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AMBISOME

NDA

AMPHOTERICIN B | N050740 | ASTELLAS PHARMA US INC

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-1810 · 8 docket documents Pharmobedient Consulting, LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Amphotericin B Liposome for Injection in a 100 mg/vial strength is suitable for submission in an ANDA, based on the listed drug	Suitability	2024-04-11	Granted	Pharmobedient Consulting, LLC
Citizen Petition from Lachman Consultant Services, Inc. FDA-2016-P-1287 · 7 docket documents Lachman Consultant Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine Amphotericin B Liposome for Injection, 250 mg/vial lyophilized powder is suitable for submission in an ANDA, referencing the list	Other	2016-05-19	Granted	Lachman Consultant Services, Inc.

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

Clinical Trials

94 trials from ClinicalTrials.gov, 66 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome NCT00002019	N/A	Completed	Liposome	—	—
Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).NCT02273661	Phase 2	Completed	Poitiers University Hospital	174	2014-11-19 → 2019-06-28
To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early NCT00361517	Phase 3	Completed	Singapore General Hospital	47	2006-06-01 → 2009-06-30
CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis NCT02629419	Phase 2	Completed	Matinas BioPharma Nanotechnologies, Inc.	4	2016-09-27 → 2022-08-06
MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis (0991-037)NCT00076869	Phase 2	Completed	Merck Sharp & Dohme LLC	55	2003-01 → 2005-08
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)NCT02971007	Phase 2	Completed	Matinas BioPharma Nanotechnologies, Inc.	137	2016-11 → 2017-05
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT)NCT04031833	Phase 1/2	Completed	Matinas BioPharma Nanotechnologies, Inc.	178	2019-10-24 → 2023-02-15
Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study NCT00177710	Phase 3	Completed	University of Pittsburgh	48	2006-01 → 2007-12
A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar NCT00497601	Phase 2	Completed	Banaras Hindu University	60	2007-02 → 2008-07
Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment NCT00008359	Phase 3	Completed	Memorial Sloan Kettering Cancer Center	—	2000-08

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

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$73.13

Highest Price

$73.13

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00469-3051-30AMBISOME 50MG INJECTION	$73.13	FSS	Astellas Pharma U.S., Inc.	09/29/2026

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

Medicare Part D Spending

CMS annual spending data for Ambisome (2024)

Total Spending

$939K

Total Claims

325

Beneficiaries

Avg Cost/Unit

$199.14

Spending Trend

$1.4M(2019)→$1.7M(2020)→$2.0M(2021)→$2.0M(2022)→$1.4M(2023)→$939K(2024)

YoY Change:-15.5%

5yr CAGR:+27.1%

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

Medicare Part B Spending

CMS physician-administered drug spending for AmbIsome (2024)

Total Spending

$1.8M

Total Claims

1,088

Beneficiaries

205

ASP Price

$24.82

Spending Trend

$2.7M(2019)→$2.6M(2020)→$2.3M(2021)→$2.3M(2022)→$1.7M(2023)→$1.8M(2024)

YoY Change:-5.2%

5yr CAGR:-0.0%

HCPCS: J0289 — Injection, amphotericin b liposome, 10 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain5 active DMFs6 inactive

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

XELLIA PHARMACEUTICALS APSAMPHOTERICIN B

DMF 136821998

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDAMPHOTERICIN B USP NON-STERILE BULK DRUG

DMF 181572005

ASENCE PHARMA PRIVATE LTDAMPHOTERICIN B USP [ORAL GRADE]

DMF 261842012

ASENCE PHARMA PRIVATE LTDAMPHOTERICIN B USP [INTENDED FOR USE IN PREPARING PARENTERAL DOSAGE FORMS]

DMF 263752012

ZHEJIANG TIANTAI PHARMACEUTICAL CO LTDAMPHOTERICIN B

DMF 435752026

SHANGHAI ASIA PIONEER CO LTDInactiveAMPHOTERICIN B

DMF 132241998

PFIZER INCInactiveAMPHOTERICIN B

DMF 135441998

CELL PRODUCTS INCInactiveAMPHOTERICIN B

DMF 136461998

CELL PRODUCTS INCInactiveAMPHOTERICIN B

DMF 136481998

BRISTOL MYERS SQUIBB COInactiveAMPHOTERICIN B

DMF 137011998

ASENCE PHARMA PRIVATE LTDInactiveAMPHOTERICIN B

DMF 138191998

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Nov 5, 2024	SUPPL -37	View Letter (PDF)
Feb 5, 2021	SUPPL -33	View Letter (PDF)
May 13, 2020	SUPPL -31	View Letter (PDF)
Mar 13, 2012	SUPPL -21	View Letter (PDF)
Oct 14, 2008	SUPPL -16	View Letter (PDF)
Sep 25, 2003	SUPPL -14	View Letter (PDF)
Jul 18, 2000	SUPPL -2	View Letter (PDF)
Jan 28, 2000	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/VIAL

RLDAB

0 patents0 exclusivities▴

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Aug 11, 1997

No patent or exclusivity listings for this strength.