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BLA

TALIGLUCERASE ALFA | B022458 | PFIZER

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

May 1, 2024(793 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 1, 2024	Expired	Computed

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 22458

351(a) ReferenceLicensedCDERFor Injection

Proper Name

taliglucerase alfa

Applicant

Pfizer Inc.

Approval Date

1-May-12

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

Approval Letters

14 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 200 UNITS/VIAL

▴

POWDER;INTRAVENOUS | Approved: 2012-05-01 00:00:00

No patent or exclusivity listings for this strength.