Home Applications 214012 Application 214012
Type NDA
Sponsor NOVARTIS PHARMS CORP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEQVIO INCLISIRAN INJECTABLE;INJECTION 284MG/1.5ML Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214012-001 LEQVIO INCLISIRAN SODIUM EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22
Orange Book patents# Current patent rows page 1 of 1 · 26 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214012-001 8809292 2027-05-10 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 8809292 2027-05-10 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 8809292 2027-05-10 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 8222222 2027-12-29 U-4249 2022-01-18 N214012-001 8222222 2027-12-29 U-4413 2022-01-18 N214012-001 8222222 2027-12-29 U-4414 2022-01-18 N214012-001 10131907 2028-08-24 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 10131907 2028-08-24 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 10131907 2028-08-24 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 10806791 2028-12-04 Drug substance 2022-01-18 N214012-001 8828956 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 8828956 2028-12-04 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 8828956 2028-12-04 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 9370582 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 9370582 2028-12-04 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 9370582 2028-12-04 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 8106022 2029-12-12 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 8106022 2029-12-12 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 8106022 2029-12-12 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 10125369 2034-08-18 U-4249 Drug substance, Drug product 2022-01-18 N214012-001 10125369 2034-08-18 U-4413 Drug substance, Drug product 2022-01-18 N214012-001 10125369 2034-08-18 U-4414 Drug substance, Drug product 2022-01-18 N214012-001 12460206 2034-08-18 Drug substance, Drug product 2025-11-24 N214012-001 10851377 2036-08-25 U-4249 2022-01-18 N214012-001 10851377 2036-08-25 U-4413 2022-01-18 N214012-001 10851377 2036-08-25 U-4414 2022-01-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214012-001 LEQVIO EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML) SOLUTION / SUBCUTANEOUS RLD, RS 2021-12-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 13 · 515 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N214012-001 8809292 2027-05-10 U-4413 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8809292 2027-05-10 U-4414 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8809292 2027-05-10 U-4249 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8222222 2027-12-29 U-4249 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8222222 2027-12-29 U-4413 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8222222 2027-12-29 U-4414 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10131907 2028-08-24 U-4413 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10131907 2028-08-24 U-4249 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10131907 2028-08-24 U-4414 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10806791 2028-12-04 Drug substance 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8828956 2028-12-04 U-4413 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8828956 2028-12-04 U-4414 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8828956 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 9370582 2028-12-04 U-4413 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 9370582 2028-12-04 U-4414 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 9370582 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8106022 2029-12-12 U-4249 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8106022 2029-12-12 U-4413 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 8106022 2029-12-12 U-4414 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10125369 2034-08-18 U-4413 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10125369 2034-08-18 U-4414 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10125369 2034-08-18 U-4249 Drug substance, Drug product 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 12460206 2034-08-18 Drug substance, Drug product 2025-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10851377 2036-08-25 U-4413 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10851377 2036-08-25 U-4414 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214012-001 10851377 2036-08-25 U-4249 2022-01-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214012-001 8809292 2027-05-10 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 8222222 2027-12-29 U-4249 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 10131907 2028-08-24 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 10806791 2028-12-04 Drug substance 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 8828956 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 9370582 2028-12-04 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 8106022 2029-12-12 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 10125369 2034-08-18 U-4249 Drug substance, Drug product 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 12460206 2034-08-18 Drug substance, Drug product 2025-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214012-001 10851377 2036-08-25 U-4249 2022-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 8809292 2027-05-10 U-4249 Drug substance, Drug product 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 8222222 2027-12-29 U-4249 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 10131907 2028-08-24 U-4249 Drug substance, Drug product 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214012-001 10806791 2028-12-04 Drug substance 2022-01-18 31067a03dcf5…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LEQVIO INCLISIRAN Novartis Pharmaceuticals Corporation 6fc0afca-4513-4c35-b594-6544aee29a44 2026-02-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 214012 application number: NDA214012 ndc (product): 0078-1000
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-1000 LEQVIO inclisiran Novartis Pharmaceuticals Corporation NDA Current 0078-1000 LEQVIO inclisiran Novartis Pharmaceuticals Corporation NDA Current 0078-1000 LEQVIO inclisiran Novartis Pharmaceuticals Corporation NDA Current