Drybench Patent.

NUSINERSEN SODIUM, NDA 209531

The patents and exclusivities FDA's Orange Book lists for NDA 209531 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured: 14 October 2026
Paragraph IV list captured: 17 October 2026
Last checked: 30 October 2026
Data-branch commit: dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the app NUSINERSEN SODIUM in the molecule app

Listed protection

Listed dates run from 11 Jul 2027 to 4 Mar 2036, each by its own rule; no one date stands for this product.

Earliest listed date: 11 Jul 2027US 7,838,657, substance patentRule R1 · Product 001 · patent.txt line 10,617
Latest listed date: 4 Mar 2036US 12,013,403, use patentRule R1 · Product 001 · patent.txt line 10,616
Latest substance patent: 23 Dec 2030US 8,361,977, substance and product patentRule R1 · Products 001, 002, 003 · patent.txt lines 10,618, 10,626, 10,633
Latest listed patent: 4 Mar 2036US 12,013,403, use patentRule R1 · Product 001 · patent.txt line 10,616
Latest exclusivity: 27 Mar 2029NS exclusivityRule R3 · Products 002, 003 · exclusivity.txt lines 794–795

28 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 209531, as listed. The sections below name products by these numbers.

Product 001 · SPINRAZA
Dosage form; route
SOLUTION;INTRATHECAL
Strength
EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)
Approval date as listed
23 Dec 2016
Type as listed
RX
Applicant as listed
BIOGEN INC
Product 002 · SPINRAZA
Dosage form; route
SOLUTION;INTRATHECAL
Strength
EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)
Approval date as listed
27 Mar 2026
Type as listed
RX
Applicant as listed
BIOGEN INC
Product 003 · SPINRAZA
Dosage form; route
SOLUTION;INTRATHECAL
Strength
EQ 50MG BASE/5ML (EQ 10MG BASE/ML)
Approval date as listed
27 Mar 2026
Type as listed
RX
Applicant as listed
BIOGEN INC

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

21 entries from 34 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 7,838,657, substance patent
patent.txt line 10,617
Expiry as listed
11 Jul 2027
Rule
R1
Flags
substance
Product numbers
001
US 7,838,657, substance and product patent
patent.txt lines 10,625, 10,632
Expiry as listed
11 Jul 2027
Rule
R1
Flags
substance · product
Product numbers
002, 003
US 9,717,750, use patent
patent.txt lines 10,620, 10,628, 10,635
Expiry as listed
17 Jun 2030
Rule
R1
Flags
use code U-1942
Product numbers
001, 002, 003
US 9,717,750, use patent
patent.txt lines 10,621, 10,629, 10,636
Expiry as listed
17 Jun 2030
Rule
R1
Flags
use code U-1943
Product numbers
001, 002, 003
US 9,717,750, use patent
patent.txt lines 10,622, 10,630, 10,637
Expiry as listed
17 Jun 2030
Rule
R1
Flags
use code U-2093
Product numbers
001, 002, 003
US 9,717,750, use patent
patent.txt lines 10,623, 10,631, 10,638
Expiry as listed
17 Jun 2030
Rule
R1
Flags
use code U-2094
Product numbers
001, 002, 003
US 8,980,853, use patent
patent.txt lines 10,619, 10,627, 10,634
Expiry as listed
24 Nov 2030
Rule
R1
Flags
use code U-1941
Product numbers
001, 002, 003
US 8,361,977, substance and product patent
patent.txt lines 10,618, 10,626, 10,633
Expiry as listed
23 Dec 2030
Rule
R1
Flags
substance · product
Product numbers
001, 002, 003
US 9,926,559, use patent
patent.txt line 10,624
Expiry as listed
9 Jan 2034
Rule
R1
Flags
use code U-1943
Product numbers
001
US 10,436,802, use patent
patent.txt line 10,605
Expiry as listed
11 Sep 2035
Rule
R1
Flags
use code U-1941
Product numbers
001
US 10,436,802, use patent
patent.txt line 10,606
Expiry as listed
11 Sep 2035
Rule
R1
Flags
use code U-1942
Product numbers
001
US 10,436,802, use patent
patent.txt line 10,607
Expiry as listed
11 Sep 2035
Rule
R1
Flags
use code U-1943
Product numbers
001
US 10,436,802, use patent
patent.txt line 10,608
Expiry as listed
11 Sep 2035
Rule
R1
Flags
use code U-1944
Product numbers
001
US 10,436,802, use patent
patent.txt line 10,609
Expiry as listed
11 Sep 2035
Rule
R1
Flags
use code U-2093
Product numbers
001
US 10,436,802, use patent
patent.txt line 10,610
Expiry as listed
11 Sep 2035
Rule
R1
Flags
use code U-2094
Product numbers
001
US 12,013,403, use patent
patent.txt line 10,611
Expiry as listed
4 Mar 2036
Rule
R1
Flags
use code U-1941
Product numbers
001
US 12,013,403, use patent
patent.txt line 10,612
Expiry as listed
4 Mar 2036
Rule
R1
Flags
use code U-1942
Product numbers
001
US 12,013,403, use patent
patent.txt line 10,613
Expiry as listed
4 Mar 2036
Rule
R1
Flags
use code U-1943
Product numbers
001
US 12,013,403, use patent
patent.txt line 10,614
Expiry as listed
4 Mar 2036
Rule
R1
Flags
use code U-1944
Product numbers
001
US 12,013,403, use patent
patent.txt line 10,615
Expiry as listed
4 Mar 2036
Rule
R1
Flags
use code U-2093
Product numbers
001
US 12,013,403, use patent
patent.txt line 10,616
Expiry as listed
4 Mar 2036
Rule
R1
Flags
use code U-2094
Product numbers
001

Listed exclusivities

Each exclusivity FDA lists for NDA 209531, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

NS exclusivity
exclusivity.txt lines 794–795
Date
27 Mar 2029
Rule
R3
Definition
New strength (to be checked against FDA's list)
Product numbers
002, 003

Paragraph IV list rows giving NDA 209531

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 209531, each cell as listed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.

Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 209531

Nusinersen · Intrathecal Solution · 12 mg/5 mL
RLD/NDA as listed: Spinraza 209531
First PIV submission
10 Mar 2026
ANDAs
1
180-day status
blank
Decision posted
blank
First applicant approval
blank
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
4 Mar 2036

Notes from the trace

R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivity How to read the Orange Book data files Paragraph IV certification What changed, by week