Niraparib tosylate - Generic Drug Details

What are the generic sources for niraparib tosylate and what is the scope of patent protection?

Niraparib tosylate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Niraparib tosylate has two hundred and eighty patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for niraparib tosylate

International Patents:	280
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	3
Patent Applications:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for niraparib tosylate
DailyMed Link:	niraparib tosylate at DailyMed

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

Constraining patent/regulatory exclusivity:

11,091,459

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

11,091,459

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 niraparib tosylate

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

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2
GlaxoSmithKline	Phase 1
Oregon Health and Science University	Phase 1

See all niraparib tosylate clinical trials

Pharmacology for niraparib tosylate

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

Anatomical Therapeutic Chemical (ATC) Classes for niraparib tosylate

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 niraparib tosylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	11,673,877		Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	8,071,579
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No	11,673,877		Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	8,859,562
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	8,143,241
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	11,091,459		Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	8,436,185			Y

International Patents for niraparib tosylate

Country	Patent Number	Title	Estimated Expiration
Japan	4611441
Norway	20063078
China	101578279	Amide substituted indazoles as poly(ADP-ribose)polymerase (PARP) inhibitors
Taiwan	I761476
Japan	5547164
Russian Federation	2010149166	ИНГИБИТОРЫ РЕПАРАЦИИ ПОВРЕЖДЕНИЙ ДНК ДЛЯ ЛЕЧЕНИЯ РАКА
World Intellectual Property Organization (WIPO)	2007113596

Supplementary Protection Certificates for niraparib tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2109608	CA 2018 00017	Denmark		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE; REG. NO/DATE: EU/1/17/1235 20171120
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
2109608	1890020-9	Sweden		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
1633724	122015000025	Germany		PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
2109608	18/2018	Austria		PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, INSBESONDERE DAS TOSYLAT ODER EIN HYDRAT, INSBESONDERE DAS TOSYLAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 (MITTEILUNG) 20171120
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

Niraparib tosylate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Niraparib Tosylate

Introduction

Niraparib tosylate, a potent PARP inhibitor, has emerged as a significant player in the oncology market, particularly for the treatment of ovarian and prostate cancers. This article delves into the market dynamics and financial trajectory of niraparib tosylate, highlighting key drivers, challenges, and future outlook.

Market Size and Growth

The global niraparib tosylate market has experienced substantial growth in recent years. As of 2021, the market size was valued at a significant figure, with a compound annual growth rate (CAGR) from 2016 to 2021. It is projected to continue growing, reaching a market size of several million dollars by 2027, driven by a forecasted CAGR from 2022 to 2027[1].

Key Market Drivers

Rising Cancer Incidence

The increasing prevalence of ovarian and prostate cancers globally is a major driver for the niraparib tosylate market. This rising cancer burden fuels the demand for effective and targeted treatment options, making niraparib tosylate a critical component in cancer therapy[4].

Advancements in Cancer Research

Ongoing research in oncology, particularly in understanding the molecular mechanisms of cancer progression, has led to the development of targeted therapies like niraparib tosylate. These advancements continue to drive the market by providing more precise and effective treatment options[4].

Regulatory Approvals

Regulatory approvals for niraparib tosylate across various jurisdictions have facilitated its commercialization and accessibility to patients. This has been a significant factor in driving market growth, as it expands the drug's reach and potential patient population[4].

Precision Medicine

Niraparib tosylate represents a paradigm shift towards precision medicine, offering personalized treatment options tailored to individual patient profiles and genetic markers. This trend towards precision medicine propels the adoption of niraparib tosylate, contributing to its market growth[4].

Clinical Efficacy

Clinical studies have demonstrated the efficacy of niraparib tosylate in extending progression-free survival (PFS) and improving overall survival rates in patients with advanced ovarian and prostate cancers. For instance, in the NOVA study, niraparib significantly improved PFS in both the gBRCAmut and non-gBRCAmut cohorts compared to placebo[2].

Market Expansion

The approval of niraparib tosylate for additional cancer indications and its inclusion in treatment guidelines have expanded its market reach. This expansion includes applications beyond breast and ovarian cancers, into prostate, pancreatic, and other cancer types, broadening the market scope and contributing to revenue growth[3].

Regional Analysis

North America

The North American market for niraparib tosylate is characterized by robust research infrastructure, high healthcare expenditure, and early adoption of innovative therapies. These factors drive market growth in this region[4].

Europe

Europe represents a significant market for niraparib tosylate, with favorable regulatory frameworks, strong clinical research capabilities, and an increasing incidence of ovarian and prostate cancers. These factors contribute to the market's growth in the region[4].

Asia Pacific

The Asia Pacific region offers untapped growth potential for niraparib tosylate, driven by rising cancer incidence, improving healthcare infrastructure, and increasing awareness of personalized medicine. This region is expected to be a key growth area in the coming years[4].

Latin America and Middle East/Africa

These regions present emerging markets for niraparib tosylate, with opportunities for market expansion driven by evolving healthcare systems, growing disposable incomes, and changing disease demographics[4].

Competitive Landscape

The niraparib tosylate market is part of the broader PARP inhibitors market, which is expected to reach USD 23.5 billion by 2033, growing at a CAGR of 12.1% from 2024 to 2033. The market is competitive, with other PARP inhibitors like olaparib, rucaparib, and talazoparib. However, niraparib tosylate's unique clinical profile and expanding therapeutic indications position it strongly in the market[3].

Financial Trajectory

Current Market Value

As of 2023, the global PARP inhibitors market, which includes niraparib tosylate, was valued at approximately USD 7.9 billion. It is expected to reach USD 8.4 billion in 2024 and grow significantly to USD 23.5 billion by 2033[3].

Future Projections

The financial trajectory for niraparib tosylate is promising, driven by the growing demand for targeted cancer therapies and the drug's expanding applications. The market is expected to benefit from ongoing research, regulatory approvals, and the increasing adoption of precision medicine.

Challenges and Opportunities

Regulatory Hurdles

Despite the growth potential, the niraparib tosylate market faces regulatory hurdles and competition from alternative therapies. Navigating these challenges while addressing unmet medical needs will be crucial for stakeholders[4].

Pricing Pressures

Pricing pressures are another challenge, as healthcare systems and payers increasingly scrutinize the cost-effectiveness of new therapies. Pharmaceutical companies must balance pricing strategies with the need to invest in research and development[4].

Combination Therapies

The exploration of combination therapies, such as niraparib tosylate with immunotherapies or other targeted agents, represents a dynamic trend and a significant opportunity for market growth. These combinations can enhance treatment outcomes and expand the patient population[3].

Key Takeaways

• Growing Demand: The rising incidence of ovarian and prostate cancers drives the demand for niraparib tosylate.
• Clinical Efficacy: Niraparib tosylate has demonstrated significant clinical efficacy in extending PFS and improving overall survival rates.
• Market Expansion: The drug's market reach is expanding beyond traditional indications into other cancer types.
• Regional Growth: North America, Europe, and the Asia Pacific are key regions driving market growth.
• Financial Growth: The market is projected to grow significantly, reaching USD 23.5 billion by 2033.

FAQs

What is niraparib tosylate used for?

Niraparib tosylate is primarily used for the treatment of ovarian and prostate cancers, particularly in patients who have received prior platinum-based chemotherapy.

What are the key drivers of the niraparib tosylate market?

Key drivers include the rising incidence of ovarian and prostate cancers, advancements in cancer research, regulatory approvals, and the trend towards precision medicine.

What are the common adverse reactions associated with niraparib tosylate?

Common adverse reactions include thrombocytopenia, anemia, neutropenia, leukopenia, nausea, constipation, vomiting, abdominal pain, fatigue, and hypertension[2].

How does niraparib tosylate compare to other PARP inhibitors?

Niraparib tosylate competes with other PARP inhibitors like olaparib, rucaparib, and talazoparib but has a unique clinical profile and expanding therapeutic indications that position it strongly in the market.

What is the projected market size of niraparib tosylate by 2033?

The global PARP inhibitors market, which includes niraparib tosylate, is expected to reach USD 23.5 billion by 2033, growing at a CAGR of 12.1% from 2024 to 2033[3].

Sources

1. Global Niraparib Tosylate Market Status, Trends and COVID-19 Impact Report 2022. Market Publishers.
2. FDA Approval Document for Niraparib. FDA.
3. Global PARP Inhibitors Market Size, Trends and Insights. Custom Market Insights.
4. Niraparib Tosylate Market 2024-2032. Market Wide Research.
5. Clinical Review - Niraparib and Abiraterone Acetate. NCBI.