Viewing data from:

PURIXAN

NDA

MERCAPTOPURINE | N205919 | NOVA LABORATORIES LTD

1 strength0 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Purixan (2023)

Total Spending

$59K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$15.28

Spending Trend

$35K(2019)→$61K(2020)→$125K(2021)→$116K(2022)→$59K(2023)

YoY Change:+5.2%

5yr CAGR:+4.6%

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

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

AARTI PHARMALABS LTDMERCAPTOPURINE

DMF 229712009

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDMERCAPTOPURINE

DMF 268492012

CHANGZHOU SIYAO PHARMACEUTICALS CO LTDInactiveMERCAPTOPURINE USP

DMF 165752003

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDInactiveMERCAPTOPURINE USP

DMF 168052003

BENZOCHEM LIFESCIENCES PVT LTDInactiveMERCAPTOPURINE USP

DMF 212672008

RPG LIFE SCIENCES LTDInactiveMERCAPTOPURINE USP

DMF 217582008

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Oct 24, 2024	SUPPL -7	View Letter (PDF)
Jul 10, 2024	SUPPL -8	View Letter (PDF)
Apr 8, 2020	SUPPL -4	View Letter (PDF)
Feb 26, 2018	SUPPL -3	View Letter (PDF)
May 10, 2017	SUPPL -2	View Letter (PDF)
Dec 31, 2014	SUPPL -1	View Letter (PDF)
Apr 29, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/ML

RLDAB

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Apr 28, 2014

No patent or exclusivity listings for this strength.