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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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-1810 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	Open	Pharmobedient Consulting

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ambisome (2023)

Total Spending

$1.4M

Total Claims

463

Beneficiaries

144

Avg Cost/Unit

$235.79

Spending Trend

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

YoY Change:+176.1%

5yr CAGR:+22.8%

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 AmbIsome (2023)

Total Spending

$1.7M

Total Claims

1,145

Beneficiaries

195

ASP Price

—

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

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

API Supply Chain4 active DMFs6 inactive

3 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

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.