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Last Updated: January 8, 2025

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE Drug Patent Profile


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Which patents cover Granisetron Hydrochloride Preservative Free, and when can generic versions of Granisetron Hydrochloride Preservative Free launch?

Granisetron Hydrochloride Preservative Free is a drug marketed by Bionpharma, Dr Reddys, and Fresenius Kabi Usa. and is included in three NDAs.

The generic ingredient in GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE 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 Granisetron Hydrochloride Preservative Free

A generic version of GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE was approved as granisetron hydrochloride by AMNEAL on December 31st, 2007.

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Summary for GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
Drug patent expirations by year for GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
Pharmacology for GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

US Patents and Regulatory Information for GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bionpharma GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE granisetron hydrochloride INJECTABLE;INJECTION 078863-002 Jun 30, 2008 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE granisetron hydrochloride INJECTABLE;INJECTION 077165-001 Dec 31, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE granisetron hydrochloride INJECTABLE;INJECTION 078096-001 Jun 30, 2008 AP RX No Yes ⤷  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

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE Market Analysis and Financial Projection

Granisetron Hydrochloride Market Dynamics and Financial Trajectory

Introduction to Granisetron Hydrochloride

Granisetron hydrochloride is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist, widely used to prevent nausea and vomiting caused by chemotherapy, radiation therapy, and postoperative recovery. Its effectiveness and convenience have made it a crucial component in the management of these symptoms.

Market Size and Growth Projections

The granisetron hydrochloride market has been valued at USD 1.4 billion in 2023 and is projected to reach USD 2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.2% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Cancer Cases and Chemotherapy Use

The rising incidence of cancer is a significant driver of the granisetron hydrochloride market. With an estimated 2 million cancer cases expected to be diagnosed in the United States in 2024, up from 1.9 million in 2023, the demand for chemotherapy and radiotherapy is increasing, thereby driving the need for antiemetic drugs like granisetron[2][4].

Expansion of Healthcare Infrastructure

The global expansion of healthcare infrastructure, particularly in developing regions, is accelerating the adoption of advanced antiemetic treatments such as granisetron hydrochloride. This expansion enhances access to healthcare services, contributing to market growth[3].

Technological Advancements in Drug Formulations

Advancements in medication delivery technologies and medical technology are improving the effectiveness and convenience of granisetron hydrochloride. These innovations are crucial in enhancing patient-centric care and better drug delivery systems[1].

Favorable Reimbursement Policies

Favorable reimbursement policies for antiemetic medications are encouraging the widespread use of granisetron hydrochloride. These policies make the drug more accessible to patients, thereby boosting market demand[3].

Market Segmentation

Application Segments

The market is segmented based on application, including oral tablets, injection solutions, and patch formulations. Each segment has its own growth trajectory, with oral tablets being a dominant form due to ease of administration and patient compliance[1].

Product Segments

The market is also segmented by product, focusing on nausea and vomiting, chemotherapy-induced nausea, and postoperative nausea. The chemotherapy-induced nausea segment is particularly significant due to the high incidence of cancer and the subsequent need for chemotherapy[1].

Geographical Segments

Geographically, North America is expected to hold a significant share in the market due to the high burden of cancer cases and the increasing prevalence of gastroparesis. The Asia-Pacific region is also expected to grow at a high CAGR during the forecast period[2][4].

Challenges and Restraints

Side Effects and Regulatory Challenges

Despite its effectiveness, granisetron hydrochloride faces challenges such as side effects associated with the drug and regulatory hurdles. The need for robust clinical trials to expand its approved uses is an ongoing challenge[3].

Patent Expiration and Generic Competition

The patent expiration of granisetron hydrochloride can lead to an influx of generic competitors, impacting market pricing and profitability. This competition requires innovative strategies to maintain market share[3].

Supply Chain Vulnerabilities

Supply chain vulnerabilities can impact the consistent availability of granisetron hydrochloride, which is a critical factor in maintaining market stability and patient access to the drug[3].

Market Opportunities

Innovative Oncology Therapeutics

Leveraging granisetron hydrochloride for innovative oncology therapeutics and improving cancer patient care is a significant opportunity. Research on alternative applications of granisetron in other nausea-related conditions or combination therapies can enhance its efficacy and market position[3].

