Assyro AI

FDA Orange Book · active-ingredient family

Vericiguat

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

Reference-listed drug:VERQUVO · NDA 214377

1

Brand (NDA)

0

Generics (ANDA)

6

Listed patents

6

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
VERQUVORLD×3MSDNDA 214377Jan 19, 2021

Marketing exclusivity (6)

  • D-198New indication / change exclusivity (3 years)

    Jan 21, 2029

    in 2 yr 8 mo

  • NCENew chemical entity exclusivity (5 years)

    Jan 19, 2026

    5 mo ago

  • D-198New indication / change exclusivity (3 years)

    Jan 21, 2029

    in 2 yr 8 mo

  • NCENew chemical entity exclusivity (5 years)

    Jan 19, 2026

    5 mo ago

  • D-198New indication / change exclusivity (3 years)

    Jan 21, 2029

    in 2 yr 8 mo

  • NCENew chemical entity exclusivity (5 years)

    Jan 19, 2026

    5 mo ago

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9993476May 19, 2031in 5 yr
U-3062
8921377May 19, 2031in 5 yr
U-3062
11439642May 19, 2031in 5 yr
U-3062
10736896May 19, 2031in 5 yr
SubstanceProduct
8420656May 19, 2031in 5 yr
SubstanceProduct
9604948Nov 26, 2032in 6 yr 6 mo
SubstanceProductU-3062

Vericiguat — 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.