Details for New Drug Application (NDA): 214012

NDA 214012 describes LEQVIO, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the LEQVIO profile page.

The generic ingredient in LEQVIO is inclisiran sodium. One supplier is listed for this compound. Additional details are available on the inclisiran sodium profile page.

Summary for 214012

Tradename:	LEQVIO
Applicant:	Novartis
Ingredient:	inclisiran sodium
Patents:	9

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 214012

Constraining patent/regulatory exclusivity:

10,125,369

Dosage:

SOLUTION;SUBCUTANEOUS

^*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.

Suppliers and Packaging for NDA: 214012

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012	NDA	Novartis Pharmaceuticals Corporation	0078-1000	0078-1000-60	1 SYRINGE, GLASS in 1 CARTON (0078-1000-60) / 1.5 mL in 1 SYRINGE, GLASS
LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012	NDA	Novartis Pharmaceuticals Corporation	0078-1000	0078-1000-98	1 SYRINGE, GLASS in 1 CARTON (0078-1000-98) / 1.5 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)
Approval Date:	Dec 22, 2021	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 22, 2026
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	10,125,369	Patent Expiration:	Aug 18, 2034	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Patent:	10,131,907	Patent Expiration:	Aug 24, 2028	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE

Expired US Patents for NDA 214012

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	9,708,610
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	11,078,485
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	9,074,213
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	10,266,825
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	8,232,383
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	9,708,615
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021	11,530,408

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