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  1. pharmadog
  2. ›drugs
  3. ›Qalsody
drug
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tofersen sodium

Marketedupdated 3mo ago
by $BIIB BIOGEN INC.
Approved
community read0 votes

indications

investigational
ALS

all catalysts(0)

nothing on the calendar yet

Patent cliff

source: FDA Orange Book
first barrier falls
Apr 25, 2028
~1.7 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (3)

  • Apr 1, 2035compositionUS 10385341
  • Apr 1, 2035method-of-use (U-3575)US 10669546
  • Apr 1, 2035method-of-use (U-3575)US 10968453

FDA exclusivities (2)

  • Apr 25, 2030ODE-432Orphan Drug (7y)3.7y
  • Apr 25, 2028NCENew Chemical Entity (5y)1.7y

News(1)

  • Biogen’s targeted ALS treatment is reversing decline in some patients. Can more be helped?
    Three years after Qalsody was approved by the FDA as the first drug to target a genetic cause of ALS, some patients are reporting not only disease stabilization but also improvement of symptoms.
    biospace · 8d ago
brand
Qalsody
generic
tofersen sodium
indication
Amyotrophic Lateral Sclerosis
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 29m ago
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