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Last Updated: May 4, 2024

Sacubitril; valsartan - Generic Drug Details

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What are the generic sources for sacubitril; valsartan and what is the scope of freedom to operate?

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.

Two suppliers are listed for this compound.

Summary for sacubitril; valsartan

International Patents:	162
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	87
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sacubitril; valsartan
DailyMed Link:	sacubitril; valsartan at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sacubitril; valsartan

Generic Entry Date for sacubitril; valsartan^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Sponsor	Phase
Duk-Woo Park, MD	Phase 4
Daewoong Pharmaceutical Co. LTD.	Phase 4
CardioVascular Research Foundation, Korea	Phase 4

See all sacubitril; valsartan clinical trials

Pharmacology for sacubitril; valsartan

Drug Class	Angiotensin 2 Receptor Blocker Neprilysin Inhibitor
Mechanism of Action	Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sacubitril; valsartan

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

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

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Glossary

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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	207620-002	Jul 7, 2015		RX	Yes	No	⤷ 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				⤷ 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			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	207620-002	Jul 7, 2015		RX	Yes	No	⤷ 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				⤷ Try a Trial
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	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

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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

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Country	Patent Number	Title	Estimated Expiration
France	21C1000		⤷ Try a Trial
Israel	237114	מעכבי nep לטיפול במחלות המאופיינות בהגדלת העלייה או שינוי צורני שלה (Nep inhibitors for treating diseases characterized by atrial enlargement or remodeling)	⤷ Try a Trial
Japan	2018519266		⤷ Try a Trial
European Patent Office	3294283		⤷ Try a Trial
Mexico	PA04006917	COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN INHIBIDORES DE VALSARTAN Y ENDOPEPTIDASA NEUTRA. (PHARMACEUTICAL COMPOSITIONS COMPRISING VALSARTAN AND NEP INHIBITORS.)	⤷ Try a Trial
South Korea	20100057704		⤷ Try a Trial
Singapore	10201402055Y	PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sacubitril; valsartan

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1467728	122016000037	Germany	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1467728	300811	Netherlands	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
1467728	SPC/GB16/025	United Kingdom	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/15/1058(NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123
2340828	301088	Netherlands	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, DAT WIL ZEGGEN (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXYPROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3-X H2O, WAARBIJ X 0 TOT EN MET 3 IS; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1948158	93075	Luxembourg	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
1467728	16C0019	France	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1948158	C20160014 00383	Estonia	⤷ Try a Trial	PRODUCT NAME: SAKUBITRIIL/VALSARTAAN;REG NO/DATE: EU/1/15/1058 23.11.2015
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verification 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.