Prepopik is a drug owned by Ferring Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 10, 2028. Details of Prepopik'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). | |||
| US8450338 | Granular compositions of sodium picosulphate and potassium bicarbonate and uses thereof |
Oct, 2028
(3 years from now) | Active |
| US8481083 | Granular compositions of magnesium oxide and citric acid and uses thereof |
Oct, 2028
(3 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 Prepopik's patents.
Latest Legal Activities on Prepopik's Patents
Given below is the list of recent legal activities going on the following patents of Prepopik.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 27 Oct, 2022 | US8450338 |
| Correspondence Address Change Critical | 27 Oct, 2022 | US8481083 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Dec, 2020 | US8481083 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Nov, 2020 | US8450338 |
| Mail O.P. Petition Decision | 23 Sep, 2014 | US8450338 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 22 Sep, 2014 | US8450338 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 19 Sep, 2014 | US8450338 |
| O.P. Petition Decision | 18 Sep, 2014 | US8450338 |
| Petition Entered | 25 Jul, 2013 | US8450338 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Jul, 2013 | US8481083 |
FDA has granted several exclusivities to Prepopik. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Prepopik, 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 Prepopik.
Exclusivity Information
Prepopik holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Prepopik's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 16, 2015 |
| New Patient Population(NPP) | Aug 15, 2021 |
US patents provide insights into the exclusivity only within the United States, but Prepopik 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 Prepopik's family patents as well as insights into ongoing legal events on those patents.
Prepopik's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Prepopik's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 10, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prepopik Generic API suppliers:
Citric Acid; Magnesium Oxide; Sodium Picosulfate is the generic name for the brand Prepopik. 1 company has already filed for the generic of Prepopik. Check out the entire list of companies who have already received approval for Prepopik's generic
How can I launch a generic of Prepopik before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prepopik's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prepopik'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 Prepopik -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg, 3.5 g, and 12 g | 21 May, 2014 | 1 | 10 Oct, 2028 | Extinguished |
Alternative Brands for Prepopik
There are several other brand drugs using the same active ingredient (Citric Acid; Magnesium Oxide; Sodium Picosulfate) as Prepopik. 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, Prepopik's active ingredient. Check the complete list of approved generic manufacturers for Prepopik
About Prepopik
Prepopik is a drug owned by Ferring Pharmaceuticals Inc. Prepopik uses Citric Acid; Magnesium Oxide; Sodium Picosulfate as an active ingredient. Prepopik was launched by Ferring Pharms Inc in 2012.
Approval Date:
Prepopik was approved by FDA for market use on 16 July, 2012.
Active Ingredient:
Prepopik 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
Dosage:
Prepopik is available in for solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | Discontinued | ORAL |