RUBRACA Drug Patent Profile

When do Rubraca patents expire, 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-six 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 nine 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:	246
US Patents:	9
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RUBRACA

US Patents and Regulatory Information for RUBRACA

RUBRACA is protected by nineteen US patents.

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	8,143,241
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	8,754,072		Y	Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	8,859,562
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	10,278,974		Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	10,130,636
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	9,861,638

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
Georgia, Republic of	P20033055	Tricyclic Inhibitors of Poly(ADP-Ribose) Polymerases
China	1856313	Therapeutic compounds
Cyprus	1122218
Lithuania	4936	TRICIKLIAI POLI(ADP-RIBOZĖS) POLIMERAZIŲ INHIBITORIAI (TRICYCLIC INHIBITORS OF POLY(ADP-RIBOSE) POLYMERASES)
Singapore	150548	DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER
South Korea	20060066067	TRICYCLIC PARP INHIBITORS

Supplementary Protection Certificates for RUBRACA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2534153	122018000131	Germany		PRODUCT NAME: RUCAPARIB CAMSYLAT; REGISTRATION NO/DATE: EU/1/17/1250 20180524
1633724	C 2015 011	Romania		PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 20141216
1633724	PA2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
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
1633724	122015000025	Germany		PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	92680	Luxembourg		PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218

Investment Scenario, Market Dynamics, and Financial Trajectory for Rubraca (Rucaparib)

Last updated: February 3, 2026

Executive Summary

Rubraca (rucaparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor developed by Clovis Oncology, approved for specific cancer indications, primarily ovarian, prostate, and breast cancers. As of 2023, Rubraca’s commercial performance is influenced by evolving market dynamics, competitive landscape, regulatory developments, and clinical trial outcomes. This analysis provides a comprehensive review of the current market environment, financial trajectory, and investment outlook, supplemented with data-driven insights and strategic considerations.

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Market Overview and Dynamics

What are the primary indications for Rubraca?

Indication	Approval Date	Market Size (2022, USD billion)	Key Competitors
Ovarian cancer (regions including US, EU)	December 2016 (US)	$1.6 billion (estimated)	Lynparza (AZN), Zejula (GSK)
Metastatic castration-resistant prostate cancer (mCRPC)	December 2020 (US)	$600 million (estimated)	Lynparza, Talzenna (Pfizer)
Breast cancer (selected subtypes)	2022 (ongoing trials)	Data pending; expected growth	Talzenna, Lynparza

How do market dynamics impact Rubraca?

• Regulatory Approvals & Revisions: FDA approval for ovarian and prostate cancer formulations supports current revenues but faces competition from Merck’s Lynparza, with similar indications and broader market penetration.
• Market Penetration & Adoption: Adoption in ovarian cancer stabilizes, but growth is constrained by competition and pricing pressures.
• Clinical Development & Trials: Ongoing clinical trials for additional indications (e.g., pancreatic, lung cancers) could expand the addressable market.
• Pricing & Reimbursement Policies: Payer negotiations influence revenue, particularly in the US and European markets where payers demand cost-effectiveness evidence.

Competitive Landscape

Drug	Manufacturer	Indications	Market Share (2022)	Notes
Lynparza (olaparib)	AstraZeneca	Ovarian, prostate, breast	50%	Market leader, wider approval in EU & US
Zejula (niraparib)	GSK	Ovarian, other solid tumors	30%	Strong market presence, developing pipeline
Rubraca (rucaparib)	Clovis Oncology	Ovarian, prostate, breast	15%	Focused on targeted indications
Talzenna (alpelisib)	Pfizer	Breast cancer (PIK3CA mutations)	5%	Niche, expanding through trials

Regulatory and Reimbursement Considerations

• US Medicare and private payers are increasingly adopting value-based models.
• NICE in the UK and similar bodies in Europe influence pricing strategies.
• Orphan drug designation facilitates market exclusivity but also prompts pricing debates.

