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BLA

ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN | B761179 | JAZZ PHARMS

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

June 30, 2033(2554 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 30, 2033	Active	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 761179

351(a) ReferenceLicensedCDERInjection

Proper Name

asparaginase erwinia chrysanthemi (recombinant)-rywn

Applicant

Jazz Pharmaceuticals Ireland Limited

Approval Date

30-Jun-21

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/0.5ML

▴

INJECTABLE;INTRAMUSCULAR | Approved: 2021-06-30 00:00:00

No patent or exclusivity listings for this strength.