Expanding Off-Label Uses

Expanding the off-label uses of granisetron hydrochloride in treating gastrointestinal disorders and nausea presents a potential growth area. Integrating granisetron into personalized medicine approaches can also lead to better patient outcomes and increased market penetration[3].

Key Players and Strategic Collaborations

Major companies operating in the granisetron hydrochloride market include Kyowa Kirin Co., Ltd., Heron Therapeutics, Inc., Viatris, Hikma Pharmaceuticals PLC, and Fresenius SE & Co. KGaA. Strategic collaborations between these pharmaceutical companies drive innovation and market penetration of granisetron hydrochloride[4].

Financial Trajectory

The granisetron hydrochloride market is expected to continue growing, driven by the increasing demand for antiemetic drugs. Here are some key financial metrics:

  • Market Size: The market was valued at USD 1.4 billion in 2023 and is expected to reach USD 2 billion by 2031[1].
  • CAGR: The market is projected to grow at a CAGR of 5.2% from 2024 to 2031[1].
  • Revenue Growth: The market grew from USD 7.01 billion in 2023 to USD 7.43 billion in 2024, with a projected CAGR of 6.58% until 2030[3].

Regional Performance

North America

North America is expected to hold a significant share in the market due to the high burden of cancer cases and the increasing prevalence of gastroparesis. The region's advanced healthcare infrastructure and favorable reimbursement policies further support market growth[2][4].

Asia-Pacific

The Asia-Pacific region is estimated to grow at the highest CAGR during the forecast period. This growth is driven by the expanding healthcare infrastructure and increasing healthcare expenditure in this region[4].

Pharmacokinetics and Efficacy

Granisetron hydrochloride has been shown to be highly effective in preventing nausea and vomiting. Pharmacokinetic studies have demonstrated its efficacy in various dosages, including 0.25 mg to 2 mg twice a day, with significant results in preventing nausea and vomiting post-chemotherapy[5].

"Granisetron hydrochloride tablets 2 mg daily were statistically superior to prochlorperazine (PCPZ), 10 mg twice a day, derived from a historical control. The 24 hour results for granisetron hydrochloride tablets 2 mg daily were statistically superior to PCPZ for all efficacy parameters: complete response (58%), no vomiting (79%), no nausea (51%), total control (49%)"[5].

Key Takeaways

  • The granisetron hydrochloride market is driven by the increasing incidence of cancer and the subsequent need for chemotherapy and radiotherapy.
  • Technological advancements and favorable reimbursement policies are key factors propelling market growth.
  • North America holds a significant market share, while the Asia-Pacific region is expected to grow at the highest CAGR.
  • The market faces challenges such as side effects, regulatory hurdles, and generic competition.
  • Strategic collaborations and innovative applications are crucial for maintaining market competitiveness.

FAQs

What is the current market size of the granisetron hydrochloride market?

The granisetron hydrochloride market was valued at USD 1.4 billion in 2023[1].

What is the projected CAGR for the granisetron hydrochloride market from 2024 to 2031?

The market is projected to grow at a CAGR of 5.2% from 2024 to 2031[1].

Which region is expected to hold the largest market share in the granisetron hydrochloride market?

North America is expected to hold the largest market share in the granisetron hydrochloride market[2][4].

What are the key drivers of the granisetron hydrochloride market?

Key drivers include the increasing incidence of cancer, expansion of healthcare infrastructure, technological advancements, and favorable reimbursement policies[1][3].

What challenges does the granisetron hydrochloride market face?

The market faces challenges such as side effects, regulatory hurdles, patent expiration, and generic competition[3].

Sources

  1. Marketresearchintellect: Granisetron Hydrochloride Market Size and Projections
  2. Mordor Intelligence: Granisetron Market Trends
  3. ResearchandMarkets: Granisetron Market Size, Competitors & Forecast to 2030
  4. Mordor Intelligence: Granisetron Market Size & Share Analysis - Industry Research Report
  5. DailyMed: GRANISETRON HYDROCHLORIDE tablet, film coated

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