Drug

Asparaginase erwinia chrysanthemi

As of the edition of 20 October 2026, Asparaginase erwinia chrysanthemi is an enzyme: marketed, first approved in 2011 (US); US protection ended in 2023.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2011
Kind
Enzyme
Brand name
Erwinaze
First approved
18 November 2011 (US)
Approvals on record
2 in 1 region
Holder of the most recent approval
Jazz Pharmaceuticals; 2 holders in all
Registered trials
15, 1 stopped early
Disease areas
Blood and lymph; Cancer; Immune system; Infections; Inherited and neonatal; Nervous system

US protection

US protection ended in 2023.

US protection ended in 2023, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Jazz Pharmaceuticals. The date is computed, not published.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 11010
Phase 210271
Phase 34040
All trials15

Who has held its approvals

CompanyRoleYears
Jazz PharmaceuticalsApplicant, Later holder and Lead sponsor of trials2011 to now