Viewing data from:

VORAXAZE

BLA

GLUCARPIDASE | B125327 | BTG INTERNATIONAL INC

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

January 17, 2024(898 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jan. 17, 2024	Expired	Computed
7-Year Orphan	Jan. 17, 2019	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 125327

351(a) ReferenceLicensedCDERFor Injection

Proper Name

glucarpidase

Applicant

BTG International Inc.

Approval Date

17-Jan-12

Orphan Exclusivity

17-Jan-19

Expired

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 1000 UNITS PER VIAL

▴

INJECTABLE; INJECTION | Approved: 2012-01-17 00:00:00

No patent or exclusivity listings for this strength.