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Last Updated: March 28, 2024

SACUBITRIL; VALSARTAN - Generic Drug Details


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What are the generic drug sources for sacubitril; valsartan and what is the scope of patent protection?

Sacubitril; valsartan is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sacubitril; valsartan has one hundred and sixty-two patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for SACUBITRIL; VALSARTAN
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SACUBITRIL; VALSARTAN
Generic Entry Date for SACUBITRIL; VALSARTAN*:
Constraining patent/regulatory exclusivity:
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 SACUBITRIL; VALSARTAN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CardioVascular Research Foundation, KoreaPhase 4
Duk-Woo Park, MDPhase 4
Daewoong Pharmaceutical Co. LTD.Phase 4

See all SACUBITRIL; VALSARTAN clinical trials

Pharmacology for SACUBITRIL; VALSARTAN
Paragraph IV (Patent) Challenges for SACUBITRIL; VALSARTAN
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 SACUBITRIL; VALSARTAN

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

EU/EMA Drug Approvals for SACUBITRIL; VALSARTAN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Novartis Europharm Limited Neparvis sacubitril, valsartan EMEA/H/C/004343
Paediatric heart failureNeparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5.1).Adult heart failureNeparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).
Authorised no no no 2016-05-26
Novartis Europharm Limited Entresto sacubitril, valsartan EMEA/H/C/004062
Paediatric heart failureEntresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction.Adult heart failureEntresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.
Authorised no no no 2015-11-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SACUBITRIL; VALSARTAN

Country Patent Number Title Estimated Expiration
Norway 20043380 ⤷  Try a Trial
Russian Federation 2012107219 ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОТЕНЗИНА И ИНГИБИТОРА NEP ⤷  Try a Trial
European Patent Office 3943084 INHIBITEURS DE NEP POUR LE TRAITEMENT DE MALADIES CARACTÉRISÉES PAR UN AGRANDISSEMENT ATRIAL OU UNE REMODÉLISATION ATRIALE (NEP INHIBITORS FOR TREATING DISEASES CHARACTERIZED BY ATRIAL ENLARGEMENT OR REMODELING) ⤷  Try a Trial
Japan 2015098485 アンギオテンシン受容体遮断剤とNEP阻害剤との医薬組成物 (PHARMACEUTICAL COMBINATIONS OF ANGIOTENSIN RECEPTOR ANTAGONIST AND NEP INHIBITOR) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SACUBITRIL; VALSARTAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1948158 2016C/026 Belgium ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUT COMPLEX, I.E. TRINATRIUM (3-((1S,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONIL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2-(TETRAZOL-5-YLATE)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT)HEMIPENTAHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
1948158 C01948158/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SACUBITRIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
1948158 PA2016017,C1948158 Lithuania ⤷  Try a Trial PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
2340828 CA 2021 00001 Denmark ⤷  Try a Trial 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

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