Drug

Ranibizumab

As of the edition of 20 October 2026, Ranibizumab is an antibody: marketed, first approved in 2006 (US); acts on VEGFA; US protection ended in 2018.

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

The drug

Status
Marketed; latest approval 2026
Kind
Antibody
Brand name
Lucentis
First approved
30 June 2006 (US)
Approvals on record
16 in 5 regions
Holder of the most recent approval
Roche; 6 holders in all
Registered trials
384, 44 stopped early
Disease areas
Eye; Heart and blood vessels; Hormones; Nervous system; Inherited and neonatal; Nutrition and metabolism

US protection

US protection ended in 2018.

US protection ended in 2018, 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 Roche. 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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Target

GeneProteinUniProt
VEGFAVascular endothelial growth factor A, long formP15692

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated654324
Phase 1423306
Phase 210785113
Phase 39060612
Phase 4805119
All trials384

Who has held its approvals

CompanyRoleYears
RocheApplicant, Later holder and Lead sponsor of trials2002 to now
NovartisApplicant and Lead sponsor of trials2004 to now