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FDA Orange Book · active-ingredient family

Pazopanib hydrochloride

Pazopanib hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VOTRIENT · NDA 022465

1

Brand (NDA)

6

Generics (ANDA)

0

Listed patents

1

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
VOTRIENTRLD×2NOVARTISNDA 022465ABOct 19, 2009

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
PAZOPANIB HYDROCHLORIDETORRENTANDA 219922Sep 04, 2025
PAZOPANIB HYDROCHLORIDEEUGIA PHARMAANDA 219034ABDec 04, 2024
PAZOPANIB HYDROCHLORIDENOVUGENANDA 218231ABApr 23, 2024
PAZOPANIB HYDROCHLORIDEAPOTEXANDA 217713ABOct 19, 2023
PAZOPANIB HYDROCHLORIDESUN PHARMANDA 215837ABOct 19, 2023
PAZOPANIB HYDROCHLORIDETEVA PHARMS INCANDA 217517ABOct 19, 2023

Marketing exclusivity (1)

  • CGTFDA marketing exclusivity

    May 06, 2026

    1 mo ago

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Pazopanib 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.