RUBRACA Drug Patent Profile

Which patents cover Rubraca, 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	21
Drug Prices:	Drug price information for RUBRACA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RUBRACA
What excipients (inactive ingredients) are in RUBRACA?	RUBRACA excipients list
DailyMed Link:	RUBRACA at DailyMed

See drug prices for RUBRACA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RUBRACA

Constraining patent/regulatory exclusivity:

9,987,285

NDA:

209115

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 RUBRACA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Rhode Island Hospital	Phase 1/Phase 2
Brown University	Phase 1/Phase 2
Bayer	Phase 1/Phase 2

See all RUBRACA clinical trials

Pharmacology for RUBRACA

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

US Patents and Regulatory Information for RUBRACA

RUBRACA is protected by nineteen US patents.

This potential generic entry date is based on patent 9,987,285.

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	8,143,241
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	8,754,072		Y	Y
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	10,278,974		Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	10,130,636
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	9,861,638

Expired US Patents for RUBRACA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	6,495,541
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	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	209115-003	May 1, 2017	6,495,541
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016	7,531,530

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
Singapore	10201406805R	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
Denmark	2305221
Poland	1684736
Japan	2016216507	８−フルオロ−２−｛４−［（メチルアミノ）メチル］フェニル｝−１，３，４，５−テトラヒドロ−６Ｈ−アゼピノ［５，４，３−ｃｄ］インドール−６−オンの塩および多形体 (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)
Norway	2015008
European Patent Office	1140936	INHIBITEURS TRICYCLIQUES DE POLY(ADP-RIBOSE) POLYMERASES (TRICYCLIC INHIBITORS OF POLY(ADP-RIBOSE) POLYMERASES)

Supplementary Protection Certificates for RUBRACA

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
1633724	1590019-4	Sweden		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	596	Finland

RUBRACA Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is RUBRACA's Primary Indication and Mechanism of Action?

RUBRACA (rucaparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (as detected by an FDA-approved test) epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more prior lines of chemotherapy and whose cancer is associated with mutations in genes encoding homologous recombination repair (HRR) pathway proteins. It is also indicated for adult patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) metastatic castration-resistant prostate cancer (mCRPC) who have received at least one treatment with an androgen receptor-targeting agent and have no more than two prior chemotherapy regimens in the metastatic setting.

RUBRACA functions by inhibiting PARP enzymes, specifically PARP1, PARP2, and PARP3. PARP enzymes are critical for DNA repair, particularly single-strand break repair. In cancer cells with existing deficiencies in HRR pathways, such as BRCA mutations, the inhibition of PARP leads to an accumulation of DNA damage that these cells cannot effectively repair, ultimately causing cell death. This synthetic lethality approach targets cancer cells with specific genetic vulnerabilities.

What is RUBRACA's Current Market Position and Competitive Landscape?

RUBRACA, developed by Clovis Oncology, operates within the targeted therapy segment of the oncology market. Its primary competitors include other PARP inhibitors and drugs targeting HRR pathways.

Key competitors include:

• Olaparib (Lynparza): Developed by AstraZeneca and Merck, olaparib is approved for various indications, including ovarian, breast, prostate, and pancreatic cancers, with broader BRCA mutation coverage and indications across different lines of therapy.
• Niraparib (Zejula): Developed by GSK, niraparib is approved for ovarian cancer, demonstrating efficacy in both BRCA-mutated and HRD-positive patients, regardless of prior treatment lines in some settings.
• Talazoparib (Talzenna): Developed by Pfizer, talazoparib is approved for BRCA-mutated HER2-negative locally advanced or metastatic breast cancer and has a strong focus on germline BRCA mutations.

RUBRACA's market position is characterized by its specific indications, particularly in later lines of therapy for ovarian and prostate cancer, and its reliance on precise biomarker testing for patient selection. The evolving landscape of ovarian cancer treatment, with approvals for PARP inhibitors in first-line maintenance settings and combinations with other agents, has influenced market dynamics. Similarly, the expansion of PARP inhibitors into prostate cancer has intensified competition.

