Assyro AI

FDA Orange Book · active-ingredient family

Tradipitant

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

Reference-listed drug:NEREUS · NDA 220152

1

Brand (NDA)

0

Generics (ANDA)

4

Listed patents

1

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
NEREUSRLDVANDA PHARMS INCNDA 220152—Dec 30, 2025

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    Dec 30, 2030

    in 4 yr 7 mo

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11324735Mar 04, 2036in 9 yr 10 mo
U-4396
10821099Mar 04, 2036in 9 yr 10 mo
U-4396
10772880Mar 04, 2036in 9 yr 10 mo
U-4396
12318375Aug 09, 2036in 10 yr 3 mo
U-4396

Tradipitant — 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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