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GLEOSTINE

NDA

LOMUSTINE | N017588 | AZURITY PHARMACEUTICALS INC

4 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Gleostine (2023)

Total Spending

$2.7M

Total Claims

2,208

Beneficiaries

662

Avg Cost/Unit

$692.50

Spending Trend

$2.7M(2019)→$2.5M(2020)→$24K(2021)→$2.7M(2023)

5yr CAGR:+4.2%

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

API Supply Chain2 active DMFs

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

STARKS ASSOC INCLOMUSTINE (CCNU) BULK

DMF 24201975

DR REDDYS LABORATORIES LTDLOMUSTINE USP

DMF 284052014

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jun 17, 2020	SUPPL -46	View Letter (PDF)
Feb 1, 2016	SUPPL -43	View Letter (PDF)
Jan 7, 2016	SUPPL -42	View Letter (PDF)
May 22, 2014	SUPPL -40	View Letter (PDF)
Nov 23, 2012	SUPPL -36	View Letter (PDF)
May 16, 2011	SUPPL -37	View Letter (PDF)
May 6, 2009	SUPPL -34	View Letter (PDF)
Mar 10, 2003	SUPPL -33	View Letter (PDF)
Dec 20, 2002	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 10MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 40MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 100MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 5MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 19, 2014