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CEREZYME

BLA

IMIGLUCERASE | B020367 | GENZYME

2 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

May 23, 2001(9172 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	May. 23, 2001	Expired	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

Purple Book (Biologics)

BLA 20367 | 2 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

imiglucerase

Applicant

Genzyme Corporation

Approval Date

23-May-94

Orphan Exclusivity

23-May-01

Expired

Presentations

200UNITS/VIAL — Single-Dose Vial (Intravenous)

400UNITS/VIAL — Single-Dose Vial (Intravenous)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jan 13, 2026	SUPPL -123	View Letter (PDF)
Dec 20, 2024	SUPPL -122	View Letter (PDF)
Jul 11, 2024	SUPPL -121	View Letter (PDF)
Dec 27, 2021	SUPPL -119	View Letter (PDF)
Apr 20, 2020	SUPPL -66	View Letter (PDF)
Mar 23, 2020	SUPPL -53	View Letter (PDF)
Mar 23, 2020	SUPPL -55	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200 UNITS/VIAL

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

No patent or exclusivity listings for this strength.

#002 — 400 UNITS/VIAL

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