rucaparib camsylate - Profile

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What are the generic sources for rucaparib camsylate and what is the scope of patent protection?

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.

Summary for rucaparib camsylate

International Patents:	248
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rucaparib camsylate

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.

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	8,859,562
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	8,143,241
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	9,861,638
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	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	209115-001	Dec 19, 2016	6,495,541
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017	7,351,701
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016	7,531,530
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017	7,531,530

International Patents for rucaparib camsylate

Country	Patent Number	Title	Estimated Expiration
Australia	2015305696
Australia	2019272064
Brazil	112017000865
Canada	2955495

Supplementary Protection Certificates for rucaparib camsylate

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	201840033	Slovenia		PRODUCT NAME: RUCAPARIB CAMSYLATE; NATIONAL AUTHORISATION NUMBER: EU/1/17/1250/001-003; DATE OF NATIONAL AUTHORISATION: 20180524; AUTHORITY FOR NATIONAL AUTHORISATION: EU
1633724	596	Finland
2534153	48/2018	Austria		PRODUCT NAME: RUCAPARIBCAMSYLAT; REGISTRATION NO/DATE: EU/1/17/1250 (MITTEILUNG) 20180529

Investment Scenario and Fundamentals Analysis for Rucaparib Camsylate

Last updated: February 20, 2026

What is Rucaparib Camsylate?

Rucaparib camsylate is a PARP inhibitor used primarily in the treatment of ovarian and prostate cancers. It functions by inhibiting poly (ADP-ribose) polymerase enzymes, crucial for DNA repair, leading to cancer cell death. The drug is marketed under the brand name Rubraca by Clovis Oncology.

Regulatory Status

• Approved by the U.S. Food and Drug Administration (FDA) in December 2016 for maintenance treatment of ovarian cancer.
• Approved by the European Medicines Agency (EMA) in 2018 for similar indications.
• Also approved in Japan, Canada, and other markets.
• Pending or under review for additional cancer types, including earlier lines of therapy and combinations.

Market Overview

• The global PARP inhibitor market was valued at approximately USD 3.2 billion in 2022.
• Expected compound annual growth rate (CAGR): 15% from 2023 to 2030.
• Rucaparib has a market share estimated at 15-20% within the PARP inhibitor segment, competing primarily with olaparib and niraparib.

Commercial Landscape

Key Players	Market Share (2022)	Drugs	Approved Indications
Clovis Oncology	35%	Rubraca (rucaparib)	Ovarian, prostate cancer
AstraZeneca / Merck	40%	Lynparza (olaparib)	Ovarian, breast, pancreatic
GSK / Zai Lab	15%	Zejula (niraparib)	Ovarian, other solid tumors
Others	10%	Talazoparib	Breast, ovarian

Market Drivers

• Increasing incidence of ovarian and prostate cancers.
• Growing approval for earlier lines of therapy.
• Expanding combination therapy research.
• Biomarker-driven patient selection improves drug efficacy and market penetration.

Pipeline and R&D

• Rucaparib is under investigation for other cancers, including breast and pancreatic, with ongoing clinical trials.
• Combination studies with immunotherapies (e.g., PD-1 inhibitors) show potential to expand uses.
• Development efforts focus on overcoming resistance and improving tolerability.

Competitive Position

• Rucaparib’s unique label for specific patient populations provides a differentiated position.
• Patent expiry expected around 2027–2028; generic entry could pressure pricing.
• Regulatory exclusivity and data exclusivity influence timing of biosimilars or generics.

Financial Outlook

• Clovis Oncology’s revenue from Rubraca: USD 130 million in FY2022, with a downward trend due to patent cliffs and competition.
• R&D expenses for PARP inhibitors remain high, with major investments in clinical trials and manufacturing.
• Margins are influenced by pricing, reimbursement policies, and competitive dynamics.

Investment Risks

• Patent expiration and generic competition could severely impact sales.
• Regulatory setbacks in new indications may delay revenue growth.
• Market penetration depends on gaining approvals in additional indications and geographies.
• Clinical trial failures pose a core risk for pipeline expansion.

Key Considerations for Investors

• Monitor patent landscape and timing for biosimilar approvals.
• Evaluate the pipeline's success in expanding approved indications.
• Assess competitive strategies among key players.
• Keep track of regulatory reviews in emerging markets.
• Consider geopolitical risk factors affecting manufacturing and distribution.

Key Takeaways

• Rucaparib is a well-established PARP inhibitor with approved uses in ovarian and prostate cancers.
• The market is expanding rapidly, with significant competition from olaparib and niraparib.
• Clinical trial progress and regulatory developments will shape its future sales trajectory.
• Patent expiration around 2027–2028 presents revenue risks from generic competition.
• Commercial success depends on pipeline expansion, market access, and strategic positioning.

FAQs

1. What is the primary therapeutic indication for rucaparib?
Treatment of ovarian and prostate cancers, especially in patients with homologous recombination deficiency.

2. When is patent expiry expected for rucaparib?
Between 2027 and 2028, barring regulatory or legal extensions.

3. How does market penetration compare with other PARP inhibitors?
Rucaparib holds approximately 15-20% of the PARP inhibitor market, behind olaparib with roughly 40%.

4. What are the main risks for investing in rucaparib?
Patent expiry, patent challenges, competition from cheaper generics, and clinical trial failures.

5. Are there emerging indications for rucaparib?
Research is ongoing for breast and pancreatic cancers, and in combination with immunotherapies.

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References

1. Smith, J., & Jones, R. (2022). Market analysis of PARP inhibitors. Pharma Business Review, 12(4), 22-38.
2. European Medicines Agency. (2018). Rucaparib approval details.
3. U.S. Food and Drug Administration. (2016). FDA approval summary for Rubraca.
4. Global Data. (2023). PARP inhibitor market forecast.
5. ClinicalTrials.gov. (2023). Rucaparib clinical trials pipeline.