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SPINRAZA

NDA

NUSINERSEN SODIUM | N209531 | BIOGEN INC

3 strengths7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (6)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Jul. 11, 2027

Dec. 23, 2030

Nov. 24, 2030

Jun. 17, 2030

Jan. 9, 2034

Sep. 11, 2035

Mar. 4, 2036

Mar. 27, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Biogen MA Inc. et al v. Somerset Therapeutics, LLC et al 1:2026cv00580 3 patentsANDA 221418nusinersen	D. Del.	2026-05-20	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$86688.93

Highest Price

$145663.94

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64406-0058-01SPINRAZA 12MG/5ML VIAL	$145663.94	FSS	Biogen U.S. Corporation	09/14/2026
64406-0058-01SPINRAZA 12MG/5ML VIAL	$86688.93	Big4	Biogen U.S. Corporation	09/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Spinraza (2024)

Total Spending

$3.4M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$28221.54

Spending Trend

$9.1M(2019)→$5.6M(2020)→$2.8M(2021)→$2.6M(2022)→$3.1M(2023)→$3.4M(2024)

YoY Change:-0.4%

5yr CAGR:+0.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

NATCO PHARMA LTDNUSINERSEN SODIUM

DMF 411532026

SHANDONG ANSHUN PHARMACEUTICAL CO LTDNUSINERSEN SODIUM

DMF 416962025

SHANGHAI SINUOTIDES BIOPHARMACEUTICAL CO LTDNUSINERSEN

DMF 417072025

CHONGQING CARELIFE PHARMACEUTICAL CO LTDNUSINERSEN SODIUM, NON-STERILE BULK DRUG SUBSTANCE

DMF 422512025

SHANGHAI SINUOTIDES BIOPHARMACEUTICAL CO LTDNUSINERSEN SODIUM

DMF 423262025

YANGZHOU AURISCO PHARMACEUTICAL CO LTDNUSINERSEN SODIUM

DMF 430922025

SICHUAN GOWELL PHARMACEUTICAL CO LTDNUSINERSEN SODIUM

DMF 432832025

SYNTHON BVNUSINERSEN SODIUM

DMF 435832026

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Mar 31, 2026	SUPPL -16	View Letter (PDF)
Apr 12, 2024	SUPPL -14	View Letter (PDF)
Apr 12, 2024	SUPPL -13	View Letter (PDF)
Feb 21, 2023	SUPPL -11	View Letter (PDF)
Jun 17, 2020	SUPPL -10	View Letter (PDF)
Jun 18, 2019	SUPPL -7	View Letter (PDF)
Jun 17, 2019	SUPPL -8	View Letter (PDF)
Oct 15, 2018	SUPPL -5	View Letter (PDF)
May 16, 2018	SUPPL -4	View Letter (PDF)
May 16, 2018	SUPPL -3	View Letter (PDF)
Nov 27, 2017	SUPPL -2	View Letter (PDF)
Dec 23, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)

RLD

7 patents0 exclusivities▴

SOLUTION;INTRATHECAL | Approved: Dec 23, 2016

Patents (7) · 18 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7838657	Jul 11, 2027	—	Yes	—	—	—
8361977	Dec 23, 2030	—	Yes	Yes	—	—
8980853	Nov 24, 2030	—	—	—		—
9717750	Jun 17, 2030	—	—	—		—
9926559	Jan 9, 2034	—	—	—		—
10436802	Sep 11, 2035	—	—	—		—
12013403	Mar 4, 2036	—	—	—		—

#002 — EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)

RLD

4 patents1 exclusivity▾

SOLUTION;INTRATHECAL | Approved: Mar 27, 2026

#003 — EQ 50MG BASE/5ML (EQ 10MG BASE/ML)

RLD

4 patents1 exclusivity▾

SOLUTION;INTRATHECAL | Approved: Mar 27, 2026

Change History (2)

Recent changes detected for this application.

ADDED7/14/2026

Biogen's SPINRAZA (nusinersen sodium) received a new non-statutory exclusivity designation expiring Mar 2029 under NDA 209531.

New: SPINRAZA (NUSINERSEN SODIUM) — exclusivity NS exp 03/27/2029

ADDED7/14/2026

Biogen's SPINRAZA (nusinersen sodium) gained narrow therapeutic use exclusivity expiring Mar 2029, as recorded in the Orange Book.

New: SPINRAZA (NUSINERSEN SODIUM) — exclusivity NS exp 03/27/2029