Entresto is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 16 US drug patents filed from 2015 to 2021. Out of these, 10 drug patents are active and 6 have expired. Entresto's patents have been open to challenges since 01 April, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be May 09, 2036. Details of Entresto'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. | |||
| US8877938 | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations |
May, 2027
(2 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). | |||
| US11058667 | Sacubitril-valsartan dosage regimen for treating heart failure |
May, 2036
(11 years from now) | Active |
| US11135192 | Inhibitors for treating diseases characterized by atrial enlargement or remodeling |
Aug, 2033
(8 years from now) | Active |
| US9517226 | Inhibitors for treating diseases characterized by atrial enlargement or remodeling |
Aug, 2033
(8 years from now) | Active |
| US9937143 | Inhibitors for treating diseases characterized by atrial enlargement or remodeling |
Aug, 2033
(8 years from now) | Active |
|
US8877938 (Pediatric) | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations |
Nov, 2027
(3 years from now) | Active |
|
US9388134 (Pediatric) | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations |
May, 2027
(2 years from now) | Active |
| US9388134 | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations |
Nov, 2026
(1 year, 11 months from now) | Active |
|
US8101659 (Pediatric) | Methods of treatment and pharmaceutical composition |
Jul, 2025
(7 months from now) | Active |
| US8101659 | Methods of treatment and pharmaceutical composition |
Jan, 2025
(a month from now) | Active |
|
US7468390 (Pediatric) | Methods of treatment and pharmaceutical composition |
May, 2024
(5 months ago) |
Expired
|
| US7468390 | Methods of treatment and pharmaceutical composition |
Nov, 2023
(11 months ago) |
Expired
|
|
US8796331 (Pediatric) | Methods of treatment and pharmaceutical composition |
Jul, 2023
(1 year, 4 months ago) |
Expired
|
|
US8404744 (Pediatric) | Methods of treatment and pharmaceutical composition |
Jul, 2023
(1 year, 4 months ago) |
Expired
|
| US8404744 | Methods of treatment and pharmaceutical composition |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
| US8796331 | Methods of treatment and pharmaceutical composition |
Jan, 2023
(1 year, 10 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 Entresto's patents.
Latest Legal Activities on Entresto's Patents
Given below is the list of recent legal activities going on the following patents of Entresto.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 May, 2024 | US9517226 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Dec, 2023 | US9388134 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Jul, 2023 | US8101659 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2022 | US8877938 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Jan, 2022 | US8796331 |
| Post Issue Communication - Certificate of Correction | 18 Jan, 2022 | US9517226 |
| Post Issue Communication - Certificate of Correction | 18 Jan, 2022 | US9937143 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Oct, 2021 | US11135192 |
| Recordation of Patent Grant Mailed Critical | 05 Oct, 2021 | US11135192 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Sep, 2021 | US9937143 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Entresto and ongoing litigations to help you estimate the early arrival of Entresto generic.
Entresto's Litigations
Entresto been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 07, 2020, against patent number US8101659. The petitioner Biocon Pharma Limited, challenged the validity of this patent, with Novartis Pharmaceuticals Corporation as the respondent. Click below to track the latest information on how companies are challenging Entresto's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8101659 | August, 2020 |
Terminated-Denied
(16 Feb, 2021) | Novartis Pharmaceuticals Corporation | Biocon Pharma Limited |
FDA has granted some exclusivities to Entresto. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Entresto, 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 Entresto.
Exclusivity Information
Entresto holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Entresto's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 07, 2020 |
| New Patient Population(NPP) | Oct 01, 2022 |
| Pediatric Exclusivity(PED) | Apr 01, 2023 |
| M(M-82) | Feb 16, 2024 |
Several oppositions have been filed on Entresto's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Entresto's generic, the next section provides detailed information on ongoing and past EP oppositions related to Entresto patents.
