RUCAPARIB CAMSYLATE - Generic Drug Details

What are the generic drug sources for rucaparib camsylate and what is the scope of freedom to operate?

Rucaparib camsylate is the generic ingredient in one branded drug marketed by Pharmaand and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rucaparib camsylate has two hundred and forty patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for RUCAPARIB CAMSYLATE

International Patents:	240
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RUCAPARIB CAMSYLATE
DailyMed Link:	RUCAPARIB CAMSYLATE at DailyMed

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

Constraining patent/regulatory exclusivity:

9,987,285

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 RUCAPARIB CAMSYLATE

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

Sponsor	Phase
Alliance for Clinical Trials in Oncology	Phase 3
National Cancer Institute (NCI)	Phase 3
Clovis Oncology, Inc.	Phase 2

See all RUCAPARIB CAMSYLATE clinical trials

Pharmacology for RUCAPARIB CAMSYLATE

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

Anatomical Therapeutic Chemical (ATC) Classes for RUCAPARIB CAMSYLATE

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for RUCAPARIB CAMSYLATE

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	209115-001	Dec 19, 2016		RX	Yes	No	8,071,579
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	9,861,638
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	8,143,241
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	10,130,636

Expired US Patents for RUCAPARIB CAMSYLATE

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 RUCAPARIB CAMSYLATE

Country	Patent Number	Title	Estimated Expiration
Serbia	55487	SOLI I POLIMORFI 8-FLUORO-2-{4-[(METILAMINO}METIL]FENIL}-1,3,4,5-TETRAHIDRO-6H-AZEPINO[5,4,3-CD]INDOL-6-ONA (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)
Japan	2020050671	８−フルオロ−２−｛４−［（メチルアミノ）メチル］フェニル｝−１，３，４，５−テトラヒドロ−６Ｈ−アゼピノ［５，４，３−ｃｄ］インドール−６−オンの塩および多形体 (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)
Canada	2547077	INHIBITEURS DE REPARATION D'ADN ENDOMMAGE POUR LE TRAITEMENTDU CANCER (DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER)
Cyprus	2018031

Supplementary Protection Certificates for RUCAPARIB CAMSYLATE

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 Rucaparib Camsylate

Last updated: July 28, 2025

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Introduction

Rucaparib camsylate, marketed under the brand name Rubraca, is a PARP (Poly ADP-Ribose Polymerase) inhibitor approved primarily for ovarian, prostate, and recently, other solid tumors. As a targeted therapy, it exemplifies the shift towards precision medicine in oncology. Understanding its market dynamics and financial trajectory involves analyzing regulatory developments, competitive landscape, patent statuses, manufacturing considerations, and market adoption trends.

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Regulatory Landscape and Market Entry

Rucaparib received FDA approval in December 2016 for maintenance treatment of recurrent ovarian cancer and subsequently expanded indications to include treatment of BRCA-mutant prostate cancer in 2020. The European Medicines Agency (EMA) granted marketing authorization in March 2018 for ovarian cancer. The drug's approval trajectory has been bolstered by robust clinical trial data demonstrating efficacy in homologous recombination deficiency (HRD) cancers (e.g., [1]).

Emerging regulatory signals, especially approval pathways for novel indications, influence the drug’s market penetration. Notable is the recent approval of additional indications in various jurisdictions, expanding potential patient pools, and validating the drug’s therapeutic potential.

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Market Demand and Patient Population Dynamics

The global ovarian cancer market was valued at approximately $2 billion in 2022, with PARP inhibitors constituting a significant share [2]. Rucaparib targets BRCA-mutant and HRD-positive populations, which, although smaller, demonstrate high response rates, supporting targeted market expansion.

The prostate cancer market for PARP inhibitors, including rucaparib, is relatively nascent but growing, driven by increased biomarker testing and precision medicine initiatives. The rising prevalence of metastatic castration-resistant prostate cancer (mCRPC) correlates with increased demand for PARP inhibitors like rucaparib, forecasted to grow at a CAGR of 12-15% over the next five years [3].

The productivity of market penetration hinges on mutation testing infrastructure. As next-generation sequencing (NGS) becomes mainstream, identifying eligible patients enhances prescription rates, propelling rucaparib’s sales.

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Competitive Landscape

The PARP inhibitor market is fiercely competitive, dominated by olaparib (Lynparza, AstraZeneca), niraparib (Zejula, GSK), and talazoparib (Talzenna, Pfizer). Rucaparib's competitive edge derives from its clinical efficacy, safety profile, and strategic positioning for specific genetic backgrounds.

