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Last Updated: June 5, 2020

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ENTRESTO Drug 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 six patents protecting this drug.

This drug has ninety-two patent family members in thirty-seven 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.

US ANDA Litigation and 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 November 27, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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

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Drug patent expirations by year for ENTRESTO
Drug Prices for ENTRESTO

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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

SponsorPhase
AbbottN/A
Saint-Louis-Lariboisière University HospitalsN/A
Momentum Research, Inc.N/A

See all ENTRESTO clinical trials

Recent Litigation for ENTRESTO

Identify potential future generic entrants

District Court Litigation
Case NameDate
IN RE: Entresto (Sacubitril/Valsartan) Patent Litigation2019-12-20
NOVARTIS PHARMACEUTICALS CORPORATION v. MACLEODS PHARMACEUTICALS LTD.2019-10-25
Novartis Pharmaceuticals Corporation v. Alembic Pharmaceuticals Limited2019-10-24

See all ENTRESTO litigation

Synonyms for ENTRESTO
3-(1-Biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate
9052AF
AC-29037
ACN-036829
AK198922
C96H120N12Na6O21
D10226
Entresto (TN)
EX-A2849
FT-0700025
LCZ 696
Q27292546
Sacubitril mixture with valsartan
sacubitril valsartan sodium hydrate
Sacubitril valsartan sodium hydrate (JAN)
UNII-WB8FT61183
Valsartan mixture with AHU-377
WB8FT61183
Paragraph IV (Patent) Challenges for ENTRESTO
Tradename Dosage Ingredient NDA Submissiondate
ENTRESTO TABLET;ORAL sacubitril; valsartan 207620 2019-07-08

US Patents and Regulatory Information for ENTRESTO

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   Start Trial   Start Trial   Start Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-003 Jul 7, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-001 Jul 7, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-002 Jul 7, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ENTRESTO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1467728 132016000051059 Italy   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUSI LORO SALI FARMACEUTICAMENTE ACCETTABILI(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058 - C(2015)8288, 20151123
1467728 300811 Netherlands   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
1948158 CA 2016 00023 Denmark   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN SOM SACUBITRIL-VALSARTAN-NATRIUMSALTKOMPLEKS; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
1467728 16C0019 France   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
McKinsey
Johnson and Johnson
Medtronic
Baxter

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