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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Two suppliers are listed for this compound.

Summary for RUCAPARIB CAMSYLATE

International Patents:	234
US Patents:	11
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	209115-002	Dec 19, 2016		RX	Yes	Yes	8,071,579
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No	7,531,530
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	10,278,974		Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No	10,278,974		Y
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes	8,859,562

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	6,495,541
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016	7,531,530
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016	7,351,701
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	6,495,541

International Patents for RUCAPARIB CAMSYLATE

Country	Patent Number	Title	Estimated Expiration
Morocco	27758	DERIVES DE PHTALAZINONE
New Zealand	545307	Use of RNAI inhibiting parp activity for the manufacture of a medicament for the treatment of cancer
Japan	2007516241
Spain	2545613
Japan	2021038242	ルカパリブの高投与力価錠剤 (HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB)
Norway	20063078

Supplementary Protection Certificates for RUCAPARIB CAMSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2534153	300958	Netherlands		PRODUCT NAME: RUCAPARIB CAMSYLAAT; REGISTRATION NO/DATE: EU/1/17/1250 20180529
1633724	C01633724/01	Switzerland		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
1633724	92680	Luxembourg		PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
2534153	48/2018	Austria		PRODUCT NAME: RUCAPARIBCAMSYLAT; REGISTRATION NO/DATE: EU/1/17/1250 (MITTEILUNG) 20180529
1633724	122015000025	Germany		PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
2534153	1890042-3	Sweden		PRODUCT NAME: RUCAPARIB CAMSYLATE; REG. NO/DATE: EU/1/17/1250 20180529

RUCAPARIB CAMSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rucaparib Camsylate

Introduction

Rucaparib camsylate, marketed as Rubraca, is a PARP (poly (ADP-ribose) polymerase) inhibitor that has been making significant strides in the oncology market. Here, we will delve into the market dynamics and financial trajectory of this drug, exploring its current status, future prospects, and the factors influencing its market position.

Current Market Status

Approved Indications

Rucaparib camsylate is currently approved for the treatment of several types of cancer, including ovarian epithelial, fallopian tube, and primary peritoneal cancer, as well as metastatic prostate cancer with BRCA1 or BRCA2 mutations[5].

Clinical Development

The drug is under various stages of clinical development for other cancer types, such as triple-negative breast cancer (TNBC), metastatic biliary tract cancer, and several other solid tumors. For TNBC, it is in Phase I, with an 81% phase transition success rate (PTSR) benchmark for progressing into Phase II[1]. For metastatic biliary tract cancer, it is in Phase II, although there is insufficient historical data to establish a PTSR benchmark for this indication[4].

Market Size and Growth

Global PARP Inhibitors Market

The global PARP inhibitors market, which includes rucaparib camsylate, is projected to grow significantly. As of 2023, the market size was approximately USD 7.9 billion and is expected to reach USD 8.4 billion in 2024. By 2033, the market is forecasted to expand to USD 23.5 billion, with a CAGR of 12.1% from 2023 to 2033[3].

Competitive Landscape

The PARP inhibitors market is competitive, with other drugs like olaparib, niraparib, and talazoparib also vying for market share. However, rucaparib camsylate's broad range of potential indications and its ongoing clinical trials position it strongly in this competitive landscape.

Financial Impact and Budget Considerations

Budget Impact Analysis

Studies have shown that the inclusion of rucaparib camsylate in a health plan's formulary has a negligible budget impact. For instance, in the maintenance setting, the average incremental budget impact over three years was estimated to be USD 3,693, translating to less than USD 0.001 per member per month (PMPM)[2].

Cost of Treatment

The total expenditures for treatment with rucaparib camsylate are relatively high but comparable to other treatments. For example, in the treatment setting, the average total expenditures over three years were estimated to be USD 1,320,718 with rucaparib versus USD 1,313,736 without it[2].

Key Factors Influencing Market Dynamics

Clinical Trials and Approval Process

The success of rucaparib camsylate in clinical trials is crucial for its market dynamics. GlobalData's proprietary data and analytics track drug-specific phase transition and likelihood of approval scores, which are essential for predicting the drug's future market performance[1][4].

Regulatory Environment

Regulatory approvals and the FDA's Accelerated Approval Program play a significant role. For instance, rucaparib camsylate's approval for metastatic prostate cancer was granted under this program, with the condition that confirmatory trials must show clinical benefit[5].

Patient Population and Incidence

The incidence of the cancers rucaparib camsylate is indicated for or being studied for affects its market potential. For example, the higher incidence of ovarian cancer in the over-65 population impacts the budget impact analysis differently for commercial plans versus Medicare[2].

Future Prospects

Expanding Indications

Rucaparib camsylate is being studied for a wide range of solid tumors, including metastatic pancreatic cancer, leiomyosarcoma, and non-small cell lung cancer. Successful outcomes in these trials could significantly expand its market share[4].

Market Competition

The escalating competition in the PARP inhibitors market, driven by the entry of new drugs and the expansion of existing ones, will continue to shape the market dynamics. Companies like Pharmaand, the developer of rucaparib camsylate, must adapt to these competitive pressures to maintain market position[3].

Conclusion

Rucaparib camsylate is poised for significant growth in the oncology market, driven by its expanding indications, ongoing clinical trials, and favorable market forecasts. The drug's financial trajectory is influenced by its clinical success, regulatory environment, and competitive landscape.

Key Takeaways

• Market Growth: The global PARP inhibitors market is expected to reach USD 23.5 billion by 2033.
• Clinical Development: Rucaparib camsylate is in various stages of clinical development for multiple cancer types.
• Financial Impact: The drug has a negligible budget impact on health plans.
• Regulatory Environment: Regulatory approvals and ongoing trials are crucial for its market success.
• Competitive Landscape: The market is competitive, but rucaparib camsylate's broad potential indications position it strongly.

FAQs

What is rucaparib camsylate used for?

Rucaparib camsylate is used as a treatment for ovarian epithelial, fallopian tube, and primary peritoneal cancer, as well as metastatic prostate cancer with BRCA1 or BRCA2 mutations[5].

What is the current phase of rucaparib camsylate for triple-negative breast cancer?

Rucaparib camsylate is currently in Phase I for triple-negative breast cancer (TNBC)[1].

How does the inclusion of rucaparib camsylate affect health plan budgets?

The inclusion of rucaparib camsylate in a health plan's formulary has a negligible budget impact, with an average incremental budget impact of less than USD 0.001 per member per month (PMPM)[2].

What is the projected market size of the global PARP inhibitors market by 2033?

The global PARP inhibitors market is expected to reach USD 23.5 billion by 2033[3].

Who is the developer of rucaparib camsylate?

Rucaparib camsylate is developed by Pharmaand GmbH[1][4].

Sources

1. Pharmaceutical Technology: "Rucaparib camsylate by Pharmaand for Triple-Negative Breast Cancer (TNBC) Likelihood of Approval"
2. PubMed: "The Budget Impact of Including Rucaparib on a US Payer Formulary"
3. GlobeNewswire: "Latest Global PARP Inhibitors Market Size/Share Worth USD 23.5 Billion by 2032 at a 12.1% CAGR"
4. Pharmaceutical Technology: "Rucaparib camsylate by Pharmaand for Metastatic Biliary Tract Cancer"
5. National Cancer Institute: "Rucaparib Camsylate"