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FDA Orange Book · active-ingredient family

Zilucoplan sodium

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

Reference-listed drug:ZILBRYSQ · NDA 216834

1

Brand (NDA)

0

Generics (ANDA)

9

Listed patents

6

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
ZILBRYSQRLD×3UCB INCNDA 216834—Oct 17, 2023

Marketing exclusivity (6)

  • NCENew chemical entity exclusivity (5 years)

    Oct 17, 2028

    in 2 yr 4 mo

  • ODE-446Orphan-drug exclusivity (7 years)

    Oct 17, 2030

    in 4 yr 5 mo

  • NCENew chemical entity exclusivity (5 years)

    Oct 17, 2028

    in 2 yr 4 mo

  • ODE-446Orphan-drug exclusivity (7 years)

    Oct 17, 2030

    in 4 yr 5 mo

  • NCENew chemical entity exclusivity (5 years)

    Oct 17, 2028

    in 2 yr 4 mo

  • ODE-446Orphan-drug exclusivity (7 years)

    Oct 17, 2030

    in 4 yr 5 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11752190Jun 12, 2035in 9 yr 1 mo
ProductU-3735
11014965Jun 12, 2035in 9 yr 1 mo
SubstanceU-3735
10435438Jun 12, 2035in 9 yr 1 mo
SubstanceU-3735
10208089Jun 12, 2035in 9 yr 1 mo
SubstanceU-3735
10106579Jun 12, 2035in 9 yr 1 mo
SubstanceProductU-3735
10835574Jun 12, 2035in 9 yr 1 mo
Product
11535650Jun 12, 2035in 9 yr 1 mo
Product
10562934Jun 12, 2035in 9 yr 1 mo
Substance
11965040Jun 12, 2035in 9 yr 1 mo
Product

Zilucoplan 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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