Suprep Bowel Prep Kit Patent Expiration

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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6946149 Salt solution for colon cleansing
Mar, 2023

(1 year, 4 months ago)

Expired


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

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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

Suprep Bowel Prep Kit has patent protection in a total of 14 countries. It's US patent count contributes only to 6.9% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Suprep Bowel Prep Kit.

Family Patents

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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 Generics:

Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate is the generic name for the brand Suprep Bowel Prep Kit. 4 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




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.

Market Authorisation 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