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

Expiring < 1yr (2)Active (7)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

3 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor NCT03521037	Phase 1	Completed	pharmaand GmbH	16	2018-02-27 → 2021-02-24
Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer NCT03552471	Phase 1	Completed	Ohio State University Comprehensive Cancer Center	25	2018-07-12 → 2022-12-19
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes NCT04171700	Phase 2	Terminated	pharmaand GmbH	83	2020-01-16 → 2022-07-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$5864.69

Highest Price

$6383.88

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82154-0783-01RUBRACA 200MG TAB	$5951.21	Big4	Summit SD LLC	03/14/2028
82154-0783-01RUBRACA 200MG TAB	$6204.05	FSS	Summit SD LLC	03/14/2028
82154-0784-01RUBRACA 250MG TAB	$6295.61	Big4	Summit SD LLC	03/14/2028
82154-0784-01RUBRACA 250MG TAB	$6383.88	FSS	Summit SD LLC	03/14/2028
82154-0785-01RUBRACA 300MG TAB	$5864.69	Big4	Summit SD LLC	03/14/2028
82154-0785-01RUBRACA 300MG TAB	$6293.96	FSS	Summit SD LLC	03/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Rubraca (2024)

Total Spending

$31.5M

Total Claims

2,278

Beneficiaries

396

Avg Cost/Unit

$144.47

Spending Trend

$60.2M(2019)→$70.7M(2020)→$64.4M(2021)→$49.0M(2022)→$43.0M(2023)→$31.5M(2024)

YoY Change:-3.2%

5yr CAGR:+0.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

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

BIOPHORE INDIA PHARMACEUTICALS PVT LTDRUCAPARIB CAMSYLATE

DMF 423482025

FORMOSA LABORATORIES INCRUCAPARIB CAMSYLATE

DMF 344192019

MSN LABORATORIES PRIVATE LTDRUCAPARIB CAMSYLATE

DMF 355852021

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

19 patents1 exclusivity▴

TABLET;ORAL | Approved: Dec 19, 2016

Patents (19)

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

19 patents1 exclusivity▾

TABLET;ORAL | Approved: Dec 19, 2016

#003 — EQ 250MG BASE

RLD

19 patents1 exclusivity▾

TABLET;ORAL | Approved: May 1, 2017