Entresto's Oppositions Filed in EPO
Entresto has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 21, 2008, by Mundipharma Gmbh. This opposition was filed on patent number EP03704413A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP13750725A | Jan, 2022 | Algemeen Octrooi- en Merkenbureau B.V. | Revoked |
| EP13750725A | Jan, 2022 | STADA Arzneimittel AG | Revoked |
| EP13750725A | Jan, 2022 | Generics [UK] Limited | Revoked |
| EP13750725A | Jan, 2022 | Teva Pharmaceutical Industries Ltd | Revoked |
| EP13750725A | Jan, 2022 | Wuesthoff & Wuesthoff Patentanwälte PartG mbB | Revoked |
| EP13750725A | Jan, 2022 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Revoked |
| EP10176094A | Apr, 2021 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP10176094A | Apr, 2021 | Krka, d.d., Novo mesto | Granted and Under Opposition |
| EP10176094A | Apr, 2021 | betapharm Arzneimittel GmbH | Granted and Under Opposition |
| EP10176094A | Apr, 2021 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP10176094A | Apr, 2021 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP10176094A | Apr, 2021 | D Young & Co LLP | Granted and Under Opposition |
| EP10176094A | Apr, 2021 | Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi | Granted and Under Opposition |
| EP10176094A | Jan, 2021 | Generics [UK] Limited | Granted and Under Opposition |
| EP06827689A | Oct, 2014 | Maiwald Patentanwalts GmbH | Revoked |
| EP03704413A | May, 2008 | Mundipharma GmbH | Opposition procedure closed |
US patents provide insights into the exclusivity only within the United States, but Entresto 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 Entresto's family patents as well as insights into ongoing legal events on those patents.
Entresto's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Entresto:
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. Entresto(Sacubitril; Valsartan) has 1 clinical trial that has been verified in 2024. Out of these 1, 1 trial is in PHASE4.
Generic Launch
Generic Release Date:
Entresto's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 09, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Entresto Generic API suppliers:
Sacubitril; Valsartan is the generic name for the brand Entresto. 9 different companies have already filed for the generic of Entresto, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Entresto's generic
How can I launch a generic of Entresto before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Entresto's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Entresto'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 Entresto -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 24 mg/26 mg, 49 mg/51 mg 97 mg/103 mg | 08 Jul, 2019 | 18 | 27 May, 2027 |
Alternative Brands for Entresto
Entresto which is used for treating heart failure with reduced ejection fraction in patients not taking ACE inhibitors or ARBs, or previously on low doses, by titrating up from half the usual starting dose., has several other brand drugs in the same treatment category and using the same active ingredient (Sacubitril; Valsartan). 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 | ||||
|---|---|---|---|---|---|---|
| Azurity |
| |||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Sacubitril; Valsartan. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Novartis |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Sacubitril; Valsartan, Entresto's active ingredient. Check the complete list of approved generic manufacturers for Entresto
About Entresto
Entresto is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating heart failure with reduced ejection fraction in patients not taking ACE inhibitors or ARBs, or previously on low doses, by titrating up from half the usual starting dose. Entresto uses Sacubitril; Valsartan as an active ingredient. Entresto was launched by Novartis Pharms Corp in 2015.
Approval Date:
Entresto was approved by FDA for market use on 07 July, 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 Entresto is 07 July, 2015, its NCE-1 date is estimated to be 01 April, 2022.
Active Ingredient:
Entresto uses Sacubitril; Valsartan as the active ingredient. Check out other Drugs and Companies using Sacubitril; Valsartan ingredient
Treatment:
Entresto is used for treating heart failure with reduced ejection fraction in patients not taking ACE inhibitors or ARBs, or previously on low doses, by titrating up from half the usual starting dose.
Dosage:
Entresto is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 49MG;51MG | TABLET | Prescription | ORAL |
| 24MG;26MG | TABLET | Prescription | ORAL |
| 97MG;103MG | TABLET | Prescription | ORAL |