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FDA Orange Book · active-ingredient family

Simeprevir sodium

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

Reference-listed drug:OLYSIO · NDA 205123

1

Brand (NDA)

0

Generics (ANDA)

8

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
OLYSIORLDJANSSEN PRODSNDA 205123—Nov 22, 2013

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8349869Jul 28, 2026in 1 mo
SubstanceProductU-1467
8754106Jul 28, 2026in 1 mo
SubstanceU-1467
8741926Jul 28, 2026in 1 mo
SubstanceU-1467
9040562Jul 28, 2026in 1 mo
SubstanceProductU-1467
9856265Jul 28, 2026in 1 mo
SubstanceProductU-1467
9353103Jul 28, 2026in 1 mo
U-1467
9623022Jul 28, 2026in 1 mo
U-1467
8148399Sep 05, 2029in 3 yr 3 mo
SubstanceProductU-1467

Simeprevir sodium — frequently asked questions

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

Agent CTA Background

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