Pazopanib hydrochloride - Generic Drug Details

What are the generic sources for pazopanib hydrochloride and what is the scope of patent protection?

Pazopanib hydrochloride is the generic ingredient in two branded drugs marketed by Apotex, Novugen, Sun Pharm, Teva Pharms Inc, and Novartis, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for pazopanib hydrochloride. Seven suppliers are listed for this compound.

Summary for pazopanib hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	285
Patent Applications:	1,115
What excipients (inactive ingredients) are in pazopanib hydrochloride?	pazopanib hydrochloride excipients list
DailyMed Link:	pazopanib hydrochloride at DailyMed

Recent Clinical Trials for pazopanib hydrochloride

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

Sponsor	Phase
University Medical Center Groningen	Phase 4
Alliance for Clinical Trials in Oncology	Phase 2/Phase 3
Shenzhen Chipscreen Biosciences Co.Ltd	Phase 2

See all pazopanib hydrochloride clinical trials

Pharmacology for pazopanib hydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for pazopanib hydrochloride

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for pazopanib hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009		DISCN	Yes	No
Novugen	PAZOPANIB HYDROCHLORIDE	pazopanib hydrochloride	TABLET;ORAL	218231-001	Apr 23, 2024	AB	RX	No	No
Sun Pharm	PAZOPANIB HYDROCHLORIDE	pazopanib hydrochloride	TABLET;ORAL	215837-001	Oct 19, 2023	AB	RX	No	No

Expired US Patents for pazopanib hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-001	Oct 19, 2009	7,105,530
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	8,114,885
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465-002	Oct 19, 2009	7,262,203

Pazopanib hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pazopanib Hydrochloride

Introduction

Pazopanib hydrochloride, marketed under the brand name Votrient, is a vascular endothelial growth factor receptor-2 (VEGFR2) tyrosine kinase inhibitor developed by GlaxoSmithKline. It is primarily used for the treatment of advanced renal cell carcinoma (RCC) and soft tissue sarcoma. Here, we delve into the market dynamics and financial trajectory of pazopanib hydrochloride.

Market Size and Growth Projections

The global pazopanib HCl API market is experiencing significant growth, driven by increasing demand in the pharmaceutical sector. As of 2023, the market size is substantial, and projections indicate a continued expansion from 2024 to 2031. The compound annual growth rate (CAGR) for this period is expected to be robust, reflecting the upward trend in market dynamics[1][4].

Segmentation and Key Applications

The pazopanib HCl API market is segmented based on type and application. The types include Min Purity Less Than 98%, Min Purity 98%-99%, and Min Purity More Than 99%. The primary applications are in research and pharmaceutical sectors. The Research segment is anticipated to expand at a significant CAGR, retaining its position throughout the forecast period[1][4].

Geographical Analysis

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own growth trajectory, influenced by local healthcare policies, market penetration, and economic conditions. Asia-Pacific is expected to be a key growth driver due to increasing healthcare expenditure and a large patient population[1][4].

Key Players and Competitive Landscape

The market is dominated by several key players, including Tecoland, FCDA, BIOBERRY, Abcr, Dr. Reddys Laboratories, and others. These companies are focusing on strategy building models to strengthen their product portfolios and expand their business globally. The competitive landscape is characterized by intense research and development activities aimed at improving product quality and expanding therapeutic indications[1][4].

Therapeutic Indications and Clinical Trials

Pazopanib hydrochloride has been approved for the treatment of advanced RCC and soft tissue sarcoma. It has shown significant efficacy in clinical trials, particularly in the VEG105192 study, where it demonstrated a median progression-free survival of 9.2 months compared to 4.2 months for the placebo arm[2].

Clinical Trials Overview

• VEG10003: A phase I dose-finding study that established the maximum tolerated dose of 800 mg once daily.
• VEG105192: A phase III study that confirmed the efficacy and safety of pazopanib in patients with advanced RCC[2].

Regulatory Approvals

Pazopanib received a conditional marketing authorization from the European Commission in June 2010 for the treatment of advanced RCC. This approval was based on a positive benefit-risk balance assessed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)[2].

Financial Performance and Commercial Success

The commercial success of pazopanib hydrochloride can be attributed to its therapeutic advantage and timely market entry. While being the first in class is slightly more advantageous, having a proven therapeutic advantage is crucial for long-term success. Pazopanib, despite not being the first in its class, has captured significant market share due to its efficacy and manageable safety profile[3].

Revenue and Sales

The revenue generated by pazopanib hydrochloride is substantial, with the global market size expected to grow significantly over the forecast period. The financial performance is influenced by factors such as product pricing, market penetration, and competition within the therapeutic class[1][4].

Market Drivers and Opportunities

Several factors drive the growth of the pazopanib HCl API market:

• Increasing Incidence of Cancer: The rising incidence of renal cell carcinoma and other cancers for which pazopanib is indicated drives demand.
• Advancements in Healthcare: Improvements in healthcare infrastructure and increasing healthcare expenditure in emerging markets.
• Research and Development: Ongoing R&D activities to explore new therapeutic indications and improve product quality[1][4].

Market Restraints and Challenges

Despite the growth potential, the market faces several challenges:

• Regulatory Hurdles: Strict regulatory requirements and the need for continuous monitoring of safety and efficacy.
• Competition: Presence of other tyrosine kinase inhibitors and potential generic competition.
• Economic Factors: Fluctuations in global economic conditions and pricing pressures[1][4].

Technological and Manufacturing Trends

Key manufacturers are focusing on technological advancements to produce high-quality chemicals. The manufacturing process involves stringent quality control measures to ensure the purity and efficacy of the API. The segment analysis helps in understanding the most attractive application/end-use sectors and their expected growth rates[4].

Consumer Behavior and Market Attractiveness

Consumer behavior, particularly in the pharmaceutical sector, is influenced by the efficacy, safety, and cost of treatments. The market attractiveness is high due to the increasing demand for effective cancer treatments and the expanding patient population. The report provides detailed insights into consumer behavior and market attractiveness, helping stakeholders make informed decisions[4].

Key Takeaways

• Market Growth: The global pazopanib HCl API market is expected to grow significantly from 2024 to 2031.
• Segmentation: The market is segmented by type and application, with the Research segment expected to expand significantly.
• Geographical Analysis: Asia-Pacific is a key growth driver due to increasing healthcare expenditure and a large patient population.
• Therapeutic Indications: Pazopanib is approved for advanced RCC and soft tissue sarcoma, with ongoing trials for other cancer types.
• Financial Performance: The drug has achieved significant commercial success due to its therapeutic advantage and timely market entry.

FAQs

What is the primary therapeutic indication for pazopanib hydrochloride?

Pazopanib hydrochloride is primarily used for the treatment of advanced renal cell carcinoma (RCC) and soft tissue sarcoma.

What is the expected growth rate of the global pazopanib HCl API market?

The global pazopanib HCl API market is expected to grow at a robust compound annual growth rate (CAGR) from 2024 to 2031.

Which regions are expected to drive the growth of the pazopanib HCl API market?

Asia-Pacific is expected to be a key growth driver due to increasing healthcare expenditure and a large patient population.

What are the key factors driving the growth of the pazopanib HCl API market?

The growth is driven by the increasing incidence of cancer, advancements in healthcare, and ongoing research and development activities.

Who are the key players in the pazopanib HCl API market?

Key players include Tecoland, FCDA, BIOBERRY, Abcr, Dr. Reddys Laboratories, and others.

Sources

1. Market Research Intellect: Global Pazopanib HCl API Market Size, Scope And Forecast Report.
2. AACR Journals: The European Medicines Agency Review of Pazopanib.
3. Boston Consulting Group: What matters most in commercial success: first-in-class or best-in-class.
4. Cognitive Market Research: Global Pazopanib HCl API Market Report 2024 Edition.
5. AdisInsight - Springer: Pazopanib - GlaxoSmithKline/Novartis.