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OPTISON

NDA

ALBUMIN HUMAN | N020899 | GE HEALTHCARE

1 strength0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

2028

Today

NPP

May. 9, 2028

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

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
High Dose Albumin in Refractory Ascites NCT05867602	Phase 2	Recruiting	Baylor College of Medicine	100	2019-03-25 → 2027-06-25
Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients NCT06740149	Phase 1/2	Completed	Sun Yat-sen University	90	2023-03-01 → 2026-05-31

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

Medicare Part D Spending

CMS annual spending data for Flexbumin (2023)

Total Spending

$45K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$1.21

Spending Trend

$28K(2019)→$17K(2019)→$10K(2019)→$16K(2020)→$15K(2020)→$24K(2020)→$16K(2021)→$4K(2021)→$34K(2022)→$5K(2022)→$3K(2022)→$8K(2023)→$13K(2023)→$3K(2023)→$45K(2023)→$11K(2023)

YoY Change:+0.1%

5yr CAGR:+1.6%

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 Albuked-25 (P9047) (2023)

Total Spending

$15.3M

Total Claims

79,005

Beneficiaries

16,047

ASP Price

—

Spending Trend

$1.6M(2023)→$10.1M(2023)→$736K(2023)→$15.3M(2023)

HCPCS: P9047 — Infusion, albumin (human), 25%, 50 ml

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
May 15, 2025	SUPPL -25	View Letter (PDF)
Sep 20, 2021	SUPPL -24	View Letter (PDF)
Sep 3, 2021	SUPPL -23	View Letter (PDF)
Sep 20, 2016	SUPPL -18	View Letter (PDF)
Sep 20, 2016	SUPPL -19	View Letter (PDF)
Aug 20, 2012	SUPPL -15	View Letter (PDF)
Jun 9, 2008	SUPPL -11	View Letter (PDF)
Nov 19, 2007	SUPPL -10	View Letter (PDF)
May 10, 2002	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

RLD

0 patents1 exclusivity▴

INJECTABLE;INJECTION | Approved: Dec 31, 1997

Exclusivities (1)

Code	Date	Status
NPP	May 9, 2028	Active