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FDA Orange Book · active-ingredient family

Difelikefalin acetate

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

Reference-listed drug:KORSUVA · NDA 214916

1

Brand (NDA)

0

Generics (ANDA)

12

Listed patents

1

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
KORSUVARLDVIFOR INTLNDA 214916—Aug 23, 2021

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    Aug 23, 2026

    in 2 mo

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10793596Nov 12, 2027in 1 yr 5 mo
SubstanceProductU-3204
10138270Nov 12, 2027in 1 yr 5 mo
U-3204
10017536Nov 12, 2027in 1 yr 5 mo
SubstanceU-3204
9359399Nov 12, 2027in 1 yr 5 mo
U-3204
9334305Nov 12, 2027in 1 yr 5 mo
U-3204
8536131Nov 12, 2027in 1 yr 5 mo
SubstanceProductU-3204
8486894Nov 12, 2027in 1 yr 5 mo
U-3204
8236766Nov 12, 2027in 1 yr 5 mo
U-3204
8217007Nov 12, 2027in 1 yr 5 mo
U-3204
7727963Nov 12, 2027in 1 yr 5 mo
SubstanceProductU-3204
7713937Nov 12, 2027in 1 yr 5 mo
SubstanceProductU-3204
7402564Nov 12, 2032in 6 yr 6 mo
SubstanceProductU-3204

Difelikefalin acetate — 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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