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 and one FDA Regulatory Exclusivity.

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
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
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			Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No			Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No

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
Japan	5745283
Russian Federation	2017109139	ТАБЛЕТКИ, СОДЕРЖАЩИЕ БОЛЬШУЮ ДОЗУ РУКАПАРИБА
Lithuania	4936	TRICIKLIAI POLI(ADP-RIBOZĖS) POLIMERAZIŲ INHIBITORIAI (TRICYCLIC INHIBITORS OF POLY(ADP-RIBOSE) POLYMERASES)
Portugal	3150610
Croatia	P20010573	TRICIKLIČKI INHIBITORI POLI(ADP-RIBOZA) POLIMERAZA (TRICYCLIC INHIBITORS OF POLY(ADP-RIBOSE) POLYMERASES)
Australia	2019272064	High dosage strength tablets of rucaparib
Japan	2009079056	PHTHALAZINONE DERIVATIVE

Supplementary Protection Certificates for RUBRACA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	C20150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
2534153	48/2018	Austria		PRODUCT NAME: RUCAPARIBCAMSYLAT; REGISTRATION NO/DATE: EU/1/17/1250 (MITTEILUNG) 20180529
2534153	C20180033 00273	Estonia		PRODUCT NAME: RUKAPARIIB;REG NO/DATE: EU/1/17/1250 29.05.2018
2534153	CR 2018 00041	Denmark		PRODUCT NAME: RUCAPARIB CAMSYLAT; REG. NO/DATE: EU/1/17/1250 20180529
2534153	PA2018517,C2534153	Lithuania		PRODUCT NAME: RUKAPARIBO KAMSILATAS; REGISTRATION NO/DATE: EU/1/17/1250 20180524
1633724	213 50005-2015	Slovakia		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
1633724	2015/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216

RUBRACA (rucaparib) Investment Scenario and Fundamentals Analysis

Last updated: April 25, 2026

What is RUBRACA and what is its market position?

RUBRACA is the brand name for rucaparib, an oral inhibitor of poly(ADP-ribose) polymerase (PARP). It is used in oncology, primarily in ovarian cancer and other BRCA-mutated or homologous recombination deficiency (HRD)-driven settings, where synthetic lethality with PARP inhibition is clinically relevant. In the US, rucaparib is marketed by Clovis Oncology (now part of Kite, acquired by Gilead; ownership and commercial execution sit within Gilead’s oncology franchise post-transaction).

Strategic demand driver: PARP inhibitors compete across overlapping biomarker-defined populations (BRCA mutations and HRD status) and across treatment lines. RUBRACA’s commercial durability depends on: (1) label coverage versus competitors, (2) sequencing after prior PARP exposure, (3) penetration in maintenance settings, and (4) overall market share among PARP inhibitors.

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What are the core clinical and regulatory fundamentals behind RUBRACA?

Rucaparib’s value proposition historically rests on demonstrated efficacy in germline or somatic BRCA-mutated tumors and in broader HRD-enriched subsets, with activity that has supported multiple label expansions over time. Commercial relevance is tied to how regulators define eligible populations and how clinicians use those definitions in real-world sequencing.

Key fundamental lens for investors: PARP inhibitors face intensifying competition and constrained populations after broader first-line adoption. RUBRACA’s fundamentals therefore hinge on whether its labeled niches (and supporting biomarker criteria) translate into persistent prescribing in community and academic practice.

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How does RUBRACA price and reimbursement pressure it versus PARP peers?

Rucaparib operates in a class where net prices and rebate structures are shaped by: (1) manufacturer contracting, (2) payer formulary decisions, and (3) site-of-care economics for oral oncology agents.

Competitive pressure points

• Class-level gross-to-net compression: common across oral oncology as payers push for value-based contracting and patient access discounts.
• Sequencing logic: payers increasingly scrutinize “post-PARP” scenarios since progression after prior PARP inhibition can affect expected response.
• Bio-marker testing requirements: costs and access pathways for BRCA/HRD testing can affect prescribing speed and realized demand.

Investment implication: RUBRACA’s revenue sensitivity is higher in periods where payers tighten access for later-line or post-exposure treatment, even if label coverage remains unchanged.

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Who are RUBRACA’s competitive set and what matters most to share?

RUBRACA competes in the PARP inhibitor segment with other agents including olaparib, niraparib, and talazoparib, plus ongoing efforts to differentiate via biomarker strategies, line-of-therapy fit, and combinations.

Primary levers that decide PARP inhibitor share

• Line-of-therapy adoption: first-line maintenance and subsequent progression markets behave differently than later-line single-agent use.
• Biomarker strength: BRCA-mutated versus HRD-negative or low-HRD populations shift expected benefit.
• Treatment duration expectations: maintenance strategies can yield longer exposure but also increase payer scrutiny.
• Tolerability and discontinuation rates: adherence affects realized dose intensity and total drug utilization.

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What is the demand outlook by near-term adoption dynamics?

