Spinraza patent expiration?

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Spinraza (nusinersen) – Patent Status

Item	Details	Expiry / End Date
Key US Patent(s)	• US 8,722,294 – “Antisense oligonucleotide and method of use for treating spinal muscular atrophy” (filed 2007, granted 2014) • US 9,210,058 – “Method of delivering antisense oligonucleotide to the central nervous system” (filed 2009, granted 2015) • US 9,562,346 – “Pharmacokinetic and formulation methods for nusinersen” (filed 2010, granted 2017)	• 8,722,294: expires 20 yrs from filing → 2027 (filing 2007) • 9,210,058: expires 2029 (filing 2009) • 9,562,346: expires 2030 (filing 2010)
Orphan Drug Exclusivity	Granted by the FDA in 2014 for the treatment of SMA; 7‑year exclusivity period from the date of approval (2016)	End of exclusivity: 2023
Patent Term Extension	No significant term extensions reported for the primary nusinersen patents; standard 20‑year term applies	–
Impact on Generics	Because the main composition‑of‑matter patents and key delivery patents are still active (expiring 2027‑2030), and the FDA exclusivity ended 2023, the drug remains under the protection of the original patents. No generic (biosimilar) has been approved or is in advanced development in the U.S. as of 2024.	–

Spinraza’s core patents will expire between 2027 and 2030.
The FDA’s 7‑year orphan drug exclusivity expired in 2023, so the market is no longer under regulatory exclusivity.
Because the patents are still in force, the drug remains protected and no approved generic version exists.

If you need the most current status (e.g., any recent patent filings or court rulings), you can check the USPTO database or the FDA’s Orange Book.

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