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BLA

VESTRONIDASE ALFA-VJBK | B761047 | ULTRAGENYX PHARM INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

November 15, 2029(1231 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 15, 2029	Active	Computed
7-Year Orphan	Nov. 15, 2024	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 761047

351(a) ReferenceLicensedCDERInjection

Proper Name

vestronidase alfa-vjbk

Applicant

Ultragenyx Pharamceutical Inc.

Approval Date

15-Nov-17

Orphan Exclusivity

15-Nov-24

Expired

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/5ML

▴

INJECTABLE;INJECTION | Approved: 2017-11-15 00:00:00

No patent or exclusivity listings for this strength.