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-six patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for RUCAPARIB CAMSYLATE

International Patents:	246
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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

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
National Cancer Institute (NCI)	Phase 3
Alliance for Clinical Trials in Oncology	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			Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No			Y

Expired US Patents for RUCAPARIB CAMSYLATE

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

International Patents for RUCAPARIB CAMSYLATE

Country	Patent Number	Title	Estimated Expiration
Brazil	112012019050	sai e polimorfos de 8-fluoro-2-{metilamino)metil]fenil}-1,3,4,5-tetra-hidro-6h-azepino[5,4,3cd]indo-6-ona.
European Patent Office	4166558	SELS ET POLYMORPHES DE 8-FLUORO-2-{4-[(MÉTHYLAMINO} MÉTHYL] PHÉNYL}-1 ,3,4,5-TETRAHYDRO-6H-AZEPINO[5,4,3- CD]INDOL-6-ONE (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)
San Marino	T201600462	SALI E POLIMORFI DI 8-FLUORO-2-{4-[(METILAMMINO)METIL]FENIL}-1,3,4,5-TETRAIDRO-6H-AZEPINO [5,4,3-CD] INDOL-6-ONE

Supplementary Protection Certificates for RUCAPARIB CAMSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2534153	48/2018	Austria		PRODUCT NAME: RUCAPARIBCAMSYLAT; REGISTRATION NO/DATE: EU/1/17/1250 (MITTEILUNG) 20180529
2534153	122018000131	Germany		PRODUCT NAME: RUCAPARIB CAMSYLAT; 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

RUCAPARIB CAMSYLATE Market Analysis and Financial Projection

Last updated: February 13, 2026

What are the market dynamics for rucaparib camsylate?

Rucaparib camsylate is a PARP inhibitor marketed under the brand name Rubraca by Clovis Oncology. It is primarily used to treat ovarian, prostate, and other cancers associated with homologous recombination deficiency (HRD) and BRCA mutations.

Market Size and Growth Drivers

The global PARP inhibitor market was valued at approximately $4.2 billion in 2022 and projects a compound annual growth rate (CAGR) of 18-20% through 2028 [1]. Rucaparib accounts for a significant share due to its approvals across multiple indications.

Key drivers include:

• Expanding FDA approvals: Rucaparib is approved for ovarian cancer (maintenance and treatment settings), prostate cancer, and other indications.
• Growing prevalence of ovarian and prostate cancers: ovarian cancer affects roughly 19,880 women in the US annually; prostate cancer affects over 174,000 men in the US annually [2].
• Advances in biomarker testing: Increased testing for BRCA mutations enhances patient eligibility.
• Pricing and reimbursement: High drug prices (approx. $13,000 per month in the US) support revenue growth, contingent on payer coverage.

Competitive Landscape

Major competitors include:

• Olaparib (Lynparza) by AstraZeneca
• Niraparib (Zejula) by Tesaro (GSK)
• Talazoparib (Talzenna) by Pfizer

These agents differ in indications, approval status, and pricing, influencing market share dynamics.

Regulatory and Market Expansion

Recent approvals in non-ovarian indications, such as castration-resistant prostate cancer, broaden market potential. Regulatory initiatives in Europe and Asia aim to expand access, contingent on local reimbursement policies.

Challenges and Risks

• Pricing pressure: Payers demand value-based pricing, affecting revenue.
• Competition: Olaparib dominates early-stage breast and ovarian treatments, while Niraparib offers a broader indication footprint.
• Market penetration delays: Limited awareness and diagnostic gaps slow uptake in emerging markets.

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What is rucaparib’s financial trajectory?

Revenue and Sales Trends

Clovis Oncology reported:

Fiscal Year	Total Rucaparib Revenue	Year-over-Year Change	Key Growth Factors
2020	$305 million	N/A	Launch of US ovarian cancer indication
2021	$338 million	10.5% increases	Expanded approvals; increased market penetration
2022	$362 million	7.1% increase	Growth in prostate cancer segment
2023 (Q1-Q3)	$270 million (estimated)	—	Market saturation; competitive pressures

Revenue growth has demonstrated moderate expansion, driven mostly by expanding indications and geographic expansion. However, high pricing costs are offset by payer negotiations and access limitations.

Profitability and Cost Structure

• Gross margins have hovered around 80%, with gross profit margins increasing alongside revenue.
• Research and Development (R&D): In 2022, R&D expenses reached approximately $130 million, representing about 36% of total operational costs.
• Operational costs: Selling, general, and administrative expenses (SG&A) remained around $90 million annually.

Future Revenue Projections

Assuming:

• Continued expansion into prostate and other solid tumors.
• Increased market penetration in Europe and Asia.
• Introduction of companion diagnostics reduces off-label prescriptions.

Analysts estimate 2024 revenues could reach $400-450 million, with potential upside if new indications or combination therapies are approved.

Key Factors Influencing Financial Trajectory

• FDA approvals in new indications and line extensions.
• Market access strategies in emerging economies.
• Price negotiations that could moderate revenue growth.
• Competitive developments especially Olaparib's leadership position.

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What are the regulatory and licensing implications?

• Regulatory approvals in multiple regions are critical for revenue expansion.
• Patent status: Rucaparib’s composition of matter patents expiry is projected around 2030, with some formulation patents lasting until 2035.
• Orphan designation: The ovarian cancer indication received orphan status, offering exclusivity until 2027.

Key Takeaways

• Rucaparib competes in a fast-growing PARP inhibitor market with rising off-label use.
• Revenue growth remains moderate under extensive competition and payer pressures.
• Expansion into prostate and other cancers presents significant upside.
• Patent protections and regulatory approvals remain critical to revenue stability.
• Pricing negotiations will impact future profitability and access.

FAQs

1. How does rucaparib compare with competitors like olaparib?
Olaparib has broader prior approvals (including breast and ovarian cancers), a larger market share, and aggressive marketing strategies. Rucaparib’s niche benefits from specific indications and geographic presence.

2. What are the primary markets for rucaparib?
The US dominates with about 70% of sales; Europe accounts for about 20%, and Asia-Pacific for 10%, with growth prospects tied to regulatory approvals.

3. What are the main barriers to growth?
Pricing pressures, stiff competition, limited diagnostic infrastructure in emerging markets, and off-label restrictions.

4. What role does companion diagnostic testing play?
It increases the likelihood of targeted therapy, improving efficacy and operational efficiency, which can influence payer acceptance.

5. Are there any upcoming regulatory decisions that could impact the market?
Yes. Approvals for new indications, especially in prostate cancer in the US, Europe, and Asia, could significantly influence revenue trajectory.

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Sources

[1] Grand View Research, “PARP Inhibitors Market Size & Trends,” 2022.
[2] American Cancer Society, “Cancer Facts & Figures,” 2022.