Sacubitril; valsartan - Generic Drug Details

What are the generic drug 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

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

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					Y
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015		RX	Yes	Yes					Y
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015		RX	Yes	No
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-003	Jul 7, 2015		RX	Yes	Yes
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-002	Jul 7, 2015		RX	Yes	No					Y
Novartis Pharms Corp	ENTRESTO	sacubitril; valsartan	TABLET;ORAL	207620-001	Jul 7, 2015		RX	Yes	No					Y

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

International Patents for sacubitril; valsartan

Country	Patent Number	Title	Estimated Expiration
Croatia	P20230480
Japan	6482462
Peru	20190374	COMBINACION FARMACEUTICA DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRA
Norway	340315
Denmark	1948158
South Korea	101432821

Supplementary Protection Certificates for sacubitril; valsartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	PA2016017	Lithuania		PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1467728	SPC/GB16/025	United Kingdom		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
1467728	16C0019	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2340828	PA2021502	Lithuania		PRODUCT NAME: SAKUBITRILAS/VALSARTANAS, KAIP SAKUBITRILO VALSARTANO NATRIO DRUSKOS KOMPLEKSAS, T.Y. (((S)-N-VALERIL-N-((2'-(1H-TETRAZOL-5-IL)-BIFENIL-4-IL)-METIL)-VALINAS)((2R,4S)-5-BIFENIL-4-IL-4-(3-KARBOKSI-PROPIONILAMINO)-2-METIL-PENTANO RUGSTIES ETILO ESTERIS)NA3; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1467728	132016000051059	Italy		PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUSI LORO SALI FARMACEUTICAMENTE ACCETTABILI(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058 - C(2015)8288, 20151123
1948158	300810	Netherlands		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIUM (3-((LS,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 20151123