Halflytely 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 Oct 22, 2022. Details of Halflytely'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). | |||
| US7291324 | Method of bowel cleansing |
Oct, 2022
(1 year, 9 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 Halflytely's patents.
Latest Legal Activities on Halflytely's Patents
Given below is the list of recent legal activities going on the following patents of Halflytely.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) | 01 Jul, 2021 | US7291324 |
| Correspondence Address Change | 30 Jun, 2021 | US7291324 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 25 Apr, 2019 | US7291324 |
| Change in Power of Attorney (May Include Associate POA) | 19 Nov, 2010 | US7291324 |
| Correspondence Address Change | 16 Nov, 2010 | US7291324 |
| Post Issue Communication - Certificate of Correction | 06 Feb, 2008 | US7291324 |
| Patent Issue Date Used in PTA Calculation | 06 Nov, 2007 | US7291324 |
| Recordation of Patent Grant Mailed | 06 Nov, 2007 | US7291324 |
| Email Notification | 19 Oct, 2007 | US7291324 |
| Issue Notification Mailed | 17 Oct, 2007 | US7291324 |
FDA has granted several exclusivities to Halflytely. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Halflytely, 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 Halflytely.
Exclusivity Information
Halflytely holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Halflytely's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 16, 2013 |
US patents provide insights into the exclusivity only within the United States, but Halflytely 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 Halflytely's family patents as well as insights into ongoing legal events on those patents.
Halflytely's family patents
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Generic Launch
Generic Release Date:
Halflytely's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 22, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Halflytely Generics:
Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride is the generic name for the brand Halflytely. 1 company has already filed for the generic of Halflytely. Check out the entire list of companies who have already received approval for Halflytely's generic
About Halflytely
Halflytely is a drug owned by Braintree Laboratories Inc. It is used for cleansing the colon before a colonoscopy in adults. Halflytely uses Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride as an active ingredient. Halflytely was launched by Braintree in 2010.
Market Authorisation Date:
Halflytely was approved by FDA for market use on 16 July, 2010.
Active Ingredient:
Halflytely uses Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride as the active ingredient. Check out other Drugs and Companies using Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride ingredient
Treatment:
Halflytely is used for cleansing the colon before a colonoscopy in adults.
Dosage:
Halflytely is available in the following dosage forms - tablet, delayed release, for solution form for oral use, for solution, tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION, TABLET, DELAYED RELEASE | Discontinued | ORAL |
| 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | TABLET, DELAYED RELEASE, FOR SOLUTION | Discontinued | ORAL |