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NOXAFIL

NDA

POSACONAZOLE | N022003 | SCHERING CORP

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
MERCK SHARP & DOHME CORP. v. SANDOZ INC. 3:2020cv00783 1 patentANDA 202481posaconazole	D.N.J.	2020-01-23	Terminated 2020-08-26	—

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

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Withdrawal of Suitability Petition from Reyoung Pharmaceutical Co., Ltd. FDA-2022-P-1833 · 5 docket documents Reyoung Pharmaceutical Co., Ltd. filed this letter on November 21, 2023, to withdraw its suitability petition (FDA-2022-P-1833) requesting FDA declaration that posaconazole delayed-release oral suspension, USP, 100 mg, is suitable for consideration in an Abbreviated New Drug Application.	Suitability	2023-11-21	Withdrawn	Reyoung Pharmaceutical Co., Ltd.
Attachment 2 - Draft Package Insert Proposed for posaconazole for delayed-rel... FDA-2023-P-1227 · 5 docket documents Reyoung Pharmaceutical Co., Ltd. filed a Suitability Petition regarding posaconazole for delayed-release oral suspension, USP, 100 mg, and submitted a draft package insert for the product as part of the petition.	Suitability	2023-03-31	Withdrawn	Reyoung Pharmaceutical Co., Ltd.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

58 trials from ClinicalTrials.gov — 3 recruiting, 44 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Azoles Targeting Recurrent High Grade Gliomas NCT03763396	Early Phase 1	Not Yet Recruiting	University Health Network, Toronto	30	2024-06-01 → 2027-06
PTX3-targeted Antifungal Prophylaxis NCT03828773	N/A	Recruiting	Bochud Pierre-Yves	410	2019-02-11 → 2027-11-30
Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants NCT03717623	Phase 4	Recruiting	Melbourne Health	100	2019-08-01 → 2025-12-30
Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)NCT00686621	—	APPROVED_FOR_MARKETING	Merck Sharp & Dohme LLC	—	—
A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid Tumors NCT01901172	Phase 1	Completed	Hoffmann-La Roche	61	2013-08 → 2015-06
Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease NCT04294641	Phase 2	Completed	National Cancer Institute (NCI)	10	2021-05-10 → 2024-10-01
Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)NCT00034658	Phase 3	Completed	Merck Sharp & Dohme LLC	336	1998-12 → 2002-03
A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)NCT00550732	Phase 2	Completed	Merck Sharp & Dohme LLC	40	2007-12 → 2012-11
Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120)NCT03336502	Phase 1	Completed	Merck Sharp & Dohme LLC	70	2017-12-20 → 2018-11-26
Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520)NCT01075984	Phase 1	Completed	Merck Sharp & Dohme LLC	279	2010-02-23 → 2012-11-20

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$538.85

Highest Price

$1417.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00254-1016-36POSACONAZOLE 200MG/5ML SUSP,ORAL	$651.39	FSS	Endo USA, Inc.	09/30/2026
00254-1016-36POSACONAZOLE 200MG/5ML SUSP,ORAL	$538.85	Big4	Endo USA, Inc.	09/30/2026
00085-1328-01NOXAFIL 200MG/5ML ORAL SUSP	$1417.85	FSS	Merck Sharp & Dohme LLC	05/31/2030
00085-1328-01NOXAFIL 200MG/5ML ORAL SUSP	$1075.89	Big4	Merck Sharp & Dohme LLC	05/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Noxafil (2024)

Total Spending

$632K

Total Claims

146

Beneficiaries

Avg Cost/Unit

$58.66

Spending Trend

$78.6M(2019)→$15.5M(2020)→$8.0M(2021)→$5.4M(2022)→$2.5M(2023)→$632K(2024)

YoY Change:+64.6%

5yr CAGR:+6.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain29 active DMFs1 inactive

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

OLON SPAPOSACONAZOLE

DMF 243462010

MSN LABORATORIES PRIVATE LTDPOSACONAZOLE AMORPHOUS [ROUTE CODE PKA]

