Sutab is a drug owned by Braintree Laboratories Inc. It is protected by 4 US drug patents filed from 2021 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 04, 2037. Details of Sutab'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). | |||
| US11382864 | Solid oral sulfate salt formulations for cleansing a colon and methods of using same |
Aug, 2037
(11 years from now) | Active |
| US11033498 | Solid oral sulfate salt formulations for cleaning a colon and methods of using same |
Aug, 2037
(11 years from now) | Active |
| US11638697 | Solid oral sulfate salt formulations for cleaning a colon and methods of using same |
Aug, 2037
(11 years from now) | Active |
| US10143656 | Solid oral sulfate salt formulations for cleaning a colon and methods of using same |
Aug, 2037
(11 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 Sutab's patents.
Latest Legal Activities on Sutab's Patents
Given below is the list of recent legal activities going on the following patents of Sutab.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Miscellaneous Communication to Applicant | 03 May, 2023 | US11638697 |
| Recordation of Patent eGrant | 02 May, 2023 | US11638697 |
| Recordation of Patent Grant Mailed
Critical | 02 May, 2023 | US11638697 |
| Patent Issue Date Used in PTA Calculation
Critical | 02 May, 2023 | US11638697 |
| Miscellaneous Communication to Applicant - No Action Count | 02 May, 2023 | US11638697 |
| Issue Notification Mailed
Critical | 12 Apr, 2023 | US11638697 |
| Application Is Considered Ready for Issue
Critical | 29 Mar, 2023 | US11638697 |
| Dispatch to FDC | 29 Mar, 2023 | US11638697 |
| Issue Fee Payment Received
Critical | 17 Mar, 2023 | US11638697 |
| Issue Fee Payment Verified
Critical | 13 Mar, 2023 | US11638697 |
FDA has granted several exclusivities to Sutab. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Sutab, 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
Sutab.
Exclusivity Information
Sutab holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Sutab's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 10, 2023 |
US patents provide insights into the exclusivity only within the United States, but
Sutab 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 Sutab's family patents as well as insights into
ongoing legal events
on those patents.
Sutab's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sutab's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 04, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sutab Generics:
There are no approved generic versions for Sutab as of now.
How can I launch a generic of Sutab before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sutab's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sutab'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 Sutab -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.479 g/0.225 g/ 0.188 g | 03 Mar, 2023 | 1 | 04 Aug, 2037 |
About Sutab
Sutab is a drug owned by Braintree Laboratories Inc. It is used for preparing the colon for colonoscopy. Sutab uses Magnesium Sulfate; Potassium Chloride; Sodium Sulfate as an active ingredient. Sutab was launched by Braintree Labs in 2020.
Approval Date:
Sutab was approved by FDA for market use on 10 November, 2020.
Active Ingredient:
Sutab uses Magnesium Sulfate; Potassium Chloride; Sodium Sulfate as the active ingredient. Check out other Drugs and Companies using Magnesium Sulfate; Potassium Chloride; Sodium Sulfate ingredient
Treatment:
Sutab is used for preparing the colon for colonoscopy.
Dosage:
Sutab is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.225GM;0.188GM;1.479GM | TABLET | Prescription | ORAL |