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 three branded drugs marketed by Novartis, Novartis Pharms Corp, Alembic, Alkem Labs Ltd, Biocon Pharma, Crystal, Laurus, MSN, Torrent, and Zydus Pharms, and is included in ten NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Five suppliers are listed for this compound.

Summary for sacubitril; valsartan

International Patents:	181
US Patents:	12
Tradenames:	3
Applicants:	10
NDAs:	10
Finished Product Suppliers / Packagers:	5
Clinical Trials:	91
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sacubitril; valsartan
DailyMed Link:	sacubitril; valsartan at DailyMed

Recent Clinical Trials for sacubitril; valsartan

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

Sponsor	Phase
Dr. Reddy's Laboratories (Thailand) Limited	Phase 1
Universidade do Porto	Phase 4
Unidade de Investigação e Desenvolvimento Cardiovascular (UnIC)	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	207620-001	Jul 7, 2015	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Crystal	SACUBITRIL AND VALSARTAN	sacubitril; valsartan	TABLET;ORAL	213605-002	May 28, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	SACUBITRIL AND VALSARTAN	sacubitril; valsartan	TABLET;ORAL	213682-003	May 28, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Austria	370732		⤷ Sign Up
Taiwan	200803834	Organic compounds	⤷ Sign Up
Brazil	0306907		⤷ Sign Up
>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	1690021-9	Sweden	⤷ Sign Up	PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
1948158	C20160014 00383	Estonia	⤷ Sign Up	PRODUCT NAME: SAKUBITRIIL/VALSARTAAN;REG NO/DATE: EU/1/15/1058 23.11.2015
1948158	PA2016017,C1948158	Lithuania	⤷ Sign Up	PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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