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VOTRIENT

NDA

PAZOPANIB HYDROCHLORIDE | N022465 | NOVARTIS PHARMACEUTICALS CORP

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery NCT01575548	Phase 3	Active	National Cancer Institute (NCI)	129	2012-08-08 → 2027-02-20
Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors NCT01841736	Phase 2	Active	National Cancer Institute (NCI)	171	2013-09-20 → 2026-09-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Votrient (2023)

Total Spending

$98.0M

Total Claims

7,601

Beneficiaries

1,555

Avg Cost/Unit

$148.01

Spending Trend

$204.1M(2019)→$147.8M(2020)→$126.1M(2021)→$106.6M(2022)→$98.0M(2023)

YoY Change:+9.8%

5yr CAGR:+7.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain11 active DMFs1 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

HETERO LABS LTDPAZOPANIB HYDROCHLORIDE

DMF 262072012

MSN LABORATORIES PRIVATE LTDPAZOPANIB HYDROCHLORIDE [ROUTE CODE - "PY"]

DMF 274222013

FORMOSA LABORATORIES INCPAZOPANIB HYDROCHLORIDE

DMF 312972017

CIPLA LTDPAZOPANIB HYDROCHLORIDE

DMF 328992018

ZHEJIANG LEPU PHARMACEUTICAL CO LTDPAZOPANIB HYDROCHLORIDE

DMF 341462019

DR REDDYS LABORATORIES LTDPAZOPANIB HYDROCHLORIDE

DMF 357322021

GRANULES INDIA LTDPAZOPANIB HYDROCHLORIDE

DMF 360372021

MEDICHEM SAPAZOPANIB HYDROCHLORIDE

DMF 361922021

SUN PHARMACEUTICAL INDUSTRIES LTDPAZOPANIB HYDROCHLORIDE

DMF 365502022

LAURUS LABS LTDPAZOPANIB HYDROCHLORIDE

DMF 366892022

SYNTHIMED LABS PRIVATE LTDPAZOPANIB HYDROCHLORIDE

DMF 414812025

INTAS PHARMACEUTICALS LTDInactivePAZOPANIB HYDROCHLORIDE

DMF 346932020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

29 letters from Drugs@FDA

Date	Submission	Document
Jan 26, 2024	SUPPL -36	View Letter (PDF)
Feb 18, 2022	SUPPL -33	View Letter (PDF)
Sep 23, 2021	SUPPL -32	View Letter (PDF)
Sep 23, 2021	SUPPL -31	View Letter (PDF)
Aug 18, 2020	SUPPL -29	View Letter (PDF)
Jul 20, 2020	SUPPL -30	View Letter (PDF)
Jun 3, 2020	SUPPL -28	View Letter (PDF)
Jun 5, 2017	SUPPL -25	View Letter (PDF)
Jun 5, 2017	SUPPL -24	View Letter (PDF)
Aug 5, 2016	SUPPL -23	View Letter (PDF)
May 24, 2016	SUPPL -22	View Letter (PDF)
Sep 24, 2015	SUPPL -21	View Letter (PDF)
Apr 2, 2015	SUPPL -20	View Letter (PDF)
Nov 20, 2014	SUPPL -19	View Letter (PDF)
Jun 5, 2014	SUPPL -18	View Letter (PDF)
Dec 18, 2013	SUPPL -17	View Letter (PDF)
Aug 16, 2013	SUPPL -14	View Letter (PDF)
Aug 16, 2013	SUPPL -15	View Letter (PDF)
Aug 16, 2013	SUPPL -16	View Letter (PDF)
Nov 16, 2012	SUPPL -13	View Letter (PDF)
May 2, 2012	SUPPL -12	View Letter (PDF)
May 2, 2012	SUPPL -10	View Letter (PDF)
Mar 26, 2012	SUPPL -11	View Letter (PDF)
Jan 17, 2012	SUPPL -7	View Letter (PDF)
Oct 25, 2011	SUPPL -5	View Letter (PDF)
Oct 25, 2011	SUPPL -3	View Letter (PDF)
Apr 22, 2011	SUPPL -6	View Letter (PDF)
May 3, 2010	SUPPL -2	View Letter (PDF)
Nov 3, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 200MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 19, 2009

No patent or exclusivity listings for this strength.

#002 — EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 19, 2009