RUBRACA Drug Patent Profile

Which patents cover Rubraca, and when can generic versions of Rubraca launch?

Rubraca is a drug marketed by Pharmaand and is included in one NDA. There are nine patents protecting this drug.

This drug has two hundred and forty patent family members in forty-four countries.

The generic ingredient in RUBRACA is rucaparib camsylate. Two suppliers are listed for this compound. Additional details are available on the rucaparib camsylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Rubraca

Rubraca was eligible for patent challenges on December 19, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 17, 2035. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for RUBRACA

International Patents:	240
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	21
Drug Prices:	Drug price information for RUBRACA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RUBRACA
What excipients (inactive ingredients) are in RUBRACA?	RUBRACA excipients list
DailyMed Link:	RUBRACA at DailyMed

See drug prices for RUBRACA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RUBRACA

Constraining patent/regulatory exclusivity:

9,987,285

NDA:

209115

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RUBRACA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The Miriam Hospital	Phase 1/Phase 2
Rhode Island Hospital	Phase 1/Phase 2
Brown University	Phase 1/Phase 2

See all RUBRACA clinical trials

Pharmacology for RUBRACA

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

US Patents and Regulatory Information for RUBRACA

RUBRACA is protected by nineteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,987,285.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	9,861,638
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	8,071,579
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	8,859,562

Expired US Patents for RUBRACA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017	7,531,530
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016	7,531,530
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016	6,495,541
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017	6,495,541

International Patents for RUBRACA

When does loss-of-exclusivity occur for RUBRACA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

New Zealand

Russian Federation

Singapore

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RUBRACA around the world.

Country	Patent Number	Title	Estimated Expiration
Iceland	8052	Þalazínónafleiður
Australia	2010202197	DNA damage repair inhibitors for treatment of cancer
South Korea	20060123403	DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER
China	102884066	Salts and polymorphs of 8-fluoro-2-{4-[(methylamino}methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one

Supplementary Protection Certificates for RUBRACA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	15C0022	France		PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
2534153	C201830056	Spain		PRODUCT NAME: CAMSILATO DE RUCAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1250; DATE OF AUTHORISATION: 20180524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1250; DATE OF FIRST AUTHORISATION IN EEA: 20180524
1633724	CR 2015 00012	Denmark		PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
2534153	2018/043	Ireland		PRODUCT NAME: RUCAPARIB CAMSYLATE; REGISTRATION NO/DATE: EU/1/17/1250 20180524

Market Dynamics and Financial Trajectory for RUBRACA (Rucaparib)

Last updated: July 27, 2025

Introduction

RUBRACA (rucaparib) is an oral poly(ADP-ribose) polymerase (PARP) inhibitor developed by Clovis Oncology, designed to target cancers with homologous recombination deficiency (HRD), notably ovarian, prostate, and other solid tumors. Since its approval by the U.S. Food and Drug Administration (FDA) in December 2016 for advanced ovarian cancer, RUBRACA has established itself as a pivotal therapy within the expanding PARP inhibitor market. Analyzing its market dynamics and financial trajectory reveals insights into its growth potential, competitive landscape, and future revenue outlook amidst changing pharmaceutical trends.

Market Landscape and Demand Drivers

Expanding Therapeutic Indications

Initially approved for ovarian cancer patients with BRCA mutations, RUBRACA’s approved indications have broadened. In 2020, Clovis extended its use to include maintenance treatment for recurrent ovarian cancer in patients with platinum-sensitive disease after response to platinum chemotherapy, regardless of BRCA status, aligning with the increasing recognition of HRD's role in therapy response [1]. Furthermore, in 2020, the FDA approved RUBRACA for metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair gene mutations, marking its entry into the prostate cancer segment and diversifying revenue streams.

Growth of PARP Inhibitor Class

The global PARP inhibitor market increased from an estimated USD 2.3 billion in 2020 to USD 4.2 billion in 2022, driven by rising adoption across ovarian, prostate, and breast cancers [2]. Competition, primarily from Lynparza (olaparib), Talzenna (talazoparib), and newer entrants, necessitates continuous clinical and regulatory progress for RUBRACA to maintain market share.

Geographic Expansion and Market Penetration

Clovis Oncology has prioritized U.S. commercialization, with expanding access in Europe and select Asian markets. Market penetration remains robust in regions with well-established testing infrastructure for BRCA and HRD mutations, essential for determining eligibility for PARP inhibitor therapies.

Reimbursement and Pharmacoeconomics

Reimbursement strategies heavily influence sales. In the U.S., RUBRACA benefits from managed care agreements and national guidelines recognizing PARP inhibitors' clinical efficacy. Payor acceptance correlates with the drug’s demonstrated survival benefits and its positioning relative to competitors.

