Drug

Eltrombopag

As of the edition of 20 October 2026, Eltrombopag is a small molecule: marketed, first approved in 2008 (US); acts on MPL; US protection ended in 2025.

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

The drug

Status
Marketed; latest approval 2011
Kind
Small molecule
Brand name
Promacta
First approved
20 November 2008 (US)
Approvals on record
18 in 4 regions
Holder of the most recent approval
Teva; 4 holders in all
Registered trials
155, 19 stopped early
Disease areas
Blood and lymph; Immune system; Cancer; Digestive system; Infections; Inherited and neonatal

US protection

US protection ended in 2025.

The last listed US drug-substance patent ended in 2025.

Teva holds a later exclusivity on its own new formulation or combination product, ending 2038; it does not protect the original drug.

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

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

See the exact date and the 29 listings behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Eltrombopag.

Target

GeneProteinUniProt
MPLThrombopoietin receptorP40238

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated211161
Phase 1181303
Phase 280431612
Phase 3271832
Phase 49331
All trials155

Who has held its approvals

CompanyRoleYears
GSKOriginator and Lead sponsor of trials2005 to now
NovartisApplicant, Acquired holder and Lead sponsor of trials2010 to now
TevaLater holder2023 to now