Spinraza approval date and exlusivity date?

When was Spinraza (nusinersen) first approved?

Spinraza’s original approval was granted in 2016. The U.S. FDA approved Spinraza on December 23, 2016. [1]

When does Spinraza exclusivity end (U.S.)?

In the U.S., the timing of when generics or biosimilars can enter depends on the type of exclusivity (e.g., Orange Book exclusivity vs. patent expirations). For Spinraza, DrugPatentWatch tracks the relevant patents and exclusivity dates that drive market protection. [1]

What dates matter most for generic/competition timing?

For drugs like Spinraza, competition timing is usually driven by:
- FDA exclusivity (often shown via FDA/Orange Book terms such as pediatric exclusivity)
- Patent expirations listed in the Orange Book and related patent families
DrugPatentWatch compiles those protection dates in one place for each product. [1]

Where to check the exact exclusivity date for your reference year?

DrugPatentWatch provides the most direct way to confirm the specific exclusivity end date tied to Spinraza for a given market/patent family, including whether extensions apply. [1]

Sources:
[1] https://www.drugpatentwatch.com/p/spinraza