What are RUBRACA's Key Regulatory Approvals and Exclusivity Periods?

RUBRACA received its first U.S. Food and Drug Administration (FDA) approval on December 19, 2016, for the treatment of adult patients with deleterious BRCA-mutated advanced ovarian cancer who have been treated with two or more prior chemotherapy regimens. This initial approval was based on objective response rate and duration of response.

Subsequent U.S. FDA approvals include:

• June 5, 2017: Expansion of indication to include patients with deleterious or suspected deleterious germline BRCA mutations.
• April 6, 2020: Accelerated approval for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received at least one treatment with an androgen receptor-targeting agent and have no more than two prior chemotherapy regimens in the metastatic setting. This approval was based on objective response rate and duration of response. On February 20, 2023, this indication was converted to a full approval.

As of the latest available data, RUBRACA holds patent protection. The primary composition of matter patent for rucaparib is expected to expire around 2027 in the U.S. However, additional patents related to methods of use, formulations, and manufacturing processes may extend market exclusivity beyond this date, depending on patent challenges and litigation outcomes. Data exclusivity periods also apply following regulatory approval, providing additional protection against generic competition.

What are RUBRACA's Sales Performance and Financial Projections?

Clovis Oncology has reported the following net product revenues for RUBRACA:

Year	Net Product Revenue (USD Millions)
2021	$148.4
2022	$124.7
2023	$137.1

Source: Clovis Oncology SEC Filings (10-K and 10-Q reports).

The sales performance reflects market penetration within its approved indications and competitive pressures. Fluctuations in revenue can be attributed to factors including physician prescribing patterns, patient access, formulary exclusions, and competition from other targeted therapies.

Financial projections for RUBRACA are subject to ongoing market dynamics, including the uptake of newer therapies, potential label expansions, and the eventual impact of generic competition. Analysts' consensus estimates, which are proprietary and subject to change, generally project continued revenue generation through the mid-2020s, with a gradual decline anticipated as patent exclusivities wane and generic entrants emerge.

What are the Key Challenges and Opportunities for RUBRACA?

Challenges:

• Intensifying Competition: The PARP inhibitor class is crowded, with multiple established and emerging competitors offering broader indications, improved efficacy in certain patient populations, or combination strategies. This necessitates clear differentiation for RUBRACA.
• Biomarker Selectivity: While precise, the reliance on BRCA mutations and other HRR pathway alterations for eligibility requires robust diagnostic testing infrastructure and physician familiarity with biomarker identification.
• Reimbursement and Access: Navigating payer landscapes and securing broad reimbursement across different healthcare systems can be complex, impacting patient access and prescriber confidence.
• Clinical Trial Nuances: Evolving treatment paradigms in ovarian and prostate cancer, including earlier use of targeted agents and combination therapies, may shift the positioning of RUBRACA to later lines of therapy, potentially limiting its addressable market.
• Patent Expirations: The approaching expiration of key patents presents a significant challenge to sustained revenue generation, paving the way for generic competition.

Opportunities:

• Label Expansion: Investigating RUBRACA in new indications or patient populations, potentially in combination therapies, could expand its market reach. Research into other solid tumors with HRR deficiencies may offer future avenues.
• Geographic Market Penetration: Continued efforts to expand market access and reimbursement in international markets can drive incremental revenue growth.
• Real-World Evidence Generation: Publishing real-world data demonstrating RUBRACA's effectiveness and safety in routine clinical practice can reinforce its value proposition to physicians and payers.
• Combination Therapies: Exploring novel combinations of RUBRACA with other anticancer agents (e.g., immunotherapy, angiogenesis inhibitors) may enhance efficacy and create new treatment paradigms, particularly in difficult-to-treat settings.
• Patient Support Programs: Robust patient assistance programs can help mitigate access barriers and ensure eligible patients receive treatment, thereby supporting sales volumes.

