Plenvu is a drug owned by Salix Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2018 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 10, 2033. Details of Plenvu'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). | |||
| US10016504 | Compositions |
Sep, 2033
(8 years from now) | Active |
| US9326969 | Compositions |
Sep, 2033
(8 years from now) | Active |
| US8999313 | Compositions |
Sep, 2033
(8 years from now) | Active |
| US10918723 | Colon cleansing compositions and methods of use |
Sep, 2033
(8 years from now) | Active |
| US12083179 | Colon cleansing compositions and method of use |
Sep, 2033
(8 years from now) | Active |
| US9707297 | Compositions |
Sep, 2033
(8 years from now) | Active |
| US9592252 | Colonoscopy—preparation |
Aug, 2032
(7 years from now) | Active |
| US10646512 | Colonoscopy - preparation |
Mar, 2032
(7 years from now) | Active |
| US10780112 | Colonoscopy-preparation |
Mar, 2032
(7 years from now) | Active |
| US10792306 | Colonoscopy—preparation |
Mar, 2032
(7 years from now) | Active |
| US11529368 | Colonoscopy—preparation |
Mar, 2032
(7 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 Plenvu's patents.
Latest Legal Activities on Plenvu's Patents
Given below is the list of recent legal activities going on the following patents of Plenvu.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Mar, 2024 | US10792306 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Feb, 2024 | US10780112 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Oct, 2023 | US10646512 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Oct, 2023 | US9326969 |
| Recordation of Patent Grant Mailed Critical | 20 Dec, 2022 | US11529368 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Dec, 2022 | US11529368 |
| Email Notification Critical | 01 Dec, 2022 | US11529368 |
| Issue Notification Mailed Critical | 30 Nov, 2022 | US11529368 |
| Dispatch to FDC | 10 Nov, 2022 | US11529368 |
| Application Is Considered Ready for Issue Critical | 10 Nov, 2022 | US11529368 |
FDA has granted several exclusivities to Plenvu. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Plenvu, 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 Plenvu.
Exclusivity Information
Plenvu holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Plenvu's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 04, 2021 |
US patents provide insights into the exclusivity only within the United States, but Plenvu 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 Plenvu's family patents as well as insights into ongoing legal events on those patents.
Plenvu's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Plenvu's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 10, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Plenvu Generic API suppliers:
Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate is the generic name for the brand Plenvu. 2 different companies have already filed for the generic of Plenvu, with Novel Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Plenvu's generic
How can I launch a generic of Plenvu before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Plenvu's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Plenvu'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 Plenvu -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 140 g, 5.2 g, 2.2.g, 48.11 g, 9 g and 7.54 g per pouch | 06 Dec, 2018 | 1 | 10 Sep, 2033 |
Alternative Brands for Plenvu
Plenvu which is used for cleansing the colon in preparation for colonoscopy in adults., has several other brand drugs using the same active ingredient (Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate). 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 | |
|---|---|---|
| Salix Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate, Plenvu's active ingredient. Check the complete list of approved generic manufacturers for Plenvu
About Plenvu
Plenvu is a drug owned by Salix Pharmaceuticals Inc. It is used for cleansing the colon in preparation for colonoscopy in adults. Plenvu uses Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate as an active ingredient. Plenvu was launched by Salix in 2018.
Approval Date:
Plenvu was approved by FDA for market use on 04 May, 2018.
Active Ingredient:
Plenvu uses Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate as the active ingredient. Check out other Drugs and Companies using Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate ingredient
Treatment:
Plenvu is used for cleansing the colon in preparation for colonoscopy in adults.
Dosage:
Plenvu is available in for solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM | FOR SOLUTION | Prescription | ORAL |