Granisetron hydrochloride - Generic Drug Details

What are the generic sources for granisetron hydrochloride and what is the scope of freedom to operate?

Granisetron hydrochloride is the generic ingredient in four branded drugs marketed by Am Regent, Amneal, Baxter Hlthcare Corp, Bionpharma, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Mylan Asi, Norvium Bioscience, Rising, Sandoz, Sandoz Inc, Teva Pharms Usa, Wockhardt Usa, Yung Shin Pharm, Roche, Intra Sana Labs, Apotex Inc, Aurobindo Pharma Usa, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Natco Pharma, Orbion Pharms, Taro, and Teva Pharms, and is included in fifty NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for granisetron hydrochloride. Seven suppliers are listed for this compound.

Summary for granisetron hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	29
NDAs:	50
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	125
Patent Applications:	3,348
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for granisetron hydrochloride
What excipients (inactive ingredients) are in granisetron hydrochloride?	granisetron hydrochloride excipients list
DailyMed Link:	granisetron hydrochloride at DailyMed

Recent Clinical Trials for granisetron hydrochloride

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Guangxi Medical University	Phase 3
Heron Therapeutics	Phase 4

See all granisetron hydrochloride clinical trials

Pharmacology for granisetron hydrochloride

Drug Class	Serotonin-3 Receptor Antagonist
Mechanism of Action	Serotonin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for granisetron hydrochloride

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for GRANISETRON HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYTRIL	Injection	granisetron hydrochloride	0.1 mg/mL, 1 mL single dose vial	020239	1	2007-03-08
KYTRIL	Injection	granisetron hydrochloride	1 mg/mL, 4 mL multi-dose vials	020239	1	2004-07-19
KYTRIL	Injection	granisetron hydrochloride	1 mg/mL, 1 mL vials	020239	1	2004-06-01

US Patents and Regulatory Information for granisetron hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078522-001	Dec 31, 2007	AP	RX	No	No
Roche	KYTRIL	granisetron hydrochloride	TABLET;ORAL	020305-002	Jun 15, 1998		DISCN	Yes	No
Eugia Pharma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	204238-002	Jul 6, 2016		DISCN	No	No
Amneal	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078258-002	Jun 30, 2008	AP	RX	No	No
Hikma Farmaceutica	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	078629-001	Dec 23, 2009	AP	RX	No	No
Eugia Pharma	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	204238-001	Jul 6, 2016		DISCN	No	No
Yung Shin Pharm	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	202648-001	Jun 29, 2020		DISCN	No	No

Expired US Patents for granisetron hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-002	Mar 11, 1994
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-003	Sep 17, 2004
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993
Roche	KYTRIL	granisetron hydrochloride	SOLUTION;ORAL	021238-001	Jun 27, 2001
Roche	KYTRIL	granisetron hydrochloride	INJECTABLE;INJECTION	020239-001	Dec 29, 1993

Granisetron hydrochloride Market Analysis and Financial Projection Experimental

Granisetron Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

The Granisetron Hydrochloride market is poised for significant growth, driven by several key factors. This market, valued at USD 1.4 billion in 2023, 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

Rise in Cancer Cases

The increasing incidence of cancer is a primary driver of the granisetron 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 on the rise. This, in turn, increases the need for antiemetic drugs like granisetron to manage chemotherapy-induced nausea and vomiting[2][4].

Advancements in Drug Formulations

Technological advancements in drug delivery systems and formulations are enhancing the effectiveness and convenience of granisetron. These improvements are crucial in patient-centric care, contributing to the market's growth[1].

Healthcare Infrastructure Expansion

The global expansion of healthcare infrastructure and increased healthcare spending per capita are significant factors driving the market. Better access to healthcare services, especially in developed nations, is boosting the demand for granisetron[1][3].

