Viewing data from:

SUNITINIB MALATE

ANDA

SUNITINIB MALATE | A201275 | MYLAN PHARMACEUTICALS INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SUTENT(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Mylan Inc. et al 1:2010cv00528 3 patentsANDA 201275Sunitinib Malate	D. Del.	2010-06-16	Terminated 2014-10-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Medicare Part D Spending

CMS annual spending data for Sunitinib Malate (2023)

Total Spending

$60.7M

Total Claims

7,212

Beneficiaries

1,343

Avg Cost/Unit

$354.85

Spending Trend

$15.6M(2021)→$55.6M(2022)→$60.7M(2023)

YoY Change:-10.0%

5yr CAGR:-9.5%

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

API Supply Chain8 active DMFs2 inactive

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

TAPI NL BVSUNITINIB MALATE

DMF 234142009

RELIANCE LIFE SCIENCES PVT LTDSUNITINIB MALATE

DMF 290142015

SHILPA MEDICARE LTDSUNITINIB

DMF 296532021

MEDICHEM MANUFACTURING (MALTA) LTDSUNITINIB MALATE

DMF 305592016

SHILPA PHARMA LIFESCIENCES LTDSUNITINIB MALATE

DMF 330852018

MSN LABORATORIES PRIVATE LTDSUNITINIB MALATE

DMF 333082018

HETERO LABS LTDSUNITINIB MALATE

DMF 362012021

CDYMAX (INDIA) PHARMA PRIVATE LTDSUNITINIB MALATE

DMF 363922021

MYLAN LABORATORIES LTDInactiveSUNITINIB MALATE

DMF 245092010

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveSUNITINIB MALATE

DMF 264642012

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

Products (4)

Sort:

#001 — EQ 12.5MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 6, 2021

No patent or exclusivity listings for this strength.

#002 — EQ 25MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 6, 2021

#003 — EQ 37.5MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 6, 2021

#004 — EQ 50MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 6, 2021