Pizensy is a drug owned by Braintree Laboratories Inc. It is protected by 1 US drug patent filed in 2021 out of which none have expired yet. Pizensy's patents have been open to challenges since 13 February, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be May 12, 2037. Details of Pizensy'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). | |||
| US10806743 | Method of administering lactitol to reduce plasma concentration of lactitol |
May, 2037
(12 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 Pizensy's patents.
Latest Legal Activities on Pizensy's Patents
Given below is the list of recent legal activities going on the following patents of Pizensy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 03 Apr, 2024 | US10806743 |
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Jul, 2021 | US10806743 |
| Correspondence Address Change Critical | 30 Jun, 2021 | US10806743 |
| Recordation of Patent Grant Mailed Critical | 20 Oct, 2020 | US10806743 |
| Application ready for PDX access by participating foreign offices Critical | 20 Oct, 2020 | US10806743 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Oct, 2020 | US10806743 |
| Email Notification Critical | 01 Oct, 2020 | US10806743 |
| Issue Notification Mailed Critical | 30 Sep, 2020 | US10806743 |
| Email Notification Critical | 22 Sep, 2020 | US10806743 |
| Mail O.P. Petition Decision | 22 Sep, 2020 | US10806743 |
FDA has granted several exclusivities to Pizensy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pizensy, 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 Pizensy.
Exclusivity Information
Pizensy holds 1 exclusivities. All of its exclusivities have expired in 2025. Details of Pizensy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 12, 2025 |
US patents provide insights into the exclusivity only within the United States, but Pizensy 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 Pizensy's family patents as well as insights into ongoing legal events on those patents.
Pizensy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pizensy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 12, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pizensy Generics:
There are no approved generic versions for Pizensy as of now.
Alternative Brands for Pizensy
Pizensy which is used for treating chronic idiopathic constipation in adult patients., 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 | ||
|---|---|---|---|---|
| Abbvie |
| |||
About Pizensy
Pizensy is a drug owned by Braintree Laboratories Inc. It is used for treating chronic idiopathic constipation in adult patients. Pizensy uses Lactitol as an active ingredient. Pizensy was launched by Braintree Labs in 2020.
Approval Date:
Pizensy was approved by FDA for market use on 12 February, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Pizensy is 12 February, 2020, its NCE-1 date is estimated to be 13 February, 2024.
Active Ingredient:
Pizensy uses Lactitol as the active ingredient. Check out other Drugs and Companies using Lactitol ingredient
Treatment:
Pizensy is used for treating chronic idiopathic constipation in adult patients.
Dosage:
Pizensy is available in for solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10GM | FOR SOLUTION | Discontinued | ORAL |