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FDA Orange Book · active-ingredient family

Vadadustat

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

Reference-listed drug:VAFSEO · NDA 215192

1

Brand (NDA)

0

Generics (ANDA)

14

Listed patents

3

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
VAFSEORLD×3AKEBIANDA 215192—Mar 27, 2024

Marketing exclusivity (3)

  • NCENew chemical entity exclusivity (5 years)

    Mar 27, 2029

    in 2 yr 10 mo

  • NCENew chemical entity exclusivity (5 years)

    Mar 27, 2029

    in 2 yr 10 mo

  • NCENew chemical entity exclusivity (5 years)

    Mar 27, 2029

    in 2 yr 10 mo

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8940773Jun 26, 2027in 1 yr
U-3876
RE47437Jun 26, 2027in 1 yr
SubstanceProduct
8598210Jun 26, 2027in 1 yr
SubstanceProduct
8343952Aug 14, 2027in 1 yr 2 mo
SubstanceProduct
7811595Mar 13, 2028in 1 yr 9 mo
SubstanceProduct
8323671Apr 03, 2028in 1 yr 10 mo
U-3876
12569474Jun 04, 2034in 8 yr 1 mo
U-3876
11857543Jun 09, 2034in 8 yr 1 mo
U-3876
11065237Nov 14, 2034in 8 yr 6 mo
SubstanceProductU-3876
9987262Nov 14, 2034in 8 yr 6 mo
U-3876
9701636Nov 14, 2034in 8 yr 6 mo
SubstanceProduct
10149842Nov 14, 2034in 8 yr 6 mo
SubstanceProduct
11844756Mar 31, 2036in 9 yr 11 mo
U-3876
11324734Mar 31, 2036in 9 yr 11 mo
Product

Vadadustat — 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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