Entresto Sprinkle is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 4 US drug patents filed in 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 02, 2037. Details of Entresto Sprinkle's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| 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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8101659 | Methods of treatment and pharmaceutical composition |
Jan, 2025
(4 months 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
(2 years from now) | Active |
| US10722471 | Galenic formulations of organic compounds |
Feb, 2037
(12 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 Entresto Sprinkle's patents.
Latest Legal Activities on Entresto Sprinkle's Patents
Given below is the list of recent legal activities going on the following patents of Entresto Sprinkle.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Jan, 2024 | US10722471 |
| 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 |
| Patent Term Extension Certificate Critical | 23 Aug, 2021 | US8101659 |
| Withdrawal of Application for PTE Critical | 19 Aug, 2021 | US8877938 |
| Notice of Final Determination -Election Required | 04 Mar, 2021 | US8877938 |
| Notice of Final Determination -Election Required | 04 Mar, 2021 | US8101659 |
| Request for Trial Denied Critical | 16 Feb, 2021 | US8101659 |
| Petition Requesting Trial | 07 Aug, 2020 | US8101659 |
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 Sprinkle and ongoing litigations to help you estimate the early arrival of Entresto Sprinkle generic.
Entresto Sprinkle's Litigations
Entresto Sprinkle has 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 Sprinkle's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8101659 | August, 2020 |
Terminated-Denied
(16 Feb, 2021) | Novartis Pharmaceuticals Corporation | Biocon Pharma Limited |
Several oppositions have been filed on Entresto Sprinkle'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 Sprinkle's generic, the next section provides detailed information on ongoing and past EP oppositions related to Entresto Sprinkle patents.
Entresto Sprinkle's Oppositions Filed in EPO
Entresto Sprinkle 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 |
|---|---|---|---|
| | |||
| 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 Sprinkle 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 Sprinkle's family patents as well as insights into ongoing legal events on those patents.
Entresto Sprinkle's Family Patents
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Generic Launch
Generic Release Date:
Entresto Sprinkle's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 02, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Entresto Sprinkle Generics:
Sacubitril; Valsartan is the generic name for the brand Entresto Sprinkle. 5 different companies have already filed for the generic of Entresto Sprinkle, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Entresto Sprinkle's generic
Entresto Sprinkle Competitors
Understanding your competition is essential for market success. There are several other brand drugs in the same treatment category and using the same active ingredient (Sacubitril; Valsartan) as Entresto Sprinkle. 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 |
| |||||
| Novartis Pharms Corp |
| |||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Sacubitril; Valsartan, Entresto Sprinkle's active ingredient. Check the complete list of approved generic manufacturers for Entresto Sprinkle
About Entresto Sprinkle
Entresto Sprinkle is a drug owned by Novartis Pharmaceuticals Corp. Entresto Sprinkle uses Sacubitril; Valsartan as an active ingredient. Entresto Sprinkle was launched by Novartis in 2024.
Approval Date:
Entresto Sprinkle was approved by FDA for market use on 12 April, 2024.
Active Ingredient:
Entresto Sprinkle uses Sacubitril; Valsartan as the active ingredient. Check out other Drugs and Companies using Sacubitril; Valsartan ingredient
Dosage:
Entresto Sprinkle is available in capsule, pellets form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6MG;6MG | CAPSULE, PELLETS | Prescription | ORAL |
| 15MG;16MG | CAPSULE, PELLETS | Prescription | ORAL |