Geographical Market Analysis

North America

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

Asia-Pacific

The Asia-Pacific region is anticipated to be the fastest-growing market for granisetron, driven by the rising incidence of cancer and other medical conditions requiring chemotherapy and radiotherapy. This region's growing healthcare infrastructure and increasing demand for antiemetic drugs are key factors[4].

Market Segmentation

The granisetron hydrochloride market is segmented based on application (oral tablets, injection solutions, patch formulations) and product (nausea and vomiting, chemotherapy-induced nausea, postoperative nausea). Each segment is expected to contribute significantly to the overall market growth, with chemotherapy-induced nausea being a major driver[1].

Impact of COVID-19

The COVID-19 pandemic had a limited but notable impact on the granisetron market. While there were supply chain disruptions and shortages due to lockdowns and healthcare worker illnesses, the overall demand for granisetron remained robust. The pandemic highlighted the need for efficient antiemetic drugs, further solidifying the market's position[3].

Market Restraints

Despite the positive outlook, the granisetron market faces some restraints. The severe side effects of granisetron, such as anxiety, trouble sleeping, and drowsiness, can limit its adoption. However, these side effects are generally manageable, and the benefits of the drug often outweigh the risks[3].

Competitive Landscape

The granisetron market is semi-consolidated, with several key players operating globally and regionally. Major companies include Kyowa Kirin Co., Ltd., Heron Therapeutics, Fresenius SE & Co. KGaA, Hikma Pharmaceuticals, and Viatris. These companies are engaged in various strategic activities such as product launches, collaborations, and expansions to enhance their market presence[4].

Financial Projections

• Market Size: The granisetron hydrochloride market is expected to grow from USD 1.4 billion in 2023 to USD 2 billion by 2031, with a CAGR of 5.2% from 2024 to 2031[1].
• CAGR: The market is projected to register a CAGR of 6.20% during the forecast period from 2024 to 2029, according to some reports[4].

Key Trends and Opportunities

• Personalized Medicine: The increasing demand for personalized medicine and over-the-counter (OTC) products presents opportunities for the granisetron market. Tailored treatment options can enhance patient compliance and overall efficacy[3].
• Postoperative Applications: The use of granisetron in postoperative surgical procedures for preventing and treating nausea and vomiting is another growing trend. This application is expected to boost demand during the forecast period[3].

Pharmacological Overview

Granisetron hydrochloride is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist. Its pharmacokinetics involve rapid absorption, with a peak plasma concentration achieved within a few hours. The drug is metabolized primarily by the liver and excreted through urine and feces. Its efficacy in preventing nausea and vomiting has been well-documented in clinical trials[5].

Clinical Efficacy

Clinical trials have shown that granisetron hydrochloride is highly effective in preventing nausea and vomiting associated with chemotherapy. For instance, a study comparing different doses of granisetron hydrochloride tablets demonstrated significant efficacy in preventing nausea and vomiting 24 hours post-chemotherapy[5].

Key Takeaways

• The granisetron hydrochloride market is driven by the increasing incidence of cancer and advancements in drug formulations.
• North America and Asia-Pacific are key regions contributing to market growth.
• The market faces restraints due to side effects but is expected to grow significantly due to its efficacy and increasing demand.
• Major players are actively involved in strategic activities to enhance their market presence.

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].

Who are the major players in the granisetron market?

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

What are the primary drivers of the granisetron market?

The primary drivers include the rise in cancer cases, advancements in drug formulations, and the expansion of healthcare infrastructure[1][2][4].

What are the common side effects of granisetron hydrochloride?

Common side effects include anxiety, trouble sleeping, and drowsiness[3].

Cited Sources

1. Market Research Intellect: Granisetron Hydrochloride Market Size and Projections.
2. Mordor Intelligence: Granisetron Market Trends.
3. Allied Market Research: Granisetron Market Size, Growth, Share, Industry Insight 2030.
4. Mordor Intelligence: Granisetron Market Size & Share Analysis - Industry Research Report.
5. DailyMed: GRANISETRON HYDROCHLORIDE tablet, film coated.