Drug

Rucaparib

As of the edition of 20 October 2026, Rucaparib is a small molecule: marketed, first approved in 2016 (US); acts on PARP1, PARP2 and PARP3; US protection ends in 2031.

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

The drug

Status
Marketed; latest approval 2018
Kind
Small molecule
Brand name
Rubraca
First approved
19 December 2016 (US)
Approvals on record
4 in 2 regions
Holder of the most recent approval
pharmaand
Registered trials
63, 14 stopped early
Disease areas
Cancer; Urinary and reproductive; Pregnancy and women's health; Hormones; Skin and connective tissue; Digestive system

US protection

US protection ends in 2031.

The last listed US drug-substance patent ends in 2031. The application that gives this date is held by pharmaand.

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

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

See the exact date and the 9 listings behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

5 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

5 company-target rows are on route B because of Rucaparib.

Targets

GeneProteinUniProt
PARP1Poly [ADP-ribose] polymerase 1P09874
PARP2Poly [ADP-ribose] polymerase 2Q9UGN5
PARP3Protein mono-ADP-ribosyltransferase PARP3Q9Y6F1

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated3300
Phase 1131300
Phase 23916614
Phase 38530
All trials63

Who has held its approvals

CompanyRoleYears
pharmaandAcquired holder and Lead sponsor of trials2010 to now
Clovis OncologyOriginator2016 to 2024