Details for New Drug Application (NDA): 218591

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NDA 218591 describes ENTRESTO SPRINKLE, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ENTRESTO SPRINKLE profile page.

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.

Summary for 218591

Tradename:	ENTRESTO SPRINKLE
Applicant:	Novartis
Ingredient:	sacubitril; valsartan
Patents:	4

Pharmacology for NDA: 218591

Mechanism of Action	Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors

Suppliers and Packaging for NDA: 218591

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591	NDA	Novartis Pharmaceuticals Corporation	0078-1231	0078-1231-20	60 PELLET in 1 BOTTLE (0078-1231-20)
ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591	NDA	Novartis Pharmaceuticals Corporation	0078-1238	0078-1238-20	60 PELLET in 1 BOTTLE (0078-1238-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, PELLETS;ORAL			Strength	6MG;6MG
Approval Date:	Apr 12, 2024	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 2, 2037	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HEART FAILURE WITH ORAL PELLETS
Patent:	⤷ Get Started Free	Patent Expiration:	Jan 15, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	May 27, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 218591

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-002	Apr 12, 2024	⤷ Get Started Free	⤷ Get Started Free
Novartis	ENTRESTO SPRINKLE	sacubitril; valsartan	CAPSULE, PELLETS;ORAL	218591-001	Apr 12, 2024	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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