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

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
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	209115-002	Dec 19, 2016		RX	Yes	Yes	10,130,636
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	9,861,638
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	9,861,638
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	8,859,562
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
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	10,278,974		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	209115-003	May 1, 2017	6,495,541
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016	7,531,530
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016	6,495,541
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
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017	7,351,701
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016	7,351,701

International Patents for RUCAPARIB CAMSYLATE

Country	Patent Number	Title	Estimated Expiration
Denmark	1660095
Brazil	112012019050
Colombia	5650256	DERIVADOS DE FTALAZINONA
Poland	2305221
Norway	334610
European Patent Office	3150610
Mexico	PA06006120	INHIBIDORES DE REPARACION DE DANO DE ACIDO DESOXIRRIBONUCLEICO PARA TRATAMIENTO DE CANCER. (DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER.)

Supplementary Protection Certificates for RUCAPARIB CAMSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	2015/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
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
2534153	C201830056	Spain		PRODUCT NAME: CAMSILATO DE RUCAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1250; DATE OF AUTHORISATION: 20180524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1250; DATE OF FIRST AUTHORISATION IN EEA: 20180524
2534153	1890042-3	Sweden		PRODUCT NAME: RUCAPARIB CAMSYLATE; REG. NO/DATE: EU/1/17/1250 20180529
2534153	2018039	Norway		PRODUCT NAME: RUKAPARIBKAMSYLAT; REG. NO/DATE: EU/1/17/1250 20180531
2534153	2018C/044	Belgium		PRODUCT NAME: RUCAPARIB-CAMSYLAAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1250 20180529
2534153	300958	Netherlands		PRODUCT NAME: RUCAPARIB CAMSYLAAT; REGISTRATION NO/DATE: EU/1/17/1250 20180529

RUCAPARIB CAMSYLATE Market Dynamics and Financial Trajectory

Last updated: April 29, 2026

What is Rucaparib camsylate’s current market position?

Rucaparib camsylate is the salt form of rucaparib (an oral PARP inhibitor). In market practice, commercial performance is driven by how clinicians and payers use rucaparib across ovarian cancer and related indications, the pace of line-of-therapy movement, and competitive substitution from other PARP inhibitors plus trial-driven evidence that expands or limits patient populations.

Financially, the near-term trajectory for the molecule category is shaped by three recurring forces: (1) indication mix and durability of benefit, (2) payer access and price pressure as multiple PARP inhibitors compete, and (3) pipeline adjacency (earlier-line use, combination regimens, and biomarker stratification) that can either extend demand or re-segment it.

How do demand drivers work for rucaparib in real-market terms?

Demand for rucaparib (and by extension rucaparib camsylate) is determined by the intersection of prescribing evidence and market access. The key dynamics are:

Indication mix and treatment-line positioning

Rucaparib is used in ovarian cancer settings where PARP inhibition is standard of care. Market uptake depends on:

• Fit to evidence-based criteria (histology, biomarker status, treatment history)
• Movement across lines of therapy as guidelines evolve
• Shifts in clinical preference as trial results expand combination or maintenance options

Biomarker and sequencing effects

PARP inhibitors are increasingly stratified by biomarkers and prior exposure. Commercial impact comes from:

• Real-world test ordering patterns (BRCA, HRD and related markers)
• Switching behavior after progression on a first PARP inhibitor
• How payers restrict coverage by line of therapy and prior treatments

Competitive substitution pressure

Rucaparib faces ongoing substitution from other PARP inhibitors. The practical effects are:

• Formulary tiering and prior authorization standards
• Price concessions or managed entry agreements that redistribute share among the class
• Prescriber inertia versus evidence-based switching, especially in maintenance and post-progression settings

What do the financial trajectories typically look like for this drug class?

The pharmaceutical PARP inhibitor category tends to show a recognizable financial shape when patents approach major expirations, label expansions occur, and competition intensifies. For rucaparib-based products, the trajectory is usually governed by:

Revenue growth and then normalization phases

• Early expansion: uptake in established indications as adoption spreads beyond initial launch centers
• Mid-cycle stabilization: share becomes sensitive to payer edits, copay dynamics, and competition
• Late-cycle volatility: combination readouts, new line-of-therapy uses, and negative trial outcomes can swing prescribing

Margin and operating profit sensitivity

PARP inhibitor economics are sensitive to:

• Sales growth rate versus fixed cost base (commercial, clinical, regulatory)
• Net-to-gross changes driven by rebates, discounts, and specialty pharmacy contracting
• Costs from life-cycle management (new formulations, additional registrational work)

How does the salt form (camsylate) influence commercialization?

Salt forms can matter for manufacturability, stability, and dosing attributes, but class demand is still driven by the active moiety (rucaparib). For the market and financial trajectory:

• Clinical differentiation from the salt form is typically limited; prescribers treat it as rucaparib
• Commercial differentiation comes more from labeling, supply reliability, and price/access than from salt chemistry alone

In practice, the camsylate form tends to support supply chain execution and formulation logistics rather than creating a distinct market segment.

What pricing and payer dynamics typically determine rucaparib’s uptake?

For PARP inhibitors, net price is not the headline list price; it is the outcome of payer contracting and patient cost-sharing design. The main determinants include:

• Step therapy and prior authorization requirements
• Coverage restrictions tied to line of therapy, biomarker positivity, and prior PARP inhibitor exposure
• Specialty pharmacy network rules and drug acquisition benchmarks
• Patient assistance program design that changes net patient cost and affects conversion rates

This is where competition manifests: when multiple PARP inhibitors are available, payers use coverage criteria to direct utilization to preferred products, shifting share and revenue trajectory across the class.

What competitive landscape pressure matters most to financial outcomes?

Rucaparib’s financial path is shaped by how other PARP inhibitors perform on:

• Formulary placement (preferred vs non-preferred)
• Comparative efficacy positioning in relevant subgroups
• Real-world tolerability and adherence profiles that affect persistence and re-treatment rates

The most revenue-relevant competition is not only efficacy but also access. Even with comparable clinical performance, payer steering and patient access can determine which product captures incremental patients.

What operational factors influence sales scaling and stability?

Rucaparib-based products are typically sensitive to supply stability and manufacturing consistency. Operational drivers affecting financial trajectory include:

• Manufacturing scale readiness to avoid distribution constraints
• Batch release timelines and quality system maturity
• Product continuity across dose strength and packaging formats

A supply interruption can translate directly into lost prescriptions, while stable supply supports persistence and refill behavior.

What does the “financial trajectory” mean in investment terms?

For investors and finance teams, a credible trajectory for rucaparib camsylate should be interpreted as:

• Unit demand growth (new starts, persistence, and switches) driven by label positioning and payer access
• Net sales sensitivity to rebate and discount structure
• Operating leverage from incremental sales against fixed commercial and development spend

In PARP inhibitors, the dominant question is whether the company can keep share as formularies tighten and competitors reinforce preferred positioning.

Market dynamics snapshot (practical drivers)

Dimension	What moves demand	Typical commercial effect
Indication breadth	Expands eligible populations	Supports new starts and maintenance duration
Sequencing rules	Prior PARP exposure limits coverage	Reduces addressable patient pool
Payer policy	Prior authorization and step edits	Shifts share within class
Competitive placement	Preferred formulary tiering	Compresses net price and net-to-gross
Safety and persistence	Tolerability influences adherence	Impacts duration and refill rates

Financial trajectory: scenario framework for rucaparib camsylate

Because the molecule’s financial profile is mostly determined by PARP class behavior and market access, outcomes usually fall into three patterns:

Bull case pattern

• Label or guideline shifts support earlier or broader use
• Payer policies stay permissive relative to peers
• Persistence improves and switching away from rucaparib slows

Net effect: higher unit demand plus relatively stable net pricing.

Base case pattern

• Demand continues but new patient conversion slows as competitors entrench preferred status
• Net pricing declines through normal contracting cycles
• Share stabilizes but growth moderates

Net effect: sales growth becomes slower and more margin-sensitive.

Bear case pattern

• Coverage restrictions tighten for key biomarker or line-of-therapy segments
• Competition expands preferred formulary placement
• Adherence/persistence weakens due to real-world tolerability or dosing constraints

Net effect: net-to-gross pressure and declining share lead to revenue contraction or flat performance.

Where does this leave rucaparib camsylate in 2026-cycle dynamics?

The most business-relevant conclusion is that rucaparib camsylate’s financial trajectory is not primarily determined by salt-form marketing but by how the rucaparib franchise competes within the PARP inhibitor landscape through:

• payer steering,
• line-of-therapy eligibility,
• and persistence.

Those factors govern whether incremental patients are won or ceded to competitors and whether net pricing holds or erodes.

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Key Takeaways

• Rucaparib camsylate tracks the rucaparib franchise market performance, which is dominated by PARP inhibitor payer steering, sequencing restrictions, and line-of-therapy eligibility.
• Financial trajectory is primarily driven by net-to-gross and share dynamics within the PARP class, not by the salt form itself.
• Competitive placement and persistence are the two variables most likely to swing unit demand and margin in-year.

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FAQs

1. Is rucaparib camsylate marketed as a distinct drug or as rucaparib?
   It is commercially treated as rucaparib based on the active moiety, with the salt form mainly supporting formulation and supply.

2. What drives rucaparib revenue more: new patient starts or persistence?
   Both matter, but persistence and payer coverage in maintenance and post-progression settings often determine whether demand sustains after initial adoption.

3. How does competition within PARP inhibitors typically affect pricing?
   Competition tends to compress net pricing through rebates, contracting leverage, and formulary tiering that shifts utilization toward preferred products.

4. Why do sequencing and biomarker policies matter to financial outcomes?
   They define which patients are eligible under reimbursement rules, shrinking or expanding the addressable population and influencing share capture.

5. What is the most common operational risk for PARP inhibitor launches and scaling?
   Manufacturing and supply continuity; interruptions can reduce prescriptions and refill persistence even when clinical demand exists.

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References

[1] U.S. Food and Drug Administration. Drug Approval Package for rucaparib-containing products (label and approval documentation). FDA.
[2] European Medicines Agency. Assessment history and EPAR documentation for rucaparib (marketing authorization and label). EMA.
[3] National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Ovarian Cancer (PARP inhibitor recommendations and sequencing updates). NCCN.
[4] Published clinical trial and guideline literature supporting rucaparib use in ovarian cancer and related indications (comparative PARP inhibitor positioning).