small molecule

SPINRAZA

NUSINERSEN SODIUM

Loss of exclusivityMarch 2036latest FDA-listed patent expiry
CompanyBiogenSee this company's full patent-cliff portfolio

Drug detail

Brand nameSPINRAZA
Active ingredientNUSINERSEN SODIUM
StrengthEQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)
Dosage formSOLUTION
RouteINTRATHECAL
ModalitySmall molecule
FDA approvalDecember 2016
Marketing statusRX

Listed patents

PatentExpiresType
12013403March 2036use U-2094
10436802September 2035use U-1942
9926559January 2034use U-1943
8361977December 2030substance, product
8980853November 2030use U-1941
9717750June 2030use U-1943
7838657July 2027substance

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

SPINRAZA patent cliff — loss of exclusivity March 2036 | CliffBio