Assyro AI

FDA Orange Book · active-ingredient family

Tofersen

Tofersen is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:QALSODY · NDA 215887

1

Brand (NDA)

0

Generics (ANDA)

3

Listed patents

2

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
QALSODYRLDBIOGEN MANDA 215887—Apr 25, 2023

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Apr 25, 2028

    in 1 yr 11 mo

  • ODE-432Orphan-drug exclusivity (7 years)

    Apr 25, 2030

    in 3 yr 11 mo

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10968453Apr 01, 2035in 8 yr 11 mo
U-3575
10669546Apr 01, 2035in 8 yr 11 mo
U-3575
10385341Apr 01, 2035in 8 yr 11 mo
SubstanceProduct

Tofersen — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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