Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

ENTRESTO Drug Profile

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When do Entresto patents expire, and when can generic versions of Entresto launch?

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 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.

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

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SponsorPhase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 4
Ohio State UniversityPhase 4
University of CopenhagenPhase 4

See all ENTRESTO clinical trials

Recent Litigation for ENTRESTO

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District Court Litigation
Case NameDate
NOVARTIS PHARMACEUTICALS CORPORATION v. MACLEODS PHARMACEUTICALS LTD.2019-10-25

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
AKOS026670199
C96H120N12Na6O21
D10226
Entresto (TN)
FT-0700025
LCZ 696
MolPort-042-624-138
Sacubitril mixture with valsartan
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 207620-001 Jul 7, 2015 RX Yes No   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 Y Y   Start Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-001 Jul 7, 2015 RX Yes No   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
>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 1690021-9 Sweden   Start Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
1948158 122016000038 Germany   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1467728 122016000037 Germany   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Mallinckrodt
Boehringer Ingelheim
McKesson
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.