Viewing data from:

CEREZYME

BLA

IMIGLUCERASE | B020367 | GENZYME

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Cerezyme (2024)

Total Spending

$44.2M

Total Claims

2,260

Beneficiaries

140

ASP Price

$43.83

Spending Trend

$35.8M(2020)→$39.0M(2021)→$43.7M(2022)→$46.0M(2023)→$44.2M(2024)

YoY Change:-1.2%

5yr CAGR:+3.1%

HCPCS: J1786 — Injection, imiglucerase, 10 units

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

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200 UNITS/VIAL

▴

INJECTABLE;INJECTION | Approved: 1994-05-23 00:00:00

No patent or exclusivity listings for this strength.

#002 — 400 UNITS/VIAL

▾

INJECTABLE;INJECTION | Approved: 1994-05-23 00:00:00