Viewing data from:

SPINRAZA

NDA

NUSINERSEN SODIUM | N209531 | BIOGEN INC

3 strengths7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

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

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Spinraza (2023)

Total Spending

$3.1M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$28331.89

Spending Trend

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

YoY Change:+2.2%

5yr CAGR:+1.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

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

SHANDONG ANSHUN PHARMACEUTICAL CO LTDNUSINERSEN SODIUM

DMF 416962025

SHANGHAI SINUOTIDES BIOPHARMACEUTICAL CO LTDNUSINERSEN

DMF 417072025

SHANGHAI SINUOTIDES BIOPHARMACEUTICAL CO LTDNUSINERSEN SODIUM

DMF 423262025

YANGZHOU AURISCO PHARMACEUTICAL CO LTDNUSINERSEN SODIUM

DMF 430922025

SICHUAN GOWELL PHARMACEUTICAL CO LTDNUSINERSEN SODIUM

DMF 432832025

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)

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 patents0 exclusivities▾

SOLUTION;INTRATHECAL | Approved: Mar 27, 2026

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

RLD

4 patents0 exclusivities▾

SOLUTION;INTRATHECAL | Approved: Mar 27, 2026

Change History (6)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Biogen Idec changed its company name to Biogen on the Spinraza (nusinersen sodium) NDA 209531.

Old: BIOGEN IDEC

New: BIOGEN

MODIFIEDApplicant Full Name7/1/2026

Biogen Idec Inc changed its corporate name to Biogen Inc for SPINRAZA (nusinersen sodium) NDA 209531.

Old: BIOGEN IDEC INC

New: BIOGEN INC

MODIFIEDApplicant7/1/2026

Biogen Idec changed its corporate name to Biogen for the Spinraza (nusinersen sodium) NDA 209531.

Old: BIOGEN IDEC

New: BIOGEN

MODIFIEDApplicant7/1/2026

Biogen Idec changed its registered applicant name to Biogen for Spinraza (nusinersen sodium), NDA 209531.

Old: BIOGEN IDEC

New: BIOGEN

MODIFIEDApplicant Full Name7/1/2026

Biogen Idec Inc changed its legal name to Biogen Inc for the Spinraza (nusinersen sodium) NDA 209531.

Old: BIOGEN IDEC INC

New: BIOGEN INC

MODIFIEDApplicant Full Name7/1/2026

Biogen Idec Inc updated its corporate name to Biogen Inc in the Orange Book record for Spinraza (nusinersen sodium) NDA 209531.

Old: BIOGEN IDEC INC

New: BIOGEN INC