Viewing data from:

RUBRACA

NDA

RUCAPARIB CAMSYLATE | N209115 | PHARMAAND GMBH

3 strengths9 unique patents1 unique exclusivity

Patent Timeline

9 unique patents, 1 exclusivity by expiration date

Active (9)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Aug. 12, 2027

Aug. 12, 2027

Feb. 10, 2031

Aug. 4, 2031

Feb. 10, 2031

Feb. 10, 2031

Aug. 17, 2035

Aug. 17, 2035

Feb. 10, 2031

I-982

Dec. 17, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Rubraca (2023)

Total Spending

$43.0M

Total Claims

3,079

Beneficiaries

556

Avg Cost/Unit

$149.21

Spending Trend

$60.2M(2019)→$70.7M(2020)→$64.4M(2021)→$49.0M(2022)→$43.0M(2023)

YoY Change:+1.2%

5yr CAGR:+2.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

FORMOSA LABORATORIES INCRUCAPARIB CAMSYLATE

DMF 344192019

MSN LABORATORIES PRIVATE LTDRUCAPARIB CAMSYLATE

DMF 355852021

BIOPHORE INDIA PHARMACEUTICALS PVT LTDRUCAPARIB CAMSYLATE

DMF 423482025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Dec 19, 2025	SUPPL -15	View Letter (PDF)
Dec 19, 2025	SUPPL -14	View Letter (PDF)
Dec 22, 2022	SUPPL -13	View Letter (PDF)
Jun 13, 2022	SUPPL -11	View Letter (PDF)
Oct 4, 2021	SUPPL -9	View Letter (PDF)
Oct 9, 2020	SUPPL -8	View Letter (PDF)
May 19, 2020	SUPPL -4	View Letter (PDF)
Apr 12, 2018	SUPPL -3	View Letter (PDF)
Dec 21, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 200MG BASE

RLD

9 patents1 exclusivity▴

TABLET;ORAL | Approved: Dec 19, 2016

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8071579	Aug 12, 2027	—	—	—		—
8143241	Aug 12, 2027	—	—	—		—
8754072	Feb 10, 2031	—	Yes	Yes	—	—
8859562	Aug 4, 2031	—	—	—		—
9045487	Feb 10, 2031	—	Yes	Yes	—	—
9861638	Feb 10, 2031	—	—	—		—
9987285	Aug 17, 2035	—	—	Yes	—	—
10130636	Aug 17, 2035	—	—	—		—
10278974	Feb 10, 2031	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
I-982	Dec 17, 2028	Active

#002 — EQ 300MG BASE

RLD

9 patents1 exclusivity▾

TABLET;ORAL | Approved: Dec 19, 2016

#003 — EQ 250MG BASE

RLD

9 patents1 exclusivity▾

TABLET;ORAL | Approved: May 1, 2017