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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 eleven patents protecting this drug.

This drug has two hundred and thirty-four patent family members in forty-three countries.

The generic ingredient in RUBRACA is rucaparib camsylate. Two suppliers are 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 four 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:	234
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
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
The Miriam Hospital	Phase 1/Phase 2
Rhode Island Hospital	Phase 1/Phase 2
Brown University	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 twenty-five US patents and one FDA Regulatory Exclusivity.

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	209115-003	May 1, 2017		RX	Yes	No	9,861,638
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	10,278,974		Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	9,987,285		Y
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	209115-003	May 1, 2017	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	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
Lithuania	2534153
Japan	2007533601
Singapore	150548	DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER
Japan	4093448

Supplementary Protection Certificates for RUBRACA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	S1500012	Hungary		PRODUCT NAME: OLAPARIB
2534153	1890042-3	Sweden		PRODUCT NAME: RUCAPARIB CAMSYLATE; REG. NO/DATE: EU/1/17/1250 20180529
2534153	48/2018	Austria		PRODUCT NAME: RUCAPARIBCAMSYLAT; REGISTRATION NO/DATE: EU/1/17/1250 (MITTEILUNG) 20180529
2534153	PA2018517	Lithuania		PRODUCT NAME: RUKAPARIBO KAMSILATAS; REGISTRATION NO/DATE: EU/1/17/1250 20180524

RUBRACA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: RUBRACA

Introduction

RUBRACA, developed by Clovis Oncology, is an oral, small-molecule inhibitor of PARP1, PARP2, and PARP3, primarily used in the treatment of ovarian cancer and other tumor types. Since its approval in December 2016, the drug has faced significant challenges in the competitive PARP inhibitor market.

Market Positioning of RUBRACA

RUBRACA was the second PARP inhibitor to enter the market, following AstraZeneca's Lynparza (olaparib). Despite this, it has struggled to gain substantial market share. Lynparza, the market leader, generated $297 million in sales in 2017, while Zejula (niraparib) from Tesaro Inc. brought in $109 million in its first nine months on the market. In contrast, RUBRACA's full-year sales were $55.5 million in 2017, with an additional $14 million in free drug product provided through a patient assistance program[1].

Competitive Landscape

The PARP inhibitor market is highly competitive, with multiple players vying for dominance. RUBRACA faces stiff competition from Lynparza and Zejula, both of which have expanded their indications beyond ovarian cancer. For instance, Lynparza has been approved for breast cancer, and Zejula is being tested in combination with other therapies for bladder cancer[1].

Regulatory Challenges

RUBRACA's approval in Europe is still pending, although it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in 2018. The company plans to submit a variation of its marketing authorization to gain approval for the second-line maintenance setting, which could be approved as soon as six months after the initial approval[1].

Financial Performance

The financial performance of RUBRACA has been inconsistent and has trended downward over the past two years. In 2022, Clovis Oncology reported a 13% year-over-year decrease in RUBRACA revenues. The company's operating expenses, including research and development, selling, general, and administrative costs, have been high, leading to significant operating losses. For example, in 2022, the company reported an operating loss of $153.976 million and a net loss of $187.642 million[2].

Cash Flow and Liquidity Issues

Clovis Oncology faces significant liquidity issues, with the company's cash and cash equivalents insufficient to maintain operations beyond January 2023. The company has relied heavily on debt and equity financings to fund its operations but has been unable to access the equity capital markets due to unfavorable market conditions and a low stock price. This has led to discussions about potential bankruptcy filing to preserve the value of the business and assets[2].

Market Forecast and Analysis

Despite the current challenges, market forecasts suggest that RUBRACA could still play a significant role in the treatment of ovarian cancer and other tumor types. A report by DelveInsight provides a detailed market assessment of RUBRACA for ovarian cancer in seven major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The report forecasts sales data from 2024 to 2032 and includes insights into the mechanism of action, dosage, and administration, as well as regulatory milestones and developmental activities[4].

Clinical Trials and Development

RUBRACA is being developed for multiple indications, including prostate and bladder cancer. Major data from the prostate cancer studies are expected to be presented at the European Society for Medical Oncology conference. Additionally, RUBRACA is being explored as a combination therapy with Bristol-Myers Squibb's PD-1 inhibitor Opdivo (nivolumab) for ovarian, breast, and prostate cancers[1].

Impact of Regulatory Framework

The regulatory landscape has significantly impacted RUBRACA's commercial potential. The approval of other PARP inhibitors for first-line maintenance treatment has reduced the available patient population for third-line treatment with RUBRACA. Physicians prefer treatments that do not require diagnostic testing, which has further limited RUBRACA's market share[1].

Analyst Insights

Analysts have noted that RUBRACA's approvals have been slower compared to its competitors. Evercore ISI analyst Steven Breazzano pointed out that most ovarian cancer PARP inhibitor approvals have come early, which has put RUBRACA at a disadvantage[1].

Conclusion

RUBRACA's market dynamics are characterized by intense competition, regulatory challenges, and financial struggles. Despite its potential in treating ovarian and other cancers, the drug has not achieved the expected market traction. The company's financial trajectory is marked by significant operating losses and liquidity issues, which may necessitate strategic actions such as restructuring or seeking additional financing.

Key Takeaways

• Competitive Market: RUBRACA faces strong competition from Lynparza and Zejula.
• Regulatory Challenges: Pending approval in Europe and delayed approvals in other settings.
• Financial Struggles: Inconsistent revenues, high operating expenses, and liquidity issues.
• Development Pipeline: Ongoing clinical trials for prostate and bladder cancer, and combination therapies.
• Market Forecast: Potential for growth in the ovarian cancer market despite current challenges.

FAQs

Q1: What is RUBRACA used for? RUBRACA is an oral, small-molecule inhibitor of PARP1, PARP2, and PARP3, primarily used in the treatment of ovarian cancer and being developed for other tumor types such as prostate and bladder cancer.

Q2: How does RUBRACA compare to other PARP inhibitors in the market? RUBRACA faces significant competition from Lynparza (olaparib) and Zejula (niraparib), with Lynparza being the market leader and Zejula also gaining substantial market share.

Q3: What are the financial challenges faced by Clovis Oncology regarding RUBRACA? Clovis Oncology has reported inconsistent and declining revenues from RUBRACA, along with high operating expenses, leading to significant operating losses and liquidity issues.

Q4: What are the regulatory challenges for RUBRACA? RUBRACA's approval in Europe is pending, and the drug is under review for the maintenance setting in the U.S. The regulatory framework has favored first-line maintenance treatments, limiting RUBRACA's market share.

Q5: What are the future development plans for RUBRACA? RUBRACA is being developed for additional indications, including prostate and bladder cancer, and is being explored as a combination therapy with other anticancer agents.

Sources

1. BioPharma Dive: "Rubraca struggling from behind in PARP market"
2. Cloudfront.net: "Clovis Oncology, Inc."
3. NCBI: "MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs"
4. DelveInsight: "RUBRACA Market Size, Forecast, and Drug Insight - 2032"
5. Precision Medicine Online: "Clovis Oncology Exploring Ways to Improve Cash Position, Fund Operations Beyond 2023"