Kengreal is a drug owned by Chiesi Usa Inc. It is protected by 10 US drug patents filed from 2015 to 2018. Out of these, 8 drug patents are active and 2 have expired. Kengreal's patents have been open to challenges since 23 June, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 10, 2035. Details of Kengreal'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). | |||
| US9439921 | Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same |
Jul, 2035
(10 years from now) | Active |
| US9700575 | Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same |
Jul, 2035
(10 years from now) | Active |
| US9295687 | Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same |
Jul, 2035
(10 years from now) | Active |
| US10039780 | Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same |
Jul, 2035
(10 years from now) | Active |
| US8680052 | Methods of treating, reducing the incidence of, and/or preventing ischemic events |
Mar, 2033
(8 years from now) | Active |
| US9427448 | Methods of treating, reducing the incidence of, and/or preventing ischemic events |
Nov, 2030
(5 years from now) | Active |
| US9925265 | Methods of treating or preventing stent thrombosis |
May, 2029
(4 years from now) | Active |
| US8759316 | Maintenance of platelet inhibition during antiplatelet therapy |
May, 2029
(4 years from now) | Active |
| US6130208 | Formulation containing a nucleotide analogue |
Jun, 2023
(1 year, 5 months ago) |
Expired
|
| US6114313 | Pharmaceutical compositions for freeze drying |
Dec, 2018
(6 years 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 Kengreal's patents.
Latest Legal Activities on Kengreal's Patents
Given below is the list of recent legal activities going on the following patents of Kengreal.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Mar, 2024 | US9439921 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Feb, 2024 | US9427448 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Sep, 2023 | US9295687 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Feb, 2022 | US10039780 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Dec, 2021 | US8759316 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Sep, 2021 | US9925265 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Jan, 2021 | US9700575 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Mar, 2020 | US9439921 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Feb, 2020 | US9427448 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Sep, 2019 | US9295687 |
FDA has granted several exclusivities to Kengreal. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kengreal, 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 Kengreal.
Exclusivity Information
Kengreal holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Kengreal's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 22, 2020 |
US patents provide insights into the exclusivity only within the United States, but Kengreal 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 Kengreal's family patents as well as insights into ongoing legal events on those patents.
Kengreal's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kengreal's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 10, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kengreal Generics:
There are no approved generic versions for Kengreal as of now.
How can I launch a generic of Kengreal before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kengreal's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kengreal'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 Kengreal -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/vial | 24 Jun, 2019 | 2 | 10 Jul, 2035 |
About Kengreal
Kengreal is a drug owned by Chiesi Usa Inc. Kengreal uses Cangrelor as an active ingredient. Kengreal was launched by Chiesi in 2015.
Approval Date:
Kengreal was approved by FDA for market use on 22 June, 2015.
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 Kengreal is 22 June, 2015, its NCE-1 date is estimated to be 23 June, 2019.
Active Ingredient:
Kengreal uses Cangrelor as the active ingredient. Check out other Drugs and Companies using Cangrelor ingredient
Dosage:
Kengreal is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/VIAL | POWDER | Prescription | INTRAVENOUS |