. Check out the entire list of companies who have already received approval for Clenpiq's generic
How can I launch a generic of Clenpiq before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Clenpiq's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Clenpiq'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 Clenpiq -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 3.5 g, and 12 g | 11 Feb, 2019 | 1 | 26 Jun, 2034 |
Alternative Brands for Clenpiq
Clenpiq which is used for bowel preparation for colonoscopies., has several other brand drugs using the same active ingredient (Citric Acid; Magnesium Oxide; Sodium Picosulfate). 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 | |
|---|---|---|
| Ferring Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Citric Acid; Magnesium Oxide; Sodium Picosulfate, Clenpiq's active ingredient. Check the complete list of approved generic manufacturers for Clenpiq
About Clenpiq
Clenpiq is a drug owned by Ferring Pharmaceuticals Inc. It is used for bowel preparation for colonoscopies. Clenpiq uses Citric Acid; Magnesium Oxide; Sodium Picosulfate as an active ingredient. Clenpiq was launched by Ferring Pharms Inc in 2017.
Approval Date:
Clenpiq was approved by FDA for market use on 28 November, 2017.
Active Ingredient:
Clenpiq uses Citric Acid; Magnesium Oxide; Sodium Picosulfate as the active ingredient. Check out other Drugs and Companies using Citric Acid; Magnesium Oxide; Sodium Picosulfate ingredient
Treatment:
Clenpiq is used for bowel preparation for colonoscopies.
Dosage:
Clenpiq is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12GM/BOT;3.5GM/BOT;10MG/BOT | SOLUTION | Prescription | ORAL |