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FDA Orange Book · active-ingredient family

Vutrisiran sodium

Vutrisiran sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:AMVUTTRA · NDA 215515

1

Brand (NDA)

0

Generics (ANDA)

13

Listed patents

4

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
AMVUTTRARLDALNYLAM PHARMS INCNDA 215515—Jun 13, 2022

Marketing exclusivity (4)

  • I-964New indication exclusivity (3 years)

    Mar 20, 2028

    in 1 yr 9 mo

  • NCENew chemical entity exclusivity (5 years)

    Jun 13, 2027

    in 1 yr

  • ODE-212Orphan-drug exclusivity (7 years)

    Jun 13, 2029

    in 3 yr

  • ODE-527Orphan-drug exclusivity (7 years)

    Mar 20, 2032

    in 5 yr 10 mo

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10131907Aug 24, 2028in 2 yr 3 mo
SubstanceProductU-3396
9370581Dec 04, 2028in 2 yr 6 mo
SubstanceProductU-3396
8828956Dec 04, 2028in 2 yr 6 mo
SubstanceProductU-3396
10806791Dec 04, 2028in 2 yr 6 mo
Substance
8106022Dec 12, 2029in 3 yr 6 mo
SubstanceProductU-3396
9399775Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-3396
10570391Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-3396
11401517Aug 14, 2035in 9 yr 3 mo
SubstanceProductU-3396
10612024Aug 14, 2035in 9 yr 3 mo
SubstanceProductU-3396
11286486Jul 28, 2036in 10 yr 3 mo
SubstanceProductU-3396
10683501Jul 28, 2036in 10 yr 3 mo
SubstanceProductU-3396
10208307Jul 28, 2036in 10 yr 3 mo
SubstanceProductU-3396
12049628Jul 28, 2036in 10 yr 3 mo
SubstanceProductU-3396

Vutrisiran sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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