Drug

Peginterferon alfa-2a

As of the edition of 20 October 2026, Peginterferon alfa-2a is a protein: marketed, first approved in 2002 (EU); acts on IFNAR1 and IFNAR2; US protection ended in 2014.

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

The drug

Status
Marketed; latest approval 2002
Kind
Protein
Brand name
Pegasys
First approved
20 June 2002 (EU)
Approvals on record
9 in 3 regions
Holder of the most recent approval
pharmaand; 3 holders in all
Registered trials
414, 43 stopped early
Disease areas
Digestive system; Infections; Urinary and reproductive; Immune system; Cancer; Blood and lymph

US protection

US protection ended in 2014.

US protection ended in 2014, 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 pharmaand. 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

1 listing counts towards this date. The exact date and each listing are in the product.

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Targets

GeneProteinUniProt
IFNAR1Interferon alpha/beta receptor 1P17181
IFNAR2Interferon alpha/beta receptor 2P48551

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated493404
Phase 1201514
Phase 2131111215
Phase 39977115
Phase 41158105
All trials414

Who has held its approvals

CompanyRoleYears
RocheApplicant and Lead sponsor of trials2001 to now
pharmaandApplicant2002 to now