However, access to clinical data, pricing strategies, and regulatory endorsements influence market share. For instance, olaparib, being first approved, has a significant head start, but rucaparib maintains a niche for certain BRCA-mutant ovarian cancers. Continuous clinical trials and label expansions are essential to increase market share.

Market consolidation and partnership activities also influence the competitive landscape, with clinical and commercial collaborations working to broaden indications and streamline distribution.

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Patent, Pricing, and Reimbursement Strategies

Patent protection extends into the early 2030s, securing exclusivity during a critical growth phase (subject to patent litigation and possible extensions). This ensures initial high-margin revenue streams, especially in mature markets like the US and EU.

Pricing strategies are aligned with value-based models, leveraging the drug’s targeted efficacy. Reimbursement negotiations are pivotal; payer acceptance hinges on demonstrating clinical benefit-cost ratios. Value-based agreements or managed access schemes are increasingly prevalent.

Cost of goods (COGS) remains moderate due to scalable manufacturing processes, but R&D investments and regulatory compliance significantly influence overall financial trajectory.

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Manufacturing and Supply Chain Considerations

Manufacturing of rucaparib entails complex process chemistry typical of small molecules. Ensuring quality control, consistent supply, and scalability are essential for meeting global demand.

Supply chain resilience impacts sales, especially amid global disruptions such as pandemics. Strategic manufacturing partnerships and geographic diversification mitigate risks.

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Financial Performance and Future Outlook

Historically, Rubraca’s revenue has ranged between $150-200 million annually (pre-2022 data), with recent growth driven by indication expansions and increased demand in prostate cancer [4]. The introduction of new formulations, such as combination therapies with immune checkpoint inhibitors, could further elevate sales.

Forecasting indicates sustained growth, particularly with ongoing clinical trials exploring adjuvant, combination, and novel indication pathways. Market penetration depends heavily on the validation of efficacy in broader cancer subtypes and the refinement of biomarker testing.

Projected compounded annual growth rate (CAGR) for rucaparib sales is estimated at 10%-13% over the next five years, driven by expanding indications, therapy penetration, and escalated mutation testing.

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Challenges and Opportunities

Challenges:

• Competition from established PARP inhibitors with larger global footprints.
• Patent expiration risks and biosimilar entry prospects.
• Variability in reimbursement policies across regions.
• Manufacturing complexities impacting supply consistency.

Opportunities:

• Expanding into combination therapies with immunotherapies.
• Investigating new oncology indications, such as breast and pancreatic cancers.
• Adoption of companion diagnostics to personalize therapy.
• Strategic collaborations to accelerate development and commercialization.

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Key Takeaways

• Rucaparib's market growth hinges on expanding indications, patient identification, and competitive positioning against broader PARP inhibitor portfolios.
• Increasing biomarker-driven testing enhances patient eligibility, crucial in both ovarian and prostate cancers.
• Patent protections secure revenue streams during high-growth periods; impending patent expirations may challenge future profitability.
• Production scalability and supply chain robustness are vital to meet the rising global demand.
• Strategic initiatives, including combination therapies and new indications, are critical to sustaining and increasing the drug’s market share.

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FAQs

1. What are the primary indications for rucaparib?
Rucaparib is approved for maintenance treatment of recurrent ovarian cancer with BRCA mutations, and for metastatic castration-resistant prostate cancer with homologous recombination deficiency mutations.

2. How does rucaparib differentiate from other PARP inhibitors?
While all PARP inhibitors target DNA repair pathways, rucaparib’s differentiation lies in its specific clinical trial data, safety profile, and approved indications. Its particular chemical and pharmacokinetic properties also influence its niche positioning.

3. What is the outlook for rucaparib in expanding into new cancer types?
Clinical trials are ongoing to explore efficacy in breast, pancreatic, and other solid tumors. Success in these areas could substantially expand its market.

4. How do patent protections influence the drug’s financial trajectory?
Patent protections up to early 2030s secure exclusivity, enabling premium pricing and market control. Patent challenges or biosimilars could erode revenue streams.

5. What market strategies are critical for rucaparib’s growth?
Targeted biomarker testing, combination therapies, strategic partnerships, and expanding indications are pivotal strategies for sustained growth.

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References

[1] American Cancer Society. "Targeted therapies for ovarian cancer." 2022.
[2] MarketWatch. "Global ovarian cancer market size and forecast." 2022.
[3] Grand View Research. "Prostate cancer therapeutics market analysis." 2023.
[4] Company financial disclosures. Rucaparib sales data, 2022.