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Spinraza · pharmadog

pharmadog
drugs
Spinraza

drug

patient view →

nusinersen

Marketedupdated 2mo ago

by $BIIB BIOGEN INC.

Approved

annual revenue · 2024–2024peak $1.6B

community read0 votes

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Spinraza

generic

nusinersen

indication

Spinal Muscular Atrophy (SMA)

phase

marketed

approved

2016-12-23

🐶 often sniffed alongside

top 1

tagApproval48 co-mentions · 12 sources

comments(0)

5-min edit window · permanent after that

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no comments yet — first sniff?

Data sources

openFDA · ClinicalTrials.gov

last refreshed 42m ago

Found something off?

🐶 something off?

Report a data issue

Tell Bork what looks wrong — wrong sponsor, stale phase, mislinked ticker, anything. We’ll triage and fix.

Patent cliff

source: FDA Orange Book

first barrier falls

Jul 11, 2027

~1.0 years out

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 83619774.5y
Nov 24, 2030method-of-use (U-1941)US 89808534.4y
Jun 17, 2030method-of-use (U-1943)US 97177503.9y
Jul 11, 2027compositionUS 78386571.0y

Trials studying nusinersen

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
—Observational, Postmarketing Surveillance Study of Spinraza Injection (Nusinersen Sodium)active not recruitingn=74
phase3Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophycompletedn=145
—Adult SMA Research and Clinical Hubrecruitingn=600

more trials →