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 ten patents protecting this drug. Additional details are available on the LEQVIO profile page.
The generic ingredient in LEQVIO is inclisiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the inclisiran sodium profile page.
The generic ingredient in LEQVIO is inclisiran sodium. There is one drug master file entry for this compound. 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: | 10 |
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: | 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: | Feb 12, 2033 | ||||||||
| Regulatory Exclusivity Use: | AS AN ADJUNCT TO DIET AND EXERCISE TO REDUCE LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) IN PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH) | ||||||||
| Regulatory Exclusivity Expiration: | Feb 12, 2029 | ||||||||
| Regulatory Exclusivity Use: | INDICATED AS AN ADJUNCT TO DIET AND EXERCISE TO REDUCE LDL-C IN PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA | ||||||||
| Regulatory Exclusivity Expiration: | Dec 22, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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 | 10,266,825 | ⤷ Start Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | 8,546,143 | ⤷ Start Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | 9,074,213 | ⤷ Start Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | 8,232,383 | ⤷ Start Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | 10,669,544 | ⤷ Start Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | 10,590,418 | ⤷ Start Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | 11,078,485 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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