Viewing data from:

QALSODY

NDA

TOFERSEN | N215887 | BIOGEN MA INC

1 strength3 unique patents2 unique exclusivities

Patent Timeline

3 unique patents, 2 exclusivities by expiration date

Active (3)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

10385341

Apr. 1, 2035

10669546

Apr. 1, 2035

10968453

Apr. 1, 2035

NCE

Apr. 25, 2028

ODE-432

Apr. 25, 2030

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Tofersen in Non-SOD1 ALS NCT07294144	Phase 2	Recruiting	Washington University School of Medicine	30	2025-12-29 → 2028-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Qalsody (2023)

Total Spending

$454K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$976.47

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/15ML (6.7MG/ML)

RLD

3 patents2 exclusivities▴

SOLUTION;INTRATHECAL | Approved: Apr 25, 2023

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10385341	Apr 1, 2035	—	Yes	Yes	—	—
10669546	Apr 1, 2035	—	—	—		—
10968453	Apr 1, 2035	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Apr 25, 2028	Active
ODE-432	Apr 25, 2030	Active