What is the Impact of Generic Competition on RUBRACA's Future Revenue?

The U.S. patent expiration for RUBRACA's composition of matter is anticipated around 2027. Upon patent expiry, generic manufacturers will likely seek to introduce their own versions of rucaparib, leading to a significant and rapid decline in RUBRACA's net product revenue. This phenomenon is standard for branded pharmaceuticals.

The timing and extent of this revenue erosion will depend on:

• Number of Generic Entrants: Multiple generic competitors entering the market simultaneously will accelerate price erosion.
• Pricing Strategies of Generic Manufacturers: Aggressive pricing by generics will directly impact RUBRACA's market share and revenue.
• Interchangeability and Bioequivalence: Generic versions must demonstrate bioequivalence to RUBRACA. Regulatory approval for generics is a prerequisite for market entry.
• Physician and Payer Prescribing Habits: Prescribers and payers often shift towards lower-cost generic options once they become available, especially for therapies in later lines of treatment.

Clovis Oncology's strategy to mitigate this impact typically involves maximizing sales during the remaining exclusivity period, potentially exploring lifecycle management strategies for the drug, or focusing R&D efforts on pipeline assets.

Key Takeaways

• RUBRACA (rucaparib) is a PARP inhibitor targeting specific DNA repair deficiencies, primarily in ovarian and prostate cancers.
• The drug faces strong competition from other PARP inhibitors such as olaparib, niraparib, and talazoparib.
• RUBRACA's market position is defined by its approved indications, particularly in later lines of therapy, and its reliance on biomarker testing.
• Key regulatory approvals in the U.S. have been secured, with full approval for prostate cancer achieved in 2023.
• RUBRACA's net product revenues have fluctuated, with $137.1 million reported in 2023.
• Challenges include intensifying competition, reimbursement hurdles, and the approaching expiration of key patents.
• Opportunities lie in potential label expansions, geographic penetration, and the development of combination therapies.
• Generic competition is projected to significantly impact RUBRACA's revenue trajectory following its patent expiry around 2027.

Frequently Asked Questions

1. When is the patent for RUBRACA expected to expire in the United States? The primary composition of matter patent for rucaparib is projected to expire around 2027 in the U.S.

2. What are the main indications for which RUBRACA is approved? RUBRACA is approved for adult patients with BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer who have undergone prior chemotherapy, and for adult patients with BRCA-mutated metastatic castration-resistant prostate cancer who have received prior androgen receptor-targeting agent treatment.

3. Who are the primary competitors to RUBRACA in the PARP inhibitor market? Key competitors include olaparib (Lynparza), niraparib (Zejula), and talazoparib (Talzenna).

4. How has RUBRACA's net product revenue performed in recent years? Net product revenues were $148.4 million in 2021, $124.7 million in 2022, and $137.1 million in 2023.

5. What is the mechanism of action for RUBRACA? RUBRACA inhibits PARP enzymes, leading to DNA damage accumulation and cell death in cancer cells with HRR pathway deficiencies, such as BRCA mutations.

Citations

[1] U.S. Food & Drug Administration. (2016, December 19). FDA approves Rubraca (rucaparib) for patients with advanced ovarian cancer. [Press Release]. [2] U.S. Food & Drug Administration. (2020, April 6). FDA approves rucaparib for treatment of BRCA-mutated metastatic castration-resistant prostate cancer. [Press Release]. [3] U.S. Food & Drug Administration. (2023, February 20). FDA approves rucaparib for treatment of metastatic castration-resistant prostate cancer. [Press Release]. [4] Clovis Oncology. (2023). Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Form 10-K for the fiscal year ended December 31, 2022. U.S. Securities and Exchange Commission. [5] Clovis Oncology. (2023). Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Form 10-Q for the quarterly period ended September 30, 2023. U.S. Securities and Exchange Commission. [6] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from USPTO website. (Specific patent numbers would be required for precise expiry dates and are subject to ongoing litigation and analysis).