Nexletol is a drug owned by Esperion Therapeutics Inc. It is protected by 10 US drug patents filed from 2020 to 2024. Out of these, 5 drug patents are active and 5 have expired. Nexletol's patents have been open to challenges since 22 February, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 19, 2040. Details of Nexletol'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. | |||
| US11613511 | Methods of making bempedoic acid and compositions of the same |
Jun, 2040
(14 years from now) | Active |
| US7335799 | Hydroxyl compounds and compositions for cholesterol management and related uses |
Dec, 2030
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11760714 | Methods of making bempedoic acid and compositions of the same |
Jun, 2040
(14 years from now) | Active |
| US11926584 | Methods of making bempedoic acid and compositions of the same |
Jun, 2040
(14 years from now) | Active |
| US11744816 | Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease |
Mar, 2036
(10 years from now) | Active |
| US9624152 | Hydroxyl compounds and compositions for cholesterol management and related uses |
Dec, 2023
(1 year, 6 months ago) |
Expired
|
| US10118881 | Hydroxyl compounds and compositions for cholesterol management and related uses |
Dec, 2023
(1 year, 6 months ago) |
Expired
|
| US9000041 | Hydroxyl compounds and compositions for cholesterol management and related uses |
Dec, 2023
(1 year, 6 months ago) |
Expired
|
| US10941095 | Hydroxyl compounds and compositions for cholesterol management and related uses |
Dec, 2023
(1 year, 6 months ago) |
Expired
|
| US8497301 | Hydroxyl compounds and compositions for cholesterol management and related uses |
Dec, 2023
(1 year, 6 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 Nexletol's patents.
Latest Legal Activities on Nexletol's Patents
Given below is the list of recent legal activities going on the following patents of Nexletol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 17 Jun, 2024 | US7335799 |
| Mail O.P. Petition Decision | 17 Jun, 2024 | US7335799 |
| Mail-Record Petition Decision of Granted to Make Entity Status large | 13 Jun, 2024 | US7335799 |
| O.P. Petition Decision | 12 Jun, 2024 | US7335799 |
| Record Petition Decision of Granted to Make Entity Status large | 12 Jun, 2024 | US7335799 |
| Patent Term Extension Certificate Critical | 13 May, 2024 | US7335799 |
| Notice of Final Determination -Eligible | 04 Apr, 2024 | US7335799 |
| Recordation of Patent eGrant | 12 Mar, 2024 | US11926584 |
| Patent eGrant Notification | 12 Mar, 2024 | US11926584 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Mar, 2024 | US11926584 |
FDA has granted several exclusivities to Nexletol. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nexletol, 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 Nexletol.
Exclusivity Information
Nexletol holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Nexletol's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 21, 2025 |
| New Indication(I-943) | Mar 22, 2027 |
| New Indication(I-944) | Mar 22, 2027 |
US patents provide insights into the exclusivity only within the United States, but Nexletol 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 Nexletol's family patents as well as insights into ongoing legal events on those patents.
Nexletol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nexletol's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 19, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nexletol Generics:
There are no approved generic versions for Nexletol as of now.
Alternative Brands for Nexletol
Nexletol which is used for lowering LDL-C in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease., has several other brand drugs in the same treatment category and using the same active ingredient (Bempedoic Acid). 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 | ||
|---|---|---|---|---|
| Esperion Theraps Inc |
| |||
About Nexletol
Nexletol is a drug owned by Esperion Therapeutics Inc. It is used for lowering LDL-C in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. Nexletol uses Bempedoic Acid as an active ingredient. Nexletol was launched by Esperion Theraps Inc in 2020.
Approval Date:
Nexletol was approved by FDA for market use on 21 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 Nexletol is 21 February, 2020, its NCE-1 date is estimated to be 22 February, 2024.
Active Ingredient:
Nexletol uses Bempedoic Acid as the active ingredient. Check out other Drugs and Companies using Bempedoic Acid ingredient
Treatment:
Nexletol is used for lowering LDL-C in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease.
Dosage:
Nexletol is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 180MG | TABLET | Prescription | ORAL |