Home Applications 215887 Application 215887
Type NDA
Sponsor BIOGEN MA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QALSODY TOFERSEN SOLUTION;INTRATHECAL 100MG/15ML (6.7MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N215887-001 QALSODY TOFERSEN 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 N215887-001 10968453 2035-04-01 U-3575 2023-05-18
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215887-001 NCE 2028-04-25 N215887-001 ODE-432 2030-04-25
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 2026-02-19 14:30 UTC 2026-02 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215887-001 QALSODY 100MG/15ML (6.7MG/ML) SOLUTION / INTRATHECAL RLD, RS 2023-04-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 66 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215887-001 10669546 2035-04-01 U-3575 2023-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215887-001 10968453 2035-04-01 U-3575 2023-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215887-001 10385341 2035-04-01 Drug substance, Drug product 2023-05-18 8072bd15b7f6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 44 observed states.
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.
Documents# Document, Submission type, Date table Document Submission type Date 74346 ORIG 2023-05-22 74081 ORIG 2023-04-27 74069 ORIG 2023-04-27