Drug

Interferon alfa-2b

As of the edition of 20 October 2026, Interferon alfa-2b is a protein: marketed, first approved in 1986 (US); acts on IFNAR1 and IFNAR2; US protection ended in 1998.

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

The drug

Status
Marketed; latest approval 1986
Kind
Protein
Brand name
Intron A
First approved
4 June 1986 (US)
Approvals on record
14 in 1 region
Holder of the most recent approval
Merck & Co.
Withdrawn from market
13 October 2008 (in some regions)
Registered trials
79, 15 stopped early
Disease areas
Cancer; Skin and connective tissue; Infections; Digestive system; Urinary and reproductive; Pregnancy and women's health

US protection

US protection ended in 1998.

US protection ended in 1998, 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 Merck & Co.. 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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Targets

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

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated8401
Phase 1211902
Phase 2301828
Phase 3181033
Phase 42101
All trials79

Who has held its approvals

CompanyRoleYears
Merck & Co.Applicant and Lead sponsor of trials1986 to now