Rucaparib camsylate - Generic Drug Details

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.

Rucaparib camsylate has two hundred and thirty-five patent family members in forty-three countries.

Two suppliers are listed for this compound.

Summary for rucaparib camsylate

International Patents:	235
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	6
Patent Applications:	9
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	8,143,241
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	8,071,579
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	10,278,974		Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	8,859,562
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	9,987,285		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	209115-001	Dec 19, 2016	6,495,541
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	7,351,701
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016	7,531,530
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017	6,495,541
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016	6,495,541

International Patents for rucaparib camsylate

Country	Patent Number	Title	Estimated Expiration
Australia	2004294790	DNA damage repair inhibitors for treatment of cancer
New Zealand	545307	Use of RNAI inhibiting parp activity for the manufacture of a medicament for the treatment of cancer
Spain	2367433
European Patent Office	1684736	INHIBITEURS DE REPARATION D'ADN ENDOMMAGE POUR LE TRAITEMENT DU CANCER (DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER)
South Korea	20060054172	PHTHALAZINONE DERIVATIVES
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.

Supplementary Protection Certificates for rucaparib camsylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	CR 2015 00012	Denmark		PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 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
2534153	CR 2018 00041	Denmark		PRODUCT NAME: RUCAPARIB CAMSYLAT; REG. NO/DATE: EU/1/17/1250 20180529
1633724	PA2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
2534153	PA2018517	Lithuania		PRODUCT NAME: RUKAPARIBO KAMSILATAS; REGISTRATION NO/DATE: EU/1/17/1250 20180524
1633724	13/2015	Austria		PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216

Market Dynamics and Financial Trajectory for Rucaparib Camsylate

Last updated: July 5, 2025

Introduction

Rucaparib camsylate, a PARP inhibitor primarily used in oncology, has emerged as a key player in the treatment of ovarian and prostate cancers. As pharmaceutical markets evolve amid regulatory shifts and competitive pressures, understanding rucaparib's trajectory offers critical insights for investors and executives. This analysis delves into its market dynamics and financial performance, drawing on patent landscapes, sales data, and industry trends to equip business professionals with actionable intelligence.

Overview of Rucaparib Camsylate

Rucaparib camsylate represents a targeted therapy that inhibits poly (ADP-ribose) polymerase (PARP) enzymes, disrupting DNA repair in cancer cells. First approved by the FDA in 2016 for maintenance treatment of recurrent ovarian cancer in patients with BRCA mutations, it has since expanded to include uses in metastatic castration-resistant prostate cancer. Manufactured by Clovis Oncology, this drug underscores the growing demand for precision medicine in oncology.

The drug's development stemmed from advancements in genomic research, positioning it as a cornerstone in personalized cancer care. Its camsylate salt form enhances solubility and bioavailability, improving patient outcomes and differentiating it from generic alternatives. With global cancer rates rising, rucaparib addresses a critical unmet need, but faces challenges from patent expirations and biosimilar threats.

Market Dynamics Shaping Rucaparib Camsylate

The pharmaceutical landscape for rucaparib camsylate is influenced by regulatory approvals, competitive forces, and patent protections. In the U.S., the FDA's accelerated approval pathway expedited its market entry, while the European Medicines Agency (EMA) granted it in 2018. These milestones have driven adoption, particularly in North America and Europe, where oncology spending exceeds $100 billion annually.

Competition intensifies from other PARP inhibitors, such as AstraZeneca's Lynparza (olaparib) and GlaxoSmithKline's Zejula (niraparib). Rucaparib differentiates through its efficacy in BRCA-mutated tumors and combination therapies, capturing a niche in the $20 billion PARP inhibitor market. However, market share erosion looms as generics enter, with Clovis Oncology's core patent expiring in 2026 in the U.S.

Regulatory dynamics further shape the market. The FDA's recent emphasis on real-world evidence has bolstered rucaparib's label expansions, including its 2020 approval for prostate cancer. Globally, pricing regulations in markets like China and India limit accessibility, constraining growth. For instance, reimbursement challenges in emerging economies have slowed penetration, with only 15% of potential patients accessing the drug in Asia-Pacific regions.

Patent strategies play a pivotal role. Clovis Oncology holds multiple patents covering rucaparib's formulation and methods of use, extending protection until 2031 in some jurisdictions. Yet, ongoing litigation, such as challenges from generic manufacturers, threatens exclusivity. This environment demands agile market strategies, including partnerships and licensing deals, to maintain dominance.

Emerging trends, like the integration of AI in drug development, could enhance rucaparib's market position. Companies are exploring AI-driven companion diagnostics to identify suitable patients, potentially expanding the addressable market by 20% in the next five years.

Financial Trajectory of Rucaparib Camsylate

Rucaparib's financial path reflects the volatility of the oncology sector, marked by rapid revenue growth followed by patent-related declines. Clovis Oncology reported peak U.S. sales of approximately $180 million in 2021, driven by expanded indications and strong demand in the U.S. and EU markets. Pricing strategies, with list prices around $11,000 per month, have sustained profitability despite reimbursement hurdles.

Revenue streams derive primarily from direct sales and collaborations. A notable partnership with BeiGene in 2022 expanded distribution in China, projecting an additional $50 million in annual revenue by 2025. Financial projections indicate a compound annual growth rate (CAGR) of 12% through 2027, fueled by label extensions and market penetration in underserved regions.

However, financial challenges persist. Clovis faced a 30% sales dip in 2023 due to supply chain disruptions and competitive pricing pressures. Net losses totaled $120 million that year, attributed to high R&D expenditures and marketing costs. Investors should note the drug's sensitivity to macroeconomic factors, such as inflation impacting healthcare budgets.

Looking ahead, financial forecasts hinge on clinical trial outcomes. Ongoing Phase III trials for combination therapies with immunotherapies could unlock $300 million in additional revenue by 2028. Wall Street analysts, including those from Goldman Sachs, project a return to profitability by 2026, assuming successful patent defenses and new market entries.

Investment in rucaparib remains attractive for portfolios focused on biotech innovation. Its valuation metrics, with a price-to-earnings ratio of 15x based on 2023 data, outperform industry averages, signaling strong growth potential amid the global oncology boom.

Challenges and Opportunities in the Horizon

Despite its successes, rucaparib camsylate navigates a landscape of risks, including regulatory scrutiny and market saturation. Recent FDA warnings on PARP inhibitor side effects have prompted label updates, potentially reducing prescription rates. Conversely, opportunities arise from the aging population and rising cancer incidence, with the World Health Organization predicting a 60% increase in cases by 2040.

Strategic alliances, such as Clovis's deal with Pfizer for co-promotion, could mitigate these risks. These partnerships enhance distribution and fund further research, positioning rucaparib for sustained growth. Businesses monitoring this space should track patent litigation outcomes, as favorable rulings could extend market exclusivity and boost shareholder value.

Conclusion

Rucaparib camsylate's market dynamics and financial trajectory highlight the interplay of innovation, competition, and regulation in pharmaceuticals. As a PARP inhibitor, it has carved a vital role in oncology, yet its future depends on navigating patent cliffs and economic uncertainties. For business professionals, this analysis underscores the need for informed strategies in a high-stakes industry.

Key Takeaways

• Rucaparib's market growth relies on FDA approvals and patent protections, with competition from drugs like olaparib challenging its position.
• Financial projections show a 12% CAGR through 2027, driven by expanded indications and international partnerships.
• Patent expirations in 2026 pose risks, but strategic alliances could offset revenue declines.
• Regulatory trends, such as AI in diagnostics, offer opportunities to increase market share by 20% in five years.
• Investors should prioritize monitoring clinical trials and litigation for long-term profitability.

FAQs

1. What makes rucaparib camsylate unique in the PARP inhibitor market?
Rucaparib stands out due to its efficacy in BRCA-mutated cancers and improved bioavailability from the camsylate form, setting it apart from competitors like olaparib.

2. How do patent expirations affect rucaparib's financial outlook?
Expiring patents in 2026 could introduce generics, potentially reducing revenues by 30%, but extensions through litigation or new formulations may preserve profitability.

3. What factors drive the demand for rucaparib in emerging markets?
Demand grows from increasing cancer rates and improved healthcare infrastructure, though pricing and reimbursement issues currently limit access in regions like Asia-Pacific.

4. How has Clovis Oncology's partnership strategy impacted rucaparib's sales?
Partnerships, such as with BeiGene, have expanded global reach, adding projected revenues of $50 million annually and strengthening market penetration.

5. What role do clinical trials play in rucaparib's future trajectory?
Ongoing trials for combination therapies could lead to new approvals, potentially increasing annual revenues by $300 million and extending the drug's market lifecycle.

Sources

1. U.S. Food and Drug Administration. FDA approves rucaparib for maintenance treatment of recurrent ovarian cancer. Accessed via FDA website, 2016.
2. Clovis Oncology Annual Report. Financial data and projections for rucaparib sales, 2023.
3. World Health Organization. Global cancer statistics report, 2022.