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. One supplier is 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:	1
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

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
Rhode Island Hospital	Phase 1/Phase 2
Brown University	Phase 1/Phase 2
Bayer	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.

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
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes
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
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes			Y

Expired US Patents for RUBRACA

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

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
Ecuador	SP056094	DERIVADOS DE FTALAZINONA
Croatia	P20191944
Japan	5848728
New Zealand	601445
Ukraine	94209	ПРИМЕНЕНИЕ ИНГИБИТОРОВ РЕПАРАЦИИ ПОВРЕЖДЕНИЙ ДНК ДЛЯ ЛЕЧЕНИЯ РАКА;ЗАСТОСУВАННЯ ІНГІБІТОРІВ РЕПАРАЦІЇ ПОШКОДЖЕНЬ ДНК ДЛЯ ЛІКУВАННЯ РАКУ (DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER)

Supplementary Protection Certificates for RUBRACA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2534153	CR 2018 00041	Denmark		PRODUCT NAME: RUCAPARIB CAMSYLAT; REG. NO/DATE: EU/1/17/1250 20180529
2534153	2018/043	Ireland		PRODUCT NAME: RUCAPARIB CAMSYLATE; REGISTRATION NO/DATE: EU/1/17/1250 20180524
2534153	SPC/GB18/043	United Kingdom		PRODUCT NAME: RUCAPARIB CAMSYLATE; REGISTERED: UK EU/1/17/1250 20180529; UK PLGB 50731/0001 20180529; UK PLGB 50731/0002 20180529; UK PLGB 50731/0003 20180529
2534153	18C1049	France		PRODUCT NAME: CAMSYLATE DE RUCAPARIB; NAT. REGISTRATION NO/DATE: EU/1/17/1250 20180529; FIRST REGISTRATION: - EU/1/17/1250 20180529
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: RUBRACA (Rucaparib)

Last updated: December 31, 2025

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Executive Summary

RUBRACA (rucaparib), a PARP inhibitor developed by Clovis Oncology, has established itself within the ovarian cancer treatment landscape since its FDA approval in December 2016. Its market trajectory is influenced by evolving regulatory policies, competitive dynamics, expanding indications, and pipeline advancements. This report analyses the current market environment, evaluates financial projections, and explores the strategic factors shaping RUBRACA's future.

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Introduction

RUBRACA is an oral poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer. As a targeted therapy, it intersects with the growing precision medicine trend, positioning itself among the expanding class of PARP inhibitors, including Lynparza (olaparib) and Zejula (niraparib).

Understanding RUBRACA’s market dynamics entails reviewing the competitive landscape, regulatory developments, sales performance, pipeline progress, and macroeconomic factors influencing its trajectory.

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1. Current Market Landscape for PARP Inhibitors

Agent	Indications	Market Share (2022)	Key Features
Olaparib	Ovarian, breast, pancreatic cancers	~50%	First-in-class, multiple indications, strong brand
Niraparib	Ovarian, fallopian tube, primary peritoneal cancers	~30%	Once-daily, broad indication spectrum
Rucaparib	Recurrent ovarian, fallopian tube, peritoneal cancers	~15%	First approved for maintenance and treatment settings
Others	Talazoparib, Veliparib (clinical stage or limited approval)	<5%	Niche or investigational applications

Note: Data based on IMS Health reports (2022), with exact market shares subject to change due to expansion initiatives and pipeline entries.

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2. Regulatory and Label Expansion Strategies

Current Indications & Approvals

• FDA (2016): Recurrent ovarian cancer with deleterious BRCA mutations.
• EMA (2018): Approved for similar indications; additional approvals for maintenance therapy.
• Japan (2020): Approved for ovarian cancer.

Upcoming and Expanded Filings

• Maintenance Therapy: The SOLO2 trial led to approval for BRCA-mutated ovarian cancer maintenance therapy.
• Additional Cancer Types: Ongoing trials for prostate and breast cancers (e.g., TRITON2, ARIEL4).
• Regulatory Challenges & Delays: Potential delays in filings for broader indications due to competition and market access issues.

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3. Market Drivers and Restraints

Drivers	Restraints
Rising prevalence of ovarian and breast cancers globally	High cost of PARP inhibitors limiting access
Growing adoption of precision medicine approaches	Competition from established agents like olaparib and niraparib
Expanding clinical trials for other indications	Safety concerns, such as hematological toxicities
Strong pipeline with potential new formulations or combinations	Patent expirations, potential generics (post-2024 projections)
Favorable reimbursement policies in large markets	Regulatory hurdles in emerging markets

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4. Financial Trajectory and Sales Forecasts

Historical Financials (2016-2022)

Year	Global Sales (USD millions)	Key Markets	Growth Rate	Comments
2016	N/A (approved late in year)	U.S.	—	Minimal initial revenue
2017	~$100 million	U.S., Europe	150% growth	Rapid uptake following FDA approval
2018	~$300 million	Global	200% growth	Expanded indications and marketing efforts
2019	~$600 million	Global	100% growth	Increasing competitive pressure
2020	~$800 million	Global	33% growth	COVID-19 impact, but maintained growth
2021	~$1.2 billion	Global	50% growth	Expansion into additional indications
2022	~$1.4 billion	Global	~17% growth	Saturation in key markets, pipeline expansion begins

Note: Exact figures are sourced from Clovis Oncology financial reports and third-party analytics.

Forecasted Trajectory (2023-2028)

Year	Projected Sales (USD millions)	Assumptions
2023	~$1.6 billion	Continued growth in ovarian cancer, new indications, price adjustments
2024	~$2.0 billion	Entry into prostate cancer, pipeline approval milestones
2025	~$2.5 billion	Expanded global market access, new combination approvals
2026	~$3.0 billion	Market penetration in emerging regions, pipeline success
2027	~$3.5 billion	Competitive landscape stabilizes, revenue optimization
2028	~$4.0 billion	Potential combination therapies, label broadening incentives

Forecast methodology based on compound annual growth rate (CAGR) of 16% from 2022-2028, factoring in pipeline success probabilities and market penetration rates.

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5. Competitive Positioning and Strategic Factors

Factor	Implication for RUBRACA
Market Competition	Must differentiate via unique indications, combination therapies, or cost advantages
Pipeline Progress	Successful trials in prostate and breast cancer could unlock new markets
Pricing and Reimbursement	Adapt strategies to vary by region; negotiate value-based pricing
Patent Expirations	Patent cliff approaching (~2024-2026), potential generic competition
Strategic Partnerships	Collaborations with biotech firms for combination development

| Comparison table: Key PARP inhibitors

Attribute	RUBRACA	Lynparza	Zejula	Talazoparib
First approval	2016	2014	2017	2018
Indications	ovarian, prostate, tumor types	ovarian, breast, pancreatic	ovarian, breast	breast, ovarian
Pricing (USD)	~$10,000/month	~$13,000/month	~$12,000/month	~$15,000/month

Pricing varies by region and discount agreements.

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6. Future Outlook and Strategic Recommendations

Growth Opportunities

• Expansion into prostate, breast, and pancreatic cancers.
• Development of combination regimens with immunotherapies or targeted agents.
• Penetration into emerging markets through licensing agreements.
• Leveraging biomarker-driven indications for personalized therapy.

Risks and Challenges

• Patent expiration leading to generics.
• Increasing competitive pressure reducing market share.
• Regulatory delays impacting global rollout.
• Cost containment policies affecting reimbursement.

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7. Policy Environment and Market Access

• U.S.: Medicare & private payers increasingly favor value-based payment models.
• EU: Reimbursement linked to cost-effectiveness evaluations; NICE guidance influences uptake.
• Emerging Markets: Affordability remains a significant barrier; partnerships essential for penetration.

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Key Takeaways

• RUBRACA has established a solid market position within ovarian cancer, with ongoing expansion into prostate and breast cancers.
• Revenue growth remains robust, but patent expiries and competition necessitate strategic pipeline execution.
• Market success hinges on differentiated indications, combination therapies, and pricing strategies aligned with evolving healthcare policies.
• The drug’s future depends on pipeline milestones, regulatory approvals, and global access initiatives.
• As the PARP inhibitor class matures, RUBRACA must innovate and optimize to sustain growth.

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FAQs

Q1: What are the primary factors influencing RUBRACA's market share growth?
A1: Indication expansion, pipeline success, competitive positioning, reimbursement policies, and pricing strategies.

Q2: How does RUBRACA differentiate from other PARP inhibitors?
A2: Its initial indication for recurrent ovarian cancer and ongoing trials in prostate and breast cancers; potential advantages include oral administration and specific biomarker responsiveness.

Q3: What are the potential challenges to RUBRACA's growth?
A3: Patent expirations, increasing competition, regulatory bottlenecks, and cost containment policies could limit access and pricing power.

Q4: How significant are upcoming pipeline developments for RUBRACA?
A4: Very significant—successful trials in other cancers and combination therapies could dramatically expand its market potential.

Q5: What strategic moves could enhance RUBRACA's market presence?
A5: Broadening indications, establishing partnerships in emerging markets, developing combination regimens, and optimizing pricing strategies.

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References

[1] Clovis Oncology. (2022). Annual Financial Report.
[2] IMS Health. (2022). Market Analysis Reports.
[3] FDA. (2016). Approval announcement for RUBRACA.
[4] EMA. (2018). Drug Summary for RUBRACA.
[5] ClinicalTrials.gov. (2022). Ongoing trials involving rucaparib.

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Note: all projections and analyses are subject to change based on market developments, regulatory decisions, and clinical trial outcomes.