Kerendia is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 2 US drug patents filed from 2021 to 2024 out of which none have expired yet. Kerendia's patents will be open to challenges from 09 July, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 29, 2035. Details of Kerendia's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| USRE49826 | Method for the preparation of (4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1-6-naphthyridine-3-carboxamide and the purification thereof for use as an active pharmaceutical ingredient |
Jul, 2035
(10 years from now) | Active |
| US8436180 | Substituted-4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof |
Apr, 2029
(3 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 Kerendia's patents.
Latest Legal Activities on Kerendia's Patents
Given below is the list of recent legal activities going on the following patents of Kerendia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 29 Nov, 2023 | US8436180 |
| Second letter to regulating agency to determine regulatory review period | 20 Oct, 2022 | US8436180 |
| Letter from FDA or Dept of Agriculture re PTE application | 13 Sep, 2022 | US8436180 |
| Patent Term Extension Application under 35 USC 156 Filed | 04 Jan, 2022 | US8436180 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8436180 |
| Email Notification Critical | 06 Dec, 2019 | US8436180 |
| Change in Power of Attorney (May Include Associate POA) Critical | 06 Dec, 2019 | US8436180 |
| Correspondence Address Change Critical | 05 Dec, 2019 | US8436180 |
| Email Notification Critical | 04 Sep, 2018 | US8436180 |
| Change in Power of Attorney (May Include Associate POA) Critical | 04 Sep, 2018 | US8436180 |
FDA has granted several exclusivities to Kerendia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kerendia, 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 Kerendia.
Exclusivity Information
Kerendia holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Kerendia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-279) | Sep 01, 2025 |
| New Chemical Entity Exclusivity(NCE) | Jul 09, 2026 |
US patents provide insights into the exclusivity only within the United States, but Kerendia 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 Kerendia's family patents as well as insights into ongoing legal events on those patents.
Kerendia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kerendia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 29, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kerendia Generics:
There are no approved generic versions for Kerendia as of now.
About Kerendia
Kerendia is a drug owned by Bayer Healthcare Pharmaceuticals Inc. Kerendia uses Finerenone as an active ingredient. Kerendia was launched by Bayer Hlthcare in 2021.
Approval Date:
Kerendia was approved by FDA for market use on 09 July, 2021.
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 Kerendia is 09 July, 2021, its NCE-1 date is estimated to be 09 July, 2025.
Active Ingredient:
Kerendia uses Finerenone as the active ingredient. Check out other Drugs and Companies using Finerenone ingredient
Dosage:
Kerendia is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |