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CRESEMBA

NDA

ISAVUCONAZONIUM SULFATE | N207501 | ASTELLAS PHARMA US INC

1 strength1 unique patent9 unique exclusivities

Patent Timeline

1 unique patent, 6 exclusivities by expiration date

Expired (1)TodayPED (+6 mo)Exclusivity

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

Today

6812238

Apr. 30, 2026

ODE-305

Sep. 6, 2022

ODE-90

Sep. 6, 2022

NPP

Jun. 8, 2027

GAIN

Mar. 6, 2028

ODE-453

Jun. 8, 2031

ODE-459

Jun. 8, 2031

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
Astellas Pharma Inc. et al v. Cipla Limited et al 1:2024cv01287 1 patentANDA 219496, 219877isavuconazonium sulfate	D. Del.	2024-11-22	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

6 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects NCT01813461	Phase 1	Completed	Astellas Pharma Global Development, Inc.	8	2012-10 → 2012-11
Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)NCT03149055	Phase 2	Completed	Memorial Sloan Kettering Cancer Center	99	2017-05-04 → 2021-11-08
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients NCT03241550	Phase 1	Completed	Astellas Pharma Global Development, Inc.	49	2017-10-02 → 2019-07-05
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants NCT03816176	Phase 2	Completed	Astellas Pharma Global Development, Inc.	31	2019-08-22 → 2022-12-14
A Study to Evaluate the Pharmacokinetics of BAL8728 After a Single Dose of Pyridinylmethyl-14C-Labeled Isavuconazonium Sulfate in Healthy Male Subjects NCT02059590	Phase 1	Completed	Astellas Pharma Global Development, Inc.	6	2013-04 → 2013-04
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants NCT04096157	Phase 1	Completed	Astellas Pharma Global Development, Inc.	17	2019-09-24 → 2020-01-16

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

VA Federal Supply Schedule

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

Lowest Price

$244.96

Highest Price

$244.96

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00469-0420-01CRESEMBA 372MG VIAL	$244.96	FSS	Astellas Pharma U.S., Inc.	09/29/2026

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

API Supply Chain15 active DMFs

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

METROCHEM API PRIVATE LTDISAVUCONAZONIUM SULFATE

DMF 369742022

ALIVUS LIFE SCIENCES LTDISAVUCONAZONIUM SULFATE

DMF 382512023

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDISAVUCONAZONIUM SULFATE

DMF 385022023

BIOPHORE INDIA PHARMACEUTICALS PVT LTDISAVUCONAZONIUM SULFATE

DMF 387812023

HONOUR LAB LTDISAVUCONAZONIUM SULFATE

DMF 387842023

ZAKLADY FARMACEUTYCZNE POLPHARMA SAISAVUCONAZONIUM SULFATE

DMF 389642023

PORTON PHARMA SOLUTIONS LTDISAVUCONAZONIUM SULFATE API, NON-STERILE DRUG SUBSTANCE

DMF 390122023

CIPLA LTDISAVUCONAZONIUM SULFATE

DMF 391512023

SICHUAN D-INNOVATION PHARMACEUTICAL CO LTDISAVUCONAZONIUM SULFATE

DMF 391932023

MSN LIFE SCIENCES PRIVATE LTDISAVUCONAZONIUM SULFATE

DMF 394962024

OPTIMUS DRUGS PRIVATE LTDISAVUCONAZONIUM SULFATE

DMF 397772024

METROCHEM API PRIVATE LTDISAVUCONAZONIUM SULFATE (KYO)

DMF 398232024

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDISAVUCONAZONIUM SULFATE

DMF 403242024

BEIJING HOPE PHARMACEUTICAL CO LTDISAVUCONAZONIUM SULFATE

DMF 407732024

GLAND PHARMA LTDISAVUCONAZONIUM SULFATE

DMF 418872025

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Mar 25, 2025	SUPPL -16	View Letter (PDF)
Dec 11, 2023	SUPPL -13	View Letter (PDF)
May 4, 2022	SUPPL -9	View Letter (PDF)
Dec 14, 2021	SUPPL -8	View Letter (PDF)
May 19, 2021	SUPPL -5	View Letter (PDF)
Apr 26, 2021	SUPPL -7	View Letter (PDF)
Dec 11, 2019	SUPPL -4	View Letter (PDF)
Apr 6, 2015	SUPPL -1	View Letter (PDF)
Mar 6, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 372MG

RLD

1 patent9 exclusivities▴

POWDER;INTRAVENOUS | Approved: Mar 6, 2015

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
6812238	Oct 31, 2025PED: Apr 30, 2026	PED	Yes	—	—	—

Exclusivities (9)

Code	Date	Status
GAIN	Sep 6, 2027	Active
NPP	Dec 8, 2026	< 1 year
ODE-305	Mar 6, 2022	Expired
ODE-453	Dec 8, 2030	Active
ODE-459	Dec 8, 2030	Active
ODE-90	Mar 6, 2022	Expired
PED	Jun 8, 2027	< 1 year
PED	Jun 8, 2031	Active
PED	Sep 6, 2022	Expired