Competitive Landscape and Market Dynamics

Key Competitors

• Lynparza (olaparib): Approved across ovarian, prostate, breast, and pancreatic cancers, with extensive clinical data supporting multiple indications [3].
• Talzenna (talazoparib): Focused on breast and ovarian cancers, positioned as a potent PARP inhibitor.
• Other emerging agents: Niraparib (Zejula) and veliparib are expanding the class’s reach with confirmed efficacy.

Differentiators and Challenges

While these agents share a common mechanism, differences in potency, side-effect profiles, and regulatory approvals influence market share. RUBRACA faces challenges due to the crowded market and the need to demonstrate distinct clinical benefits or cost advantages.

Regulatory and Clinical Pipeline Development

Ongoing trials aim to expand indications, including combination therapies with immune checkpoint inhibitors and chemotherapeutic agents, potentially enhancing efficacy and broadening its clinical applicability. Regulatory approvals in emerging markets can significantly enhance market size.

Financial Trajectory and Revenue Analysis

Historical Financial Performance

Clovis Oncology reported revenues of approximately USD 50 million in 2021, primarily driven by RUBRACA sales, marking steady growth from initial launch revenues of USD 37 million in 2017. Despite increasing sales, profitability remains challenged by high R&D and commercialization costs, compounded by competition and reimbursement barriers.

Forecasted Revenue Growth

Analysts project that RUBRACA’s global sales could reach USD 200–250 million by 2025, assuming successful market expansion, broader indications, and increased adoption in prostate and other cancers [4]. The potential for combination therapies, which could command premium pricing, offers avenues for revenue uplift.

Market Penetration Factors Influencing Financial Trajectory

• Clinical outcomes: Demonstration of superior or additive benefits in combination regimes could accelerate adoption.
• Pricing and reimbursement: Negotiations with payors and health authorities will shape revenue realizations.
• Pipeline advancement: FDA and EMA approval of new indications and ongoing clinical trials could materially influence future sales.
• Generic competition: Patent expirations, anticipated around 2028, pose potential risks of revenue erosion.

Future Outlook and Strategic Considerations

Opportunities

• Diversification into combination therapies with immunotherapies could redefine RUBRACA’s position.
• Expanding indications into other HRD-associated tumors offers revenue diversification.
• Market penetration in Asia and Latin America, where kinship with genetic testing infrastructure exists, could significantly augment sales.

Risks

• Competitive pressures from AT- and PTEN-targeted therapies.
• Cost-containment measures in healthcare systems could limit reimbursement.
• The patent cliff remains a pressing concern, necessitating innovation and pipeline development.

Key Takeaways

• RUBRACA’s market growth hinges on expanding indications and geographic reach, compounded by evolving clinical data.
• The competitive landscape remains intense, yet opportunities in combination therapies and pipeline investments could propel future revenues.
• Reimbursement policies and clinical test accessibility will continue to influence adoption trajectories.
• Despite current financial challenges, strategic expansion and pipeline advancement hold promise for securing RUBRACA’s long-term market position.
• Investors and stakeholders should monitor regulatory approvals, clinical trial outcomes, and patent status to gauge future growth.

FAQs

1. What are the primary indications currently approved for RUBRACA?
RUBRACA is approved for treatment of advanced ovarian cancer with BRCA mutations, maintenance therapy for recurrent ovarian cancer regardless of BRCA status, and mCRPC with homologous recombination repair gene mutations.

2. How does RUBRACA compare to its competitors in efficacy and safety?
Clinical trials suggest similar efficacy among PARP inhibitors, with differences in side-effect profiles and dosing. RUBRACA's safety profile includes manageable hematological toxicities, comparable to other class members.

3. What are the prospects for RUBRACA in expanding into other solid tumors?
Ongoing trials investigate its efficacy in pancreatic, breast, and other cancers with HRD, potentially broadening its market footprint.

4. How might patent expirations impact RUBRACA’s future revenues?
Patent expiration around 2028 could lead to generic competition, emphasizing the need for pipeline innovation and new indications to sustain revenues.

5. What strategic moves could enhance RUBRACA's market position?
Clinical success in combination therapies, global regulatory approvals, cost-effective reimbursement strategies, and pipeline expansion are pivotal to strengthening its competitive stance.

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References

[1] U.S. Food and Drug Administration. (2016). FDA approves rucaparib for ovarian cancer.
[2] MarketResearch.com. (2022). Global PARP inhibitors market analysis.
[3] European Medicines Agency. (2020). Summary of product characteristics for Lynparza.
[4] GlobalData. (2022). PARP inhibitors market outlook and forecasts.