DMF 276142013

MSN LABORATORIES PRIVATE LTDPOSACONAZOLE (FORM-I) [ROUTE CODE - "PJ1"]

DMF 277202013

ALP PHARM BEIJING CO LTDPOSACONAZOLE FOMR I

DMF 282232017

WUHAN ZY PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 283862014

NEULAND LABORATORIES LTDPOSACONAZOLE

DMF 288262018

WUHAN ZY PHARMACEUTICAL CO LTDPOSACONAZOLE FORM 1

DMF 292282015

MSN LABORATORIES PRIVATE LTDPOSACONAZOLE AMORPHOUS (PROCESS-2) [ROUTE CODE - "PKA"]

DMF 293492015

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 297312016

APOTEX INCPOSACONAZOLE

DMF 303432016

JIANGSU HANSYN PHARMACEUTICAL CO LTDPOSACONAZOLE FORM I

DMF 308592016

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPOSACONAZOLE CRYSTALLINE III

DMF 308862016

SOLARA ACTIVE PHARMA SCIENCES LTDPOSACONAZOLE FORM-1

DMF 315772017

DR REDDYS LABORATORIES LTDPOSACONAZOLE

DMF 320982017

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPOSACONAZOLE CRYSTALLINE I (NON-STERILE, API)

DMF 323462017

BIOCON LTDPOSACONAZOLE

DMF 325242018

HONOUR LAB LTDPOSACONAZOLE (FORM-I)

DMF 329732018

COHANCE LIFESCIENCES LTDPOSACONAZOLE

DMF 344512019

QUIMICA SINTETICA SAPOSACONAZOLE

DMF 354402020

METROCHEM API PRIVATE LTDPOSACONAZOLE

DMF 355172021

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDPOSACONAZOLE FORM I

DMF 361162021

BIOCON LTDPOSACONAZOLE

DMF 366882022

METROCHEM API PRIVATE LTDPOSACONAZOLE (FORM I)

DMF 369692022

SHANDONG JINCHENG KUNLUN PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 377342022

CHROMO LABORATORIES INDIA PRIVATE LTDPOSACONAZOLE

DMF 407312025

WEINAN MANARECO PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 407682024

CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 409592024

SICHUAN KELUN PHARMACEUTICAL CO LTDPOSACONAZOLE

DMF 417682025

BIOCON LTDPOSACONAZOLE (FORM-1)

DMF 424092025

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDInactivePOSACONAZOLE (NON STERILE API)

DMF 283142014

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

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
Jan 27, 2026	SUPPL -34	View Letter (PDF)
Oct 29, 2024	SUPPL -33	View Letter (PDF)
Jan 21, 2022	SUPPL -27	View Letter (PDF)
Jan 18, 2022	SUPPL -28	View Letter (PDF)
Jan 4, 2022	SUPPL -30	View Letter (PDF)
Sep 17, 2020	SUPPL -26	View Letter (PDF)
Mar 12, 2019	SUPPL -24	View Letter (PDF)
Feb 22, 2019	SUPPL -25	View Letter (PDF)
Jan 8, 2018	SUPPL -22	View Letter (PDF)
Sep 15, 2016	SUPPL -21	View Letter (PDF)
Nov 18, 2015	SUPPL -20	View Letter (PDF)
Nov 18, 2015	SUPPL -18	View Letter (PDF)
Jul 16, 2015	SUPPL -16	View Letter (PDF)
Jun 25, 2012	SUPPL -12	View Letter (PDF)
Jun 25, 2012	SUPPL -11	View Letter (PDF)
Sep 13, 2010	SUPPL -8	View Letter (PDF)
Feb 23, 2009	SUPPL -7	View Letter (PDF)
May 21, 2008	SUPPL -6	View Letter (PDF)
May 21, 2008	SUPPL -2	View Letter (PDF)
Sep 20, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML

RLDAB

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Sep 15, 2006

No patent or exclusivity listings for this strength.