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Last Updated: December 24, 2024

Details for New Drug Application (NDA): 214012


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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 thirteen 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:13
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214012
Generic Entry Date for 214012*:
Constraining patent/regulatory exclusivity:
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:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)
Approval Date:Dec 22, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 22, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:10,125,369Patent Expiration:Aug 18, 2034Product Flag?YSubstance Flag?YDelist Request?
Patented Use:AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Patent:10,131,907Patent Expiration:Aug 24, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, 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 8,232,383 ⤷  Subscribe
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 10,266,825 ⤷  Subscribe
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 9,708,615 ⤷  Subscribe
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 9,708,610 ⤷  Subscribe
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 11,530,408 ⤷  Subscribe
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 8,546,143 ⤷  Subscribe
Novartis LEQVIO inclisiran sodium SOLUTION;SUBCUTANEOUS 214012-001 Dec 22, 2021 11,078,485 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.