Viewing data from:

AZASAN

ANDA

AZATHIOPRINE | A075252 | AAIPHARMA LLC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: IMURAN(TE code: AB)

Medicare Part D Spending

CMS annual spending data for Azasan (2023)

Total Spending

$105K

Total Claims

117

Beneficiaries

Avg Cost/Unit

$13.08

Spending Trend

$1.6M(2019)→$1.9M(2020)→$1.5M(2021)→$310K(2022)→$105K(2023)

YoY Change:-9.5%

5yr CAGR:+2.9%

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

Medicare Part B Spending

CMS physician-administered drug spending for Azasan (2023)

Total Spending

$5.7M

Total Claims

33,386

Beneficiaries

4,183

ASP Price

—

HCPCS: J7500 — Azathioprine, oral, 50 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain12 active DMFs7 inactive

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

FERMION OYAZATHIOPRINE

DMF 54081984

FINE CHEMICALS CORP PTY LTDAZATHIOPRINE

DMF 101191993

RESOLUTION CHEMICALS LTDAZATHIOPRINE USP

DMF 175982004

AARTI PHARMALABS LTDAZATHIOPRINE USP

DMF 230382009

RAKS PHARMA PVT LTDAZATHIOPRINE USP

DMF 231792009

MATRIX PHARMACORP PRIVATE LTDAZATHIOPRINE USP

DMF 237372010

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDAZATHIOPRINE

DMF 268472012

ZYDUS LIFESCIENCES LTDAZATHIOPRINE USP

DMF 323772017

RPG LIFE SCIENCES LTDAZATHIOPRINE USP

DMF 330562018

FINE CHEMICALS CORP PTY LTDAZATHIOPRINE (PROCESS 3)

DMF 346472020

RAKS PHARMA PVT LTDAZATHIOPRINE USP (CODE AZ)

DMF 372072022

APICHEM LABORATORIES PRIVATE LTDAZATHIOPRINE USP

DMF 405382024

RESOLUTION CHEMICALS LTDInactiveAZATHIOPRINE

DMF 75751988

FERMION OYInactiveAZATHIOPRINE

DMF 125891997

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDInactiveAZATHIOPRINE USP

DMF 168062003

PROMETHEUS LABORATORIES INCInactiveAZATHIOPRINE 50 MG TABLETS AND PLACEBO TABLETS

DMF 187392005

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDInactiveAZATHIOPRINE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 196692006

RPG LIFE SCIENCES LTDInactiveAZATHIOPRINE USP

DMF 216742008

EXCELLA GMBH AND CO KGInactiveAZATHIOPRINE

DMF 233292009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 7, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 7, 1999

No patent or exclusivity listings for this strength.

#002 — 25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 3, 2003

#003 — 75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 3, 2003

#004 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 3, 2003