Kerendia is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 2 US drug patents filed from 2024 to 2025 out of which none have expired yet. Kerendia's patents have been open to challenges since 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
(8 years from now) | Active |
| US8436180 | Substituted-4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof |
Aug, 2033
(6 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 |
|---|---|---|
 | ||
| Patent Term Extension Certificate | 02 Jan, 2026 | US8436180 |
| Email Notification | 18 Nov, 2025 | USRE49826 |
| Recordation of Patent eCertificate of Correction | 18 Nov, 2025 | USRE49826 |
| Mail Patent eCofC Notification | 18 Nov, 2025 | USRE49826 |
| Patent eCofC Notification | 18 Nov, 2025 | USRE49826 |
| Post Issue Communication - Certificate of Correction | 30 Oct, 2025 | USRE49826 |
| Email Notification | 16 Jul, 2025 | USRE49826 |
| Mail Patent eCofC Notification | 15 Jul, 2025 | USRE49826 |
| Patent eCofC Notification | 15 Jul, 2025 | USRE49826 |
| Recordation of Patent eCertificate of Correction | 15 Jul, 2025 | USRE49826 |
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 4 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2028. 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 |
| New Indication(I-970) | Jul 11, 2028 |
| New Strength(NS) | Jul 11, 2028 |
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
Clinical Trials
Recent Clinical Trials on Kerendia:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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.
How can I launch a generic of Kerendia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kerendia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kerendia'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 Kerendia -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 02 Feb, 2026 | 29 Jul, 2035 | Less | |||
| 09 Jul, 2025 | 29 Jul, 2035 | High |
About Kerendia
Kerendia is a drug owned by Bayer Healthcare Pharmaceuticals Inc. Kerendia uses Finerenone as an active ingredient. Kerendia was launched by Bayer 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 |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |
| 40MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |