Suprep Bowel Prep Kit is a drug owned by Braintree Laboratories Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 05, 2027. Details of Suprep Bowel Prep Kit'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). | |||
| US6946149 | Salt solution for colon cleansing |
Mar, 2023
(1 year, 8 months ago) |
Expired
|
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 Suprep Bowel Prep Kit's patents.
Latest Legal Activities on Suprep Bowel Prep Kit's Patents
Given below is the list of recent legal activities going on the following patents of Suprep Bowel Prep Kit.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Jul, 2021 | US6946149 (Litigated) |
| Correspondence Address Change Critical | 30 Jun, 2021 | US6946149 (Litigated) |
| Second letter to regulating agency to determine regulatory review period | 26 Jul, 2016 | US6946149 (Litigated) |
| Mail-Petition Decision - Granted | 19 Mar, 2015 | US6946149 (Litigated) |
| Notice of Final Determination- Ineligible | 18 Mar, 2015 | US6946149 (Litigated) |
| Petition Decision - Granted Critical | 18 Mar, 2015 | US6946149 (Litigated) |
| Petition Entered | 02 May, 2011 | US6946149 (Litigated) |
| Patent Term Extension Application under 35 USC 156 Filed | 02 May, 2011 | US6946149 (Litigated) |
| Letter from FDA or Dept of Agriculture re PTE application | 27 Apr, 2011 | US6946149 (Litigated) |
| Initial letter Re: PTE Application to regulating agency | 21 Jan, 2011 | US6946149 (Litigated) |
FDA has granted several exclusivities to Suprep Bowel Prep Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Suprep Bowel Prep Kit, 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 Suprep Bowel Prep Kit.
Exclusivity Information
Suprep Bowel Prep Kit holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Suprep Bowel Prep Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Aug 05, 2013 |
| Orphan Drug Exclusivity(ODE-315) | Aug 05, 2027 |
US patents provide insights into the exclusivity only within the United States, but Suprep Bowel Prep Kit 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 Suprep Bowel Prep Kit's family patents as well as insights into ongoing legal events on those patents.
Suprep Bowel Prep Kit's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Suprep Bowel Prep Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 05, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Suprep Bowel Prep Kit Generic API suppliers:
Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate is the generic name for the brand Suprep Bowel Prep Kit. 7 different companies have already filed for the generic of Suprep Bowel Prep Kit, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Suprep Bowel Prep Kit's generic
How can I launch a generic of Suprep Bowel Prep Kit before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Suprep Bowel Prep Kit's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Suprep Bowel Prep Kit'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 Suprep Bowel Prep Kit -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 17.5 g/3.13 g/1.6 g | 08 Nov, 2010 | 1 | 23 Feb, 2017 | 07 Mar, 2023 | Eligible |
Alternative Brands for Suprep Bowel Prep Kit
Suprep Bowel Prep Kit which is used for cleansing the colon as preparation for colonoscopy in adults., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||
|---|---|---|---|---|
| Braintree |
| |||
About Suprep Bowel Prep Kit
Suprep Bowel Prep Kit is a drug owned by Braintree Laboratories Inc. It is used for cleansing the colon as preparation for colonoscopy in adults. Suprep Bowel Prep Kit uses Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate as an active ingredient. Suprep Bowel Prep Kit was launched by Braintree Labs in 2010.
Approval Date:
Suprep Bowel Prep Kit was approved by FDA for market use on 05 August, 2010.
Active Ingredient:
Suprep Bowel Prep Kit uses Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate as the active ingredient. Check out other Drugs and Companies using Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate ingredient
Treatment:
Suprep Bowel Prep Kit is used for cleansing the colon as preparation for colonoscopy in adults.
Dosage:
Suprep Bowel Prep Kit is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | SOLUTION | Prescription | ORAL |