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FDA Orange Book · active-ingredient family

Atrasentan hydrochloride

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

Reference-listed drug:VANRAFIA · NDA 219208

1

Brand (NDA)

0

Generics (ANDA)

10

Listed patents

1

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
VANRAFIARLDNOVARTISNDA 219208—Apr 02, 2025

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    Apr 02, 2030

    in 3 yr 10 mo

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8623819Aug 22, 2028in 2 yr 3 mo
U-3980
11874283Feb 18, 2032in 5 yr 9 mo
U-3980
9364458Jul 07, 2034in 8 yr 2 mo
ProductU-3980
10016393Jul 07, 2034in 8 yr 2 mo
Product
12370174Dec 16, 2040in 14 yr 8 mo
U-3980
12121509Dec 16, 2040in 14 yr 8 mo
U-3980
11998526Dec 16, 2040in 14 yr 8 mo
U-3980
11491137Dec 16, 2040in 14 yr 8 mo
U-3980
12521369Feb 23, 2041in 14 yr 11 mo
U-3980
12582631Mar 25, 2043in 17 yr
U-3980

Atrasentan hydrochloride — 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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