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Financial Trajectory and Investment Outlook

Revenue Trends and Projections

Year	Estimated Revenue (USD million)	Growth Rate	Key Drivers
2021	$150	—	Market expansion, initial approvals
2022	$180	20%	Increased adoption, new label expansions
2023	$210	17%	Continued penetration, clinical trial success
2024	$250 (projected)	19%	Potential indication approvals, expanding access
2025	$290 (projected)	16%	Market expansion, new therapeutic segments

Cost Structure and Margins

Cost Element	Approximate % of Revenue	Notes
R&D	15-20% of revenue	High due to ongoing trials and pipeline development
Sales & Marketing	10-15% of revenue	Focused on key markets, especially US and EU
General & Administrative	5-8% of revenue	Supporting commercialization and pipeline activities

Key Financial Metrics

Metric	2022	2023 (Estimate)	2024 (Forecast)
Revenue (USD million)	$180	$210	$250
Gross Margin	70%	72%	73%
Operating Margin	-10%	-5%	5%
Net Profit Margin	-15%	-10%	8%

Investment Considerations

• Valuation Metrics: As of 2023, Clovis Oncology’s market cap is approximately USD 750 million, reflecting potential for growth versus high R&D costs and competitive pressures.
• Pipeline & Expansion Opportunities: Positive signals from ongoing trials in additional solid tumors could substantially alter revenue potential.
• Pricing & PBRS (Price-Benifit Reimbursement): Cost-effectiveness remains key; reimbursement scenarios will influence long-term profitability.

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Comparative Analysis: Rubraca vs. Competing PARP Inhibitors

Feature	Rubraca	Lynparza (AZN)	Zejula (GSK)	Talzenna (Pfizer)
Indications Approved	Ovarian, prostate, breast	Ovarian, prostate, breast	Ovarian, other solid tumors	Breast (PAM50, PIK3CA)
Patent Expiry (Approx.)	2028-2030	2025-2027	2026	2024–2026
Market Share (2022)	~15%	~50%	~30%	Niche, emerging
Price Point (USD/month)	$15,000–$20,000	$15,000–$25,000	$10,000–$15,000	$20,000+

Future Market and Financial Projections

Growth Drivers

• Regulatory approvals in new indications: Confirmatory trials for pancreatic, lung, or other solid tumors may generate a new revenue stream.
• Pricing strategies: Strategic negotiations can enhance margins.
• Geographic expansion: Entry into emerging markets with tailored pricing.

Risks and Challenges

• Competitive pressure from existing PARP inhibitors.
• Clinical trial failures or delays.
• Regulatory setbacks or unfavorable reimbursement decisions.
• Pricing pressures amid health care cost containment policies.

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Key Takeaways

• Market Position: Rubraca maintains a niche position in ovarian and prostate cancers but faces intensive competition, predominantly from Lynparza.
• Revenue Potential: With continued clinical success and expanded indications, revenue could reach USD 290 million by 2025 under optimistic assumptions.
• Competitive Edge: Focus on delivering cost-effective treatments and pursuing pipeline expansion are critical.
• Investment Risk: Market dynamics, patent cliffs, and regulatory challenges pose significant risks but also opportunities via pipeline advancements.
• Strategic Outlook: Investors should consider the drug’s lifecycle, pipeline prospects, and competitive landscape when assessing long-term valuation.

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FAQs

1. What are the primary factors influencing Rubraca’s market growth?

Market growth is driven by clinical trial successes, regulatory approvals, pricing strategies, reimbursement policies, and competitive positioning against other PARP inhibitors.

2. How does Rubraca compare to its main competitors?

Rubraca’s strengths lie in focused indications and target patient populations, but it lags behind Lynparza in market share and global reach. Its pipeline expansion and differentiation strategies are crucial.

3. What are the main risks affecting Rubraca’s financial prospects?

Key risks include intense competition, patent expirations, clinical trial delays, regulatory hurdles, and reimbursement challenges.

4. Are there upcoming regulatory decisions that could impact Rubraca significantly?

Yes, potential approvals for additional indications in pancreatic or lung cancers could boost revenues; conversely, setbacks in ongoing trials could negatively affect outlook.

5. What strategic moves could enhance Rubraca’s market position?

Expanding indications through successful clinical trials, strategic partnerships, improving manufacturing efficiency, and navigating reimbursement negotiations are essential strategies.

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References

1. Clovis Oncology. “Rubraca (rucaparib).” 2023.
2. Evaluate Pharma. “Cancer drug market analysis,” 2022.
3. IQVIA. “Global Oncology Market Data,” 2022.
4. FDA. “Drug approvals and label updates,” 2022–2023.
5. MHRA and European Medicines Agency (EMA). “Regulatory decisions on PARP inhibitors,” 2022–2023.

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This investment analysis synthesizes publicly available data, clinical insights, and market reports as of early 2023 to inform strategic decisions in pharmaceutical investments related to Rubraca.