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Last Updated: December 23, 2024

PAZOPANIB HYDROCHLORIDE Drug Patent Profile


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When do Pazopanib Hydrochloride patents expire, and what generic alternatives are available?

Pazopanib Hydrochloride is a drug marketed by Apotex, Novugen, Sun Pharm, and Teva Pharms Inc. and is included in four NDAs.

The generic ingredient in PAZOPANIB HYDROCHLORIDE is pazopanib hydrochloride. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the pazopanib hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pazopanib Hydrochloride

A generic version of PAZOPANIB HYDROCHLORIDE was approved as pazopanib hydrochloride by APOTEX on October 19th, 2023.

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Drug patent expirations by year for PAZOPANIB HYDROCHLORIDE
Recent Clinical Trials for PAZOPANIB HYDROCHLORIDE

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

SponsorPhase
University Medical Center GroningenPhase 4
Alliance for Clinical Trials in OncologyPhase 2/Phase 3
Shenzhen Chipscreen Biosciences Co.LtdPhase 2

See all PAZOPANIB HYDROCHLORIDE clinical trials

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
Apotex PAZOPANIB HYDROCHLORIDE pazopanib hydrochloride TABLET;ORAL 217713-001 Oct 19, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Inc PAZOPANIB HYDROCHLORIDE pazopanib hydrochloride TABLET;ORAL 217517-001 Oct 19, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novugen PAZOPANIB HYDROCHLORIDE pazopanib hydrochloride TABLET;ORAL 218231-001 Apr 23, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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