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  1. pharmadog
  2. ›drugs
  3. ›Spinraza
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nusinersen

Marketedupdated 3mo ago
by $BIIB BIOGEN INC.
Approved
annual revenue · 2024–2024peak $1.6B
2024: $1.6B2024$1.6B
community read0 votes

🐶 often sniffed alongside

top 1
  • tagApproval48 co-mentions · 12 sources

all catalysts(0)

nothing on the calendar yet

Trials studying nusinersen

  • —Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)active not recruitingn=74
  • phase2A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophyrecruitingn=52
  • phase1A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)recruitingn=58
  • phase3A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD)active not recruitingn=115
  • phase2A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophycompletedn=25
  • phase4A Study to Learn About the Effect of Nusinersen (BIIB058) Given as Injections to Children With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec (RESPOND)completedn=46
  • phase3Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophycompletedn=145
  • —Adult SMA Research and Clinical Hubrecruitingn=600
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Jul 11, 2027
330 days

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

patents (7)

  • Mar 4, 2036method-of-use (U-2094)US 12013403
  • Sep 11, 2035method-of-use (U-1942)US 10436802
  • Jan 9, 2034method-of-use (U-1943)US 9926559
  • Dec 23, 2030compositionUS 83619774.4y
  • Nov 24, 2030method-of-use (U-1941)US 89808534.3y
  • Jun 17, 2030method-of-use (U-1943)US 97177503.8y
  • Jul 11, 2027compositionUS 7838657330d

News(3)

  • 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 · 4d ago
  • Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology push
    Better-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall Street that they can hit ambitious revenue targets.
    biopharma_dive · 16d ago
  • ‘We have what we need to grow:’ Biogen CEO happy to ease off the M&A for a while
    Biogen's business development team may have been busy in recent years, but CEO Christopher Viehbacher is easing off the acquisitions for a while.
    fiercebiotech · 16d ago
brand
Spinraza
generic
nusinersen
indication
Spinal Muscular Atrophy (SMA)
phase
marketed
approved
2016-12-23
Data sources
openFDA · ClinicalTrials.gov
last refreshed 31m ago
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