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Last Updated: December 22, 2024

GRANISOL Drug Patent Profile


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

Granisol is a drug marketed by Intra Sana Labs and is included in one NDA.

The generic ingredient in GRANISOL is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Granisol

A generic version of GRANISOL was approved as granisetron hydrochloride by AMNEAL on December 31st, 2007.

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Summary for GRANISOL
Drug patent expirations by year for GRANISOL
Recent Clinical Trials for GRANISOL

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

SponsorPhase
Tesaro, Inc.Phase 3
University of MiamiPhase 2

See all GRANISOL clinical trials

US Patents and Regulatory Information for GRANISOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intra Sana Labs GRANISOL granisetron hydrochloride SOLUTION;ORAL 078334-001 Feb 28, 2008 DISCN 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

GRANISOL Market Analysis and Financial Projection Experimental

Granisetron Market Dynamics and Financial Trajectory

Market Overview

Granisetron, a serotonin-3 receptor antagonist, is a crucial medication for managing chemotherapy-induced nausea and vomiting (CINV) and other conditions such as gastroparesis. The market for granisetron is poised for significant growth, driven by several key factors.

Market Drivers

Rise in Chemotherapy and Radiotherapy Visits

The increasing burden of cancer globally is a primary driver for the granisetron market. As the number of cancer cases rises, so does the demand for chemotherapy and radiotherapy treatments. These treatments often cause CINV, for which granisetron is a highly effective treatment. For instance, the American Cancer Society estimates that 2 million cancer cases will be diagnosed in the United States in 2024, up from 1.9 million in 2023, indicating a growing need for granisetron[4].

Increasing Incidence of Gastroparesis

Gastroparesis, a condition characterized by delayed stomach emptying, is another factor driving the demand for granisetron. The growing prevalence of this condition, particularly among diabetic patients, further expands the market for granisetron[1][4].

Market Restraints

Adverse Effects of Granisetron

Despite its efficacy, granisetron is associated with potential adverse effects such as constipation, headache, and dizziness. These side effects can limit its adoption and impact market growth. However, ongoing research and the development of new formulations aim to mitigate these issues[1].

Market Segmentation

By Product Type

The granisetron market is segmented into various product types, including transdermal systems, injections, and oral formulations. The availability of these different forms enhances the accessibility and usage of granisetron, catering to different patient needs and preferences[1].

By Application

Granisetron is primarily used in two main applications:

  • Chemotherapy: This is the largest segment, driven by the increasing number of chemotherapy sessions.
  • Post-operative: Granisetron is also used to prevent post-operative nausea and vomiting (PONV)[1].

By Geography

North America

North America holds the largest market share due to the high burden of cancer cases and the increasing adoption of granisetron among patients undergoing chemotherapy and radiotherapy. The region is expected to continue its dominance during the forecast period[4].

Asia-Pacific

The Asia-Pacific region is anticipated to be the fastest-growing segment, driven by the rising incidence of cancer and the growing healthcare infrastructure in countries like China, Japan, and India[4].

Competitive Landscape

The granisetron market is characterized by a semi-consolidated structure with key players such as:

  • Kyowa Kirin Co., Ltd.
  • Heron Therapeutics, Inc.
  • Viatris
  • Hikma Pharmaceuticals PLC
  • Fresenius SE & Co. KGaA

These companies are actively involved in strategic initiatives like product launches, acquisitions, and research and development to strengthen their market position[1][4].

Financial Trajectory

Market Size and Growth

The granisetron market is projected to register a Compound Annual Growth Rate (CAGR) of 6.20% during the forecast period from 2024 to 2029. This growth is driven by the increasing demand for granisetron due to the rising burden of cancer and the growing prevalence of gastroparesis[1][4].

Revenue and Profitability

The market's financial trajectory is expected to be robust, with significant revenue growth anticipated. Key players are focusing on improving operational efficiencies, enhancing product mix, and engaging in strategic acquisitions to boost profitability. For example, the high adoption of granisetron in North America, particularly in the United States, contributes substantially to the overall revenue[1][4].

Research and Development

Ongoing research and clinical trials are crucial for the market's growth. Studies are exploring the potential of granisetron in various settings, including its use in pediatric patients and its combination with other medications to enhance its effectiveness. These efforts are expected to further stimulate market expansion[1].

Regional Insights

North America

The high cancer burden in North America, especially in the United States, drives the demand for granisetron. The region's advanced healthcare infrastructure and the availability of various granisetron formulations contribute to its significant market share[4].

Asia-Pacific

The Asia-Pacific region is expected to experience rapid growth due to the increasing incidence of cancer and the expansion of healthcare services. Countries like China, Japan, and India are key contributors to this growth[4].

Porter's Five Forces Analysis

Threat of New Entrants

The threat of new entrants is moderate due to the regulatory hurdles and the need for significant investment in research and development. However, generic versions of granisetron can enter the market post-patent expiration, which could increase competition[1].

Bargaining Power of Buyers/Consumers

The bargaining power of buyers is relatively low due to the lack of substitutes for granisetron in managing CINV and gastroparesis. However, as more generic versions enter the market, buyers may gain more negotiating power[1].

Bargaining Power of Suppliers

The bargaining power of suppliers is moderate, as the market relies on a few key suppliers for the active pharmaceutical ingredient (API) and other components. Strategic partnerships and long-term contracts can mitigate this risk[1].

Threat of Substitute Products

The threat of substitute products is low, as granisetron is a highly effective medication for its specific indications. However, other antiemetic drugs may pose some competition, although they often have different mechanisms of action and side effect profiles[1].

Intensity of Competitive Rivalry

The intensity of competitive rivalry is high among the existing players, who engage in various strategies such as product launches, acquisitions, and pricing competitions to maintain their market share[1].

Key Takeaways

  • The granisetron market is expected to grow at a CAGR of 6.20% from 2024 to 2029.
  • The rise in chemotherapy and radiotherapy visits, along with the increasing prevalence of gastroparesis, are key drivers of market growth.
  • North America holds the largest market share, while the Asia-Pacific region is expected to be the fastest-growing segment.
  • Key players are focusing on strategic initiatives and research to strengthen their market position.
  • Ongoing research and clinical trials are crucial for the market's continued growth.

FAQs

What is the current Granisetron Market size and growth rate?

The Granisetron Market is projected to register a CAGR of 6.20% during the forecast period (2024-2029)[1][4].

Who are the key players in the Granisetron Market?

Key players include Kyowa Kirin Co., Ltd., Heron Therapeutics, Inc., Viatris, Hikma Pharmaceuticals PLC, and Fresenius SE & Co. KGaA[1][4].

Which region has the biggest share in the Granisetron Market?

In 2024, North America accounts for the largest market share in the Granisetron Market[4].

Which region is expected to grow the fastest in the Granisetron Market?

The Asia-Pacific region is estimated to grow at the highest CAGR over the forecast period (2024-2029)[4].

What are the main applications of Granisetron?

Granisetron is primarily used in chemotherapy and post-operative settings to prevent nausea and vomiting[1].

Sources

  1. Mordor Intelligence: Granisetron Market Size - Mordor Intelligence
  2. Annual Reports: HEALTHY FUTURES - Annual Reports
  3. Federal Trade Commission: Generic Drug Industry Dynamics - Federal Trade Commission
  4. Mordor Intelligence: Granisetron Market Size & Share Analysis - Industry Research Report
  5. Annual Reports: APRICUS BIOSCIENCES, INC. - Annual Reports

More… ↓

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