ENTRESTO Drug Patent Profile
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When do Entresto patents expire, and what generic alternatives are available?
Entresto is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and forty-five patent family members in forty-one countries.
The generic ingredient in ENTRESTO is sacubitril; valsartan. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
DrugPatentWatch® Generic Entry Outlook for Entresto
Entresto was eligible for patent challenges on July 7, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 9, 2036. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ENTRESTO
International Patents: | 145 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 18 |
Clinical Trials: | 38 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ENTRESTO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENTRESTO |
What excipients (inactive ingredients) are in ENTRESTO? | ENTRESTO excipients list |
DailyMed Link: | ENTRESTO at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for ENTRESTO
Generic Entry Date for ENTRESTO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ENTRESTO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Horng Chen | Phase 1/Phase 2 |
Samsung Medical Center | Phase 2 |
Novartis Pharmaceuticals | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for ENTRESTO
Paragraph IV (Patent) Challenges for ENTRESTO
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ENTRESTO | Tablets | sacubitril; valsartan | 24 mg/26 mg, 49 mg/51 mg 97 mg/103 mg | 207620 | 18 | 2019-07-08 |
US Patents and Regulatory Information for ENTRESTO
ENTRESTO is protected by ten US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ENTRESTO is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ENTRESTO
Sacubitril-valsartan dosage regimen for treating heart failure
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE
Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
Methods of treatment and pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods of treatment and pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods of treatment and pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods of treatment and pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
FDA Regulatory Exclusivity protecting ENTRESTO
NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing
LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-003 | Jul 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-003 | Jul 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-003 | Jul 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ENTRESTO
When does loss-of-exclusivity occur for ENTRESTO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
European Patent Office
Patent: 94283
Estimated Expiration: See Plans and Pricing
Japan
Patent: 76469
Estimated Expiration: See Plans and Pricing
Patent: 18519266
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ENTRESTO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2015526458 | 心房拡大又はリモデリングを特徴とする疾患を治療するためのNEP阻害剤 | See Plans and Pricing |
Taiwan | I554504 | See Plans and Pricing | |
Taiwan | 200803834 | Organic compounds | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ENTRESTO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2340828 | 122021000003 | Germany | See Plans and Pricing | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIPHENYL-4-YL)-METHYL)-VALIN) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANSAEUREETHYLESTER))NA 3 * X H 2 0, WORIN X 0 BIS 3 IST; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
2340828 | 2021C/502 | Belgium | See Plans and Pricing | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3 . X H2O, WAARBIJ X 0 TOT 3 IS; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 (C(2015) 8288) 20151123 |
2340828 | CA 2021 00001 | Denmark | See Plans and Pricing | PRODUCT NAME: SACUBITRIL/VALSARTAN, SOM SACUBITRILVALSARTAN-NATRIUMSALTKOMPLEKS, DVS. ...; REG. NO/DATE: EU/1/15/1058 20151123 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |