Nusinersen
Overview
Nusinersen is an antisense oligonucleotide used in the treatment of spinal muscular atrophy (SMA) by increasing the expression of functional survival motor neuron (SMN) protein. It works by modulating splicing of the SMN2 gene.
API suppliers (2)
Suppliers of Nusinersen evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
- SHANGHAI SINUOTIDES BIOPHARMACEUTICAL CO LTDChina1 active DMF
- CHONGQING CARELIFE PHARMACEUTICAL CO LTDChina1 active DMF
Patent & exclusivity (US)
Per the FDA Orange Book (3 approved US products), the latest listed US patent on Nusinersen expires 4 Mar 2036 and exclusivity 27 Mar 2029. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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