Near-term commercialization for RUBRACA is dominated by PARP class behavior:

1. Ongoing maintenance uptake in ovarian cancer continues to anchor a base demand pool for PARP inhibitors, but share rotates among branded players.
2. Post-first-line sequencing becomes the battleground: once patients have received a PARP inhibitor, subsequent responses matter more than label wording.
3. Combination strategies (where they gain traction) can create incremental demand if they shift standard-of-care earlier or broaden eligibility.

Investment implication: The base case typically treats RUBRACA as a “share-driven” asset rather than a “label expansion” asset unless new indications or stronger comparative positioning emerge.

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What is the valuation setup investors should model (revenue and risk map)?

A fundamentals model for RUBRACA should map revenue to PARP market mechanics:

Key revenue drivers to model

Driver	What moves it	Why it matters
Share in PARP-treated ovarian populations	Formulary access and guideline uptake	Oral oncology share is primarily payer and clinician workflow-driven
Line-of-therapy mix	Maintenance versus subsequent lines	Post-exposure periods can compress expected benefit and payer willingness
Patient persistence	Side-effect management and dose reductions	PARP utilization is duration-sensitive
Biomarker eligibility throughput	Testing access for BRCA/HRD	Slower testing reduces start rates and delays therapy initiation

Key downside risks

• PARP sequencing limitations: reduced response post prior PARP inhibitor can impact adoption.
• Intensifying price pressure: gross-to-net compression as payers normalize contracting.
• Competitive label perception: even without direct label changes, clinician preference can shift toward agents viewed as more consistent in specific biomarker strata.

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What corporate and pipeline context supports or constrains RUBRACA?

For an asset like RUBRACA, corporate context matters because PARP demand is influenced by:

• how aggressively the company invests in real-world evidence generation,
• whether combinations are pursued in the most commercially attractive settings,
• and whether the broader oncology portfolio drives payer confidence.

A second-order constraint is that PARP inhibitor portfolios increasingly face trial readouts tied to earlier lines and combinations, which can reorder standard-of-care and shift market share.

Investment implication: RUBRACA’s best-case scenario is continued market maintenance plus incremental uptake via evidence generation that supports use in defined subgroups. Bear cases are dominated by substitution to peers and tighter access for later-line or post-PARP therapy.

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What milestones and catalysts are most relevant to underwriting RUBRACA?

Underwriting should prioritize clinical and regulatory catalysts that change prescribing behavior:

Catalyst buckets

• Regulatory label changes (new indications or expanded biomarker-defined populations)
• Practice-setting evidence (real-world persistence, comparative outcomes in sequencing)
• Competitive readouts (other PARP inhibitors or PARP combinations that shift clinician preference)

Investment implication: For mature PARP assets, incremental catalysts often come more from evidence and sequencing shifts than from headline efficacy announcements.

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How should investors evaluate financial durability in a mature PARP franchise?

For mature oral oncology brands, durability hinges on:

• maintaining formulary positions,
• limiting leakage as patients transition to other PARP inhibitors,
• and ensuring continued patient persistence.

Practical underwriting stance

• Model a base level of PARP demand growth tied to ovarian cancer incidence and evolving maintenance adoption.
• Apply share assumptions under competitive substitution risks.
• Use persistence and discontinuation as the principal sensitivity for utilization-based forecasting.

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Key Takeaways

• RUBRACA (rucaparib) is a mature PARP inhibitor whose value depends more on share, sequencing adoption, and persistence than on broad label growth.
• Competitive dynamics among PARP peers determine near-term revenue stability, especially after patients receive prior PARP therapy.
• Net price and payer access drive realized demand; oral oncology contracting and formulary positioning can materially affect uptake.
• The most material underwriting variables are line-of-therapy mix, biomarker eligibility throughput, and treatment duration/persistence.

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FAQs

1. Is RUBRACA primarily an ovarian cancer drug?
   Yes. RUBRACA’s commercial use is anchored in oncology indications centered on ovarian cancer populations defined by BRCA status and related HRD biomarkers.

2. What most impacts RUBRACA revenue: volume or price?
   For mature PARP assets, both matter, but share and sequencing-driven volume and gross-to-net pressure typically dominate near-term performance.

3. How does prior PARP exposure affect RUBRACA use?
   Prior PARP exposure can reduce expected benefit and tends to tighten adoption in later-line settings, shaping payer coverage and clinician sequencing choices.

4. What biomarkers are central to RUBRACA prescribing?
   BRCA-mutated status and broader HRD frameworks are central to eligibility and clinical selection for PARP inhibitor therapy.

5. What catalysts should investors watch for?
   The most market-moving events are label expansions, evidence that improves positioning in sequencing, and trial outcomes that shift standard-of-care toward or away from rucaparib.

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References

[1] U.S. Food and Drug Administration. FDA label information for RUBRACA (rucaparib). FDA.
[2] National Cancer Institute. PARP inhibitors (class overview) and ovarian cancer treatment context. NCI.
[3] EMA. RUBRACA (rucaparib) EPAR. European Medicines Agency.
[4] ClinicalTrials.gov. Rucaparib (PARP inhibition) clinical trial listings and study results. U.S